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ECOG EA1131

A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Observation in Patients with Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Lauren Downing, BS
    484-526-7936

    Lauren.downing@sluhn.org
  • Treatment Agent: Carboplatin; Cisplatin

    Synopsis: This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to observation in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than observation in treating patients with residual triple negative basal-like breast cancer.

    • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 2 weeks prior to screening
    • Female and male patients must have histologically confirmed triple negative (estrogen receptor negative [ER-]/progesterone receptor negative [PR-]/human epidermal growth factor receptor-2 negative [HER2-]) invasive breast cancer, clinical stage II-III at diagnosis (American Joint Committee on Cancer [AJCC] 7th edition) based on initial evaluation by clinical examination and/or breast imaging
      • ER- and PR- should meet one of the following criteria:
        • =< 10% cells stain positive, with weak intensity score (Allred score =< 2)
        • =< 1% cells stain positive, with weak or intermediate intensity score (Allred score =< 2)
      • HER2 negative (not eligible for anti-HER2 therapy) will be defined as:
        • Immunohistochemistry (IHC) 0, 1+ without in situ hybridization (ISH) HER2/neu chromosome 17 ratio OR
        • IHC 2+ and ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number < 6 signals/cells OR
        • ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number < 6 signals/cells without IHC
        • NOTE: Patients that originally present with synchronous bilateral tumors are eligible provided both tumors are TNBC, and at least one of them fulfills the remainder eligibility criteria of the protocol
    • Patients must have completed neoadjuvant taxane +/- anthracycline; patients must NOT have received cisplatin or carboplatin as part of their neoadjuvant therapy regimen
      • NOTE: Patients who received preoperative therapy as part of a clinical trial may enroll
    • Must have completed definitive resection of primary tumor
      • Negative margins for both invasive and ductal carcinoma in situ (DCIS) are desirable, however patients with positive margins may enroll if the treatment team believes no further surgery is possible and patient has received radiotherapy; patients with margins positive for lobular carcinoma in situ (LCIS) are eligible
      • Either mastectomy or breast conserving surgery (including lumpectomy or partial mastectomy) is acceptable
      • Sentinel node biopsy post neoadjuvant chemotherapy (i.e. at the time of definitive surgery) is allowed; axillary dissection is encouraged in patients with lymph node involvement, but is not mandatory
    • Post neoadjuvant chemotherapy, patients must be found to have residual invasive cancer in the breast at the time of definitive surgery; residual cancer is defined as a contiguous focus of residual invasive cancer, in the breast, measuring >= 1 cm in diameter, and with more than minimal cellularity, as per local pathologist determination
      • NOTE: The presence of ductal carcinoma in situ (DCIS) without invasion does not qualify as residual invasive disease in the breast
    • Post-mastectomy radiotherapy is required for all patients with the following:
      • Primary tumor >= 5 cm (prior to neoadjuvant chemotherapy [clinically] or at the time of definitive surgery) or involvement of 4 or more lymph nodes at the time of definitive surgery
      • For patients with primary tumors < 5 cm or with < 4 involved lymph nodes prior to neoadjuvant chemotherapy and at the time of definitive surgery, provision of post-mastectomy radiotherapy is at the discretion of the treating physician
        • NOTE: Radiation of regional nodal basins is at the discretion of the treating radiation oncologist; patients enrolled in clinical trials addressing local therapy after neoadjuvant chemotherapy are allowed to enroll
    • Whole breast radiotherapy is required for patients who underwent breast-conserving therapy, including lumpectomy or partial mastectomy
    • Laboratory values must be obtained within 8 weeks prior to screening for protocol therapy
    • Hemoglobin (Hgb) > 9.0 g/dL
    • Platelets > 100 mm^3
    • Absolute neutrophil count (ANC) > 1500 mm^3v
    • Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula
    • Bilirubin =< 1.5 x ULN upper limit of normal (except in patients with documented Gilbert's disease, who must have a total bilirubin =< 3.0 mg / dL)
    • Aspartate aminotransferase (AST, serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 x upper limit of normal (ULN)
    • Alanine aminotransferase (ALT, serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN
    • No stage IV (metastatic) disease, however no specific staging studies are required in the absence of symptoms or physical exam findings that would suggest distant disease
    • No clinically significant infections as judged by the treating investigator
    • Patients with active >= Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4 grade 2 neuropathy are ineligible
    • Adjuvant chemotherapy after surgery other than that specified in this protocol is not allowed; luteinizing hormone-releasing hormone (LHRH) agonists and adjuvant bisphosphonate use is allowed
    • Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the residual disease on the definitive surgical specimen available for PAM50 analysis to determine patient eligibility
      • Tumor tissue specimen from the definitive surgery has been collected and is ready to ship to the ECOG-American College of Radiology Imaging Network (ACRIN) Central Biorepository and Pathology Facility (CBPF) within 12 weeks post-surgery
      • The Molecular Diagnostics Laboratory (MDL) at MD Anderson Cancer Center will perform the PAM50 analysis and forward results (eligible versus non-eligible) within three (3) weeks of receipt of the tumor tissue specimen to the ordering physician via FAX and to the ECOG-ACRIN Operations Office via secure electronic messaging to the ECOG-ACRIN database
        • NOTE: Every effort should be made to submit the tumor tissue specimen to the ECOG-ACRIN CBPF immediately; tumor tissue cannot be accepted after 12 weeks (post surgery) in order to allow for PAM50 analysis
    • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): For patients randomized to the chemotherapy arm, cycle 1/day 1 must start within 1 week (5 working days) following randomization
    • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Must have basal-like gene expression on PAM50 analysis by digital mRNA quantitation on the formalin-fixed paraffin-embedded tumor tissue specimen (FFPE) of the residual disease in the breast or axilla resected at the time of definitive surgery
    • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): ECOG performance status 0 or 1 within 2 weeks prior to randomization
    • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must have completed adjuvant radiotherapy >= 2 weeks prior to randomization for protocol therapy, if applicable
    • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must have completed treatment with any investigational agent >= 30 days prior to randomization for protocol therapy, if applicable
    • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must be randomized within 15 weeks from surgery
    • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy
      • A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months
    • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
    • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Hemoglobin (Hgb) > 9.0 g/dL
    • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Platelets > 100 mm^3
    • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Absolute neutrophil count (ANC) > 1500 mm^3
    • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Calculated creatinine clearance of > 50 mL/min
    • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Bilirubin =< 1.5 x ULN (except in patients with documented Gilbert's disease, who must have a total bilirubin =< 3.0 mg / dL)
    • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Aspartate aminotransferase (AST, SGOT) =< 2.5 x ULN
    • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Alanine aminotransferase (ALT, SGPT) =< 2.5 x ULN

Genentech GO29831 

A Phase Ib, Open-Label Study Evaluating The Safety And Pharmacokinetics Of Atezolizumab (Anti?Pd-L1 Antibody) In Combination With Trastuzumab Emtansine Or With Trastuzumab And Pertuzumab (With And Without Docetaxel) In Patients With Her2-Positive Breast Cancer And Atezolizumab With Doxorubicin And Cyclophosphamide In Her2-Negative Breast Cancer

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Robyn Rex, RN, CCRP
    484-503-4152

    robyn.rex@sluhn.org
  • Treatment Agent: Atezolizumab, Herceptin, Pertuzumab, Trastuzumab

    Synopsis: The main purpose of this study is to find out the risks and discomforts, atezolizumab has on you and your cancer when combined with the 1) HER2-targeted drugs, trastuzumab, pertuzumab (with and without docetaxel), and trastuzumab emtansine in HER2-positive breast cancer, and 2) cyclophosphamide and doxorubicin in HER2-negative breast cancer. Cancers overexpressing HER2 may be treated with targeted therapies such as trastuzumab and pertuzumab and, in the case of advanced cancer, trastuzumab emtansine.

    Other purposes of the study are to determine how much of the study drug, atezolizumab, is in your blood and how your body gets rid of it (known as pharmacokinetic or “PK” measurements). For patients receiving the various HER2-targeted drugs, the amount of these drugs in your blood will also be evaluated. Another purpose of the study is to see how atezolizumab in combination with either trastuzumab and pertuzumab, or trastuzumab emtansine affects the growth of your tumors.



    • Histologically documented HER2-positive and HER2-negative (cohort E only) breast cancer
    • Metastatic breast cancer that is measurable (Stage 1) or early breast cancer with a primary tumor size greater than (>) 2 centimeter (cm) (Stage 2)
    • Eastern cooperative oncology group (ECOG) performed status of 0, 1 or 2; 0 or 1 (cohort E only)
    • Life expectancy of 12 or more weeks
    • Adequate hematologic and end-organ function
    • Left ventricular ejection fraction greater than or equal to (>=) 50 percentage (%); >=55% (cohort E only)
    • Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
    • Leptomeningeal disease
    • Pregnancy or lactation
    • History of autoimmune disease
    • Prior allogeneic stem cell or solid organ transplantation
    • Positive test for human immunodeficiency virus (HIV)
    • Active hepatitis B or hepatitis C

Pfizer A5481074

Prospective Observational Study of Mobile App-Based Patient-Reported Outcomes in Advanced Breast Cancer (Madeline)

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Lauren Downing, BS
    484-526-7936

    Lauren.downing@sluhn.org
  • Treatment Agent: N/A

    Synopsis: You are eligible to take part in this research study because you are beginning treatment for locally advanced or metastatic hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2–) breast cancer. There is a need to learn more about the experiences and quality of life among patients who are being treated for this disease. For this reason, Pfizer is conducting a non-interventional study to collect information about the effects of breast cancer and its treatment on patients’ day-to-day activities and quality of life.

    • Owns or has regular access to an Apple iPhone (version 5.0 or higher with latest software: iOS 9.0 or higher) or Android phone (e.g., Nexus or Galaxy with latest software: version 4.4.2 or higher).
    • Postmenopausal adult women (≥ 18 years of age) with diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or locoregionally advanced disease not amenable to resection or radiation therapy with curative intent.
    • Documented evidence of HR+ tumor based on the patient’s most recent tumor biopsy.
    • Documented evidence of an HER2– tumor based on the patient’s most recent tumor biopsy. HER2– is determined as an immunohistochemistry score of 0/1+ or negative by in situ hybridization (FISH/CISH/SISH) defined as a HER2/CEP17 ratio < 2 or, for single probe assessment, a HER2 copy number < 4).
    • Initiating first, second or third line treatment with one of the following therapies: IBRANCE and letrozole as initial endocrine-based therapy for advanced or metastatic disease as per label, or IBRANCE with fulvestrant if the patient has experienced disease progression following endocrine therapy as per label, or other approved therapy as the first treatment for advanced or metastatic breast cancer, or initiating other approved therapy as the second or third treatment for ABC or mBC.
    • Evidence of a personally signed and dated informed consent form document indicating that the patient has been informed of all pertinent aspects of the study.
    • Able to read and understand English
    • Willing and able to complete collection of data via mobile app.
    • Patient is initiating neoadjuvant systemic therapy.
    • In the judgment of the investigator, the patient’s life expectancy is fewer than 3 months at the time of diagnosis of ABC or mBC.
    • The patient is participating in any interventional clinical trial that includes investigational or marketed products. Patients participating in other investigator initiated research or non-interventional studies can be included as long as their standard of care is not altered by the study.
    • The patient is on active treatment for other malignancies other than ABC or mBC.

Pfizer A5481082

POLARIS: Palbociclib in Hormone Receptor Positive Advanced Breast Cancer: A Prospective Multicenter Non-Interventional

Study

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Lauren Downing, BS
    484-526-7936

    Lauren.downing@sluhn.org
  • Treatment Agent: N/A

    Synopsis: You are being asked to take part in this research study because you have breast cancer. There is a need to learn more about the use of palbociclib in routine clinical practice. For this reason, Pfizer is conducting a prospective non-interventional study to collect additional information on the good and bad effects of the drug, palbociclib, which has been prescribed to you by your doctor.

    The main goal of this study is to describe and analyze the prescribing and treatment patterns of palbociclib in routine clinical practice. The study will collect and assess information related to how you are treated by your doctor and also it will collect information about your experience.

  • 1. Age ≥18 years or older.
    2. Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to treatment with curative intent.
    3. Documented HR+ (ER+ and/or PR+) tumor based on local standards.
    4. Documented HER2- tumor based on local standards.
    5. Physician has determined that treatment with palbociclib is indicated.
    6. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
    7. Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits as per standard of care practice at the site.

    • Patients with a life expectancy of less than 3 months at the time of ABC diagnosis, per the investigator’s judgment.
    • Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study).
    • Patients on active treatment for malignancies other than ABC at the time of enrollment.
    • Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent.

SWOG 1207

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Lauren Downing, BS
    484-526-7936

    Lauren.downing@sluhn.org
  • Treatment Agent: Everolimus

    Synopsis: The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney or breast cancer. It is considered investigational for non-metastatic breast cancer patients. In this study you will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormone-treatment and everolimus is experimental in patients with breast cancer.

    • Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen (ER)- and/or progesterone-receptor (PR) status, and negative human epidermal growth factor receptor (HER)2, for whom standard adjuvant endocrine therapy is planned
      • ER and PR positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as either ER or PR ≥ 1% positive nuclear staining
      • HER2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using IHC, ISH or both. HER2 is negative if a single test (or all tests) performed in a tumor specimen show:
        • IHC negative (0 or 1+)
        • ISH negative using single probe or dual probe. If IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+. HER2 equivocal is not eligible.
    • Patients must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral, and primary inflammatory breast cancers are allowed
      • Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant
      • Multicentric disease is defined as more than one invasive cancer ≥ 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants
      • Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other
    • Patients must be high risk by belonging to one of the following risk groups:
      • Completion of adjuvant chemotherapy and pathologically negative axillary nodes, and a tumor measuring ≥ 2 cm in greatest diameter, and an Oncotype DX® recurrence score (RS) > 25 (completed as standard of care)
      • Completion of adjuvant chemotherapy, and pathologically 1-3 positive axillary lymph nodes, and an Oncotype DX® RS > 25 (screened via S1007 or otherwise)
      • Completion of adjuvant chemotherapy and pathologically 4 or more positive axillary lymph nodes independent of the Oncotype DX® RS in the primary tumor
      • Completion of neoadjuvant chemotherapy and 4 or more positive nodes pathologically determined prior to or after chemotherapy
    • Patients must have completed either breast-conserving surgery or total mastectomy, with negative margins and appropriate axillary staging; a negative margin is defined as no evidence of tumor or ductal carcinoma in situ (DCIS) at the line of resection; additional operative procedures may be performed to obtain clear margins
      • Patients who had breast-conserving surgery must have completed whole-breast radiation; use of regional nodal-basin radiation will be at the discretion of the investigator according to institutional guidelines
      • Patients with ≥ 4 positive lymph nodes must have completed breast/chest wall and nodal-basin radiation therapy according to standard-of-care guidelines before randomization; omission of radiation therapy is not allowed in this high-risk population of patients
      • Patients must be registered no sooner than 21 days after completion of radiation therapy and must have recovered (≤ grade 1) from any of the effects of radiation
    • Patients must have undergone axillary staging by sentinel-node biopsy or axillary lymph node dissection (ALND)
      • For patients with 1-3 positive lymph nodes, sentinel-node biopsy alone is allowed provided that the patient completed either whole-breast or chest-wall radiation and the primary tumor is < 2 cm
      • All patients with ≥ 4 positive lymph nodes must have completed ALND (with or without prior sentinel-node biopsy)
    • Peripheral granulocyte count ≥ 1,500/mL
    • Hemoglobin ≥ 9 g/dL
    • Platelet count ≥ 100,000/mL
    • Bilirubin ≤ 1.5 mg/dL (≤ 3.0 mg/dL if due to Gilbert syndrome)
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times institutional upper limit of normal (IULN)
    • Alkaline phosphatase ≤ 1.5 times IULN
    • Serum creatinine level ≤ IULN
    • Fasting cholesterol ≤ 300 mg/dL and triglycerides ≤ 2.5 times IULN; patients may be on lipid-lowering agents to reach these values
    • Patients must have a performance status of 0-2 by Zubrod criteria
    • Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
    • Patients must not have uncontrolled diabetes (defined as a hemoglobin [Hg] A1C > 7% within 28 days prior to registration)
    • Patients known to be human immunodeficiency virus (HIV) positive may be enrolled if baseline CD4 count is > 500 cells/mm³ and they are not taking anti-retroviral therapy
    • Patients with known hepatitis are not eligible
    • Patients must not have any known uncontrolled, underlying pulmonary disease
    • Patients must be able to take oral medications
    • Patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of blinded drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
    • Patients must not be pregnant or nursing
    • Women/men of reproductive potential must have agreed to use an effective non-hormonal contraceptive method during and for 8 weeks after completion of study therapy
      • In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; corresponding procedures for men include castration, vasectomy, and barrier-contractive devices
      • If at any point a previously celibate patient chooses to become heterosexually active during the protocol therapy, he/she is responsible for beginning contraceptive measures
    • No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years
    • Patients must have completed standard neoadjuvant or adjuvant chemotherapy prior to randomization; completion of chemotherapy will be determined by the treating oncologist, but should include a minimum of 4 courses (a course of weekly paclitaxel is considered 3 doses); patients must be registered within 21 weeks after completion of chemotherapy; patients may have started endocrine therapy at any time after the diagnosis of the current breast cancer
    • Patients must not be receiving or planning to receive trastuzumab
    • Concurrent bisphosphonate therapy is allowed
    • Patients must not have prior exposure to mTOR inhibitors (rapamycin, everolimus, temsirolimus, deforolimus)
    • Patients must not have prior treatment with any investigational drug within the preceding 28 days and must not be planning to receive any other investigational drug for the duration of the study
    • Patients must not be planning to receive any other anticancer drug for the duration of the study
    • Patients must not have an organ allograft or other history of immune compromise; patients must not be receiving chronic, systemic treatment with corticosteroids or other immunosuppressive agent; topical or inhaled corticosteroids are allowed
    • Patients must not have received immunization with an attenuated live vaccine (e.g., intranasal influenza, measles, mumps, and rubella [MMR], oral polio, varicella, zoster, yellow fever, and Bacillus Calmette-Guérin [BCG] vaccines) within seven days prior to registration nor have plans to receive such vaccination while on protocol treatment
    • Patients must not have taken within 14 days prior to registration, be taking, nor plan to take while on protocol treatment, strong cytochrome P450 3A4 (CYP3A4) inhibitors and/or CYP3A4 inducers

Agendia FLEX 

MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Physician

    Lee Riley, MD

    Lee Riley, MD

    Study Coordinator

    Lauren Downing, BS
    484-526-7936

    Lauren.downing@sluhn.org
  • Treatment Agent: N/A

    Synopsis: You have been asked to consider taking part in this registry because you are being treated for stage I, stage II,or stage III breast cancer. If you participate, your doctor will receive the results of the Agendia Breast Cancer Suite (MammaPrint and BluePrint). 

    The purpose of this registry is to create a large-scale, population-based database. This database will match health information to genome information to look at the Agendia Breast Cancer suite and new gene associations. The Agendia Breast Cancer Suite includes MammaPrint® and BluePrint™, which are tests that help your doctor analyze and profile your breast cancer tumor. DiscoverPrint is for research purposes only and the results will not be made available for use in your current breast cancer management.

    • MammaPrint, an FDA cleared test, is used clinically to determine your risk for distant metastasis.
    • BluePrint provides physicians with more information about their patient’s unique tumor biology.
    • DiscoverPrint will allow the study of new gene associations and additional biomarkers that may be found to be relevant to breast cancer therapy and diagnosis.
    • Breast cancer with different biological properties may respond different to certain therapies.
    • Stage I-III patients with a MammaPrint and BluePrint result (male or female)
    • Informed consent form signed on the same day or before enrollment
    • Eligible to receive chemotherapy and endocrine therapy as defined by a good Karnofsky index (≥80)
    • Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
    • Metastatic disease

Alliance A011104 

Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Physician

    Lee Riley, MD

    Lee Riley, MD

    Study Coordinator

    Lauren Downing, BS
    484-526-7936

    Lauren.downing@sluhn.org
  • Treatment Agent: N/A

    Synopsis:The purpose of this study is to test whether patients undergoing a breast MRI (magnetic resonance imaging) before breast surgery will have better results after the surgery.

    MRI is a medical imaging method that uses magnets to make images of the body. MRI helps doctors to tell the difference between cancer and normal tissue in the body. MRI uses dyes (“contrast agents”) that are injected into the veins to help create the images of the body’s tissues.

    Breast tumors are routinely evaluated using mammograms and ultrasound before surgery. This study would like to find out if using MRI in addition to mammography before surgery improves our ability to evaluate tumors and decide what kind of surgery is best for the patient.

    The goals of this study are:

    • To see if using MRI improves decision-making when choosing what type of surgery is best for the patient (mastectomy or lumpectomy).
    • To see if using MRI affects how well patients do after surgery.
    • To examine the effect of using MRI on patients’ quality of life.
    • To examine the effect of MRI on overall medical costs.
    • Female. Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer.
    • Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0). Diagnosis must be by needle biopsy; patients diagnosed by surgical excision are excluded.
    • Patients must have either:
      • Estrogen receptor (ER) negative/progesterone receptor (PR) negative (< 10% by immunohistochemistry IHC staining) and HER-2 negative breast cancer OR
      • ER negative/PR negative (< 10% by IHC staining) and HER-2 positive tumors
      • HER-2 status will be determined as per the 2013 ASCO CAP guidelines:

        • HER-2 is considered positive if there is IHC 3+ staining or ISH positive using either single probe ISH or dual probe ISH
        • HER-2 is considered negative if there is IHC 0 or 1+ staining or ISH negative using either single probe ISH or dual probe ISH
    • No patients with previous ipsilateral invasive breast cancer or ductal carcinoma in situ (DCIS)
    • No patients with bilateral breast cancer
    • No patients with known deleterious mutations in breast cancer (BRCA) genes
    • No current history of receiving hormonal therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures
    • No history of chemotherapy for cancer within 6 months prior to registration
    • No patients scheduled to receive neoadjuvant chemotherapy or partial breast irradiation following breast conserving surgery
    • Eligible for BCT based on clinical examination, mammography and, if standard practice at a given institution, ultrasound and/or tomogram. Women who cannot be appropriately selected for BCT based on these standard imaging studies, and for whom additional imaging is recommended to clarify local disease extent, will not be eligible for this trial.
    • No patients with multicentric or multifocal disease scheduled to undergo multiple lumpectomies. Multifocal disease that can be encompassed in a single operative bed can be enrolled.
    • Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow):
      • No history of untreatable claustrophobia
      • No presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)
      • No history of sickle cell disease
      • No contraindication to intravenous contrast administration
      • No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance
      • No findings consistent with renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m^2 based on a creatinine level obtained within 28 days prior to registration
      • Weight lower than that allowable by the MRI table
    • No prior MRI of study breast within the 12 months prior to registration
    • Non-pregnant and non-lactating. Patients of child-bearing potential must have a negative pregnancy test within 7 days prior to registration. Perimenopausal patients must be amenorrheic > 12 months to be considered not of child-bearing potential
    • ≥ 18 years of age
    • Signed study-specific informed consent prior to registration

NSABP B-51/RTOG 1304

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Lauren Downing, BS
    484-526-7936

    Lauren.downing@sluhn.org
  • Treatment Agent: Radiation

    Synopsis: The main purpose of this clinical trial is to study women like you who have cancer cells in the lymph nodes at the time that the breast cancer is diagnosed and have chemotherapy before surgery that clears the cancer cells from the lymph nodes. For women with breast cancer who do not have cancer cells in the lymph nodes removed at surgery, radiation is usually given to the breast only after lumpectomy and not at all after mastectomy.

    This study asks if adding radiation to the lymph nodes (after lumpectomy) or adding radiation to the area where the breast used to be and the lymph nodes (after mastectomy) is better at keeping the cancer from returning. It also asks whether giving radiation as described above will help women live longer.

    • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
    • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy); clinical axillary nodal involvement can be assessed by palpation, ultrasound, CT scan, magnetic resonance imaging (MRI), positron emission tomography (PET) scan, or PET/CT scan
    • Patient must have had pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on either a positive fine needle aspirate (FNA) (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma); the FNA or core needle biopsy can be performed either by palpation or by image guidance; documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy) is not permitted
    • Patients must have had estrogen receptor (ER) analysis performed on the primary breast tumor before neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP guideline recommendations for hormone receptor testing (http://www.asco.org)
    • Patients must have had HER2 testing performed on the primary breast tumor before neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations for human epidermal growth factor receptor 2 testing in Breast Cancer (http://www.asco.org); patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible
    • Patient must have completed a minimum of 12 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen
    • For patients who receive adjuvant chemotherapy after surgery, a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization; (if treatment delays occur, chemotherapy must be completed within 14 weeks); the dose and schedule of the adjuvant chemotherapy are at the investigator's discretion; Note: It is preferred that all intended chemotherapy be administered in the neoadjuvant setting
    • Patients with HER2-positive tumors must have received neoadjuvant trastuzumab or other anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated
    • At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer; acceptable procedures for assessment of axillary nodal status at the time of surgery include:
      • Axillary node dissection
      • Sentinel node biopsy alone or
      • Sentinel node biopsy followed by axillary node dissection
      • Note: Patients are eligible whether there is residual invasive carcinoma in the surgical breast specimen or whether there is evidence of pathologic complete response; patients who are found to be pathologically node-positive at the time of surgery, based on sentinel node biopsy alone, are candidates for A011202, a study developed by the Alliance in Oncology, an NCI Cooperative Group; if A011202 is open at the investigator's institution, patients should be approached about participating in the A011202 study
    • Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible (Note: Postneoadjuvant therapy is designated with a "yp" prefix.)
    • Patient who have undergone either a total mastectomy or a lumpectomy are eligible
    • For patients who undergo lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS as determined by the local pathologist; additional operative procedures may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection)
    • For patients who undergo mastectomy, the margins must be histologically free of residual (microscopic or gross) tumor
    • The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 56 days; also, if adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 56 days
    • The patient must have recovered from surgery with the incision completely healed and no signs of infection
    • If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved
    • Definitive clinical or radiologic evidence of metastatic disease
    • T4 tumors including inflammatory breast cancer
    • Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone
    • N2 or N3 disease detected clinically or by imaging
    • Patients with histologically positive axillary nodes post neoadjuvant therapy
    • Patients with microscopic positive margins after definitive surgery
    • Synchronous or previous contralateral invasive breast cancer or DCIS; (patients with synchronous and/or previous contralateral LCIS are eligible)
    • Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy; (patients with synchronous or previous ipsilateral LCIS are eligible)
    • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization
    • Any radiation therapy for the currently diagnosed breast cancer prior to randomization
    • Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization
    • Prior breast or thoracic radiation therapy (RT) for any condition
    • Active collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma
    • Pregnancy or lactation at the time of study entry; (Note: Pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential)
    • Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
    • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements