• Clinical Trials - Breast cancer

    Study Objective Contact
    (NCIC CTG: MA.32) A Phase III Randomized Trial of Metformin versus Placebo on Recurrence and Survival in Early Stage Breast Cancer [LCID Study Number: 2012-007] The purpose of this study is to test the effectiveness, safety and side effects of Metformin for patients with breast cancer. Previous laboratory work has shown that Metformin may decrease the growth of different types of cancer cells, including breast cancer cells. Studies have shown that women with higher levels of insulin (a hormone found in the blood) have a higher rate of breast cancer recurrence. Metformin lowers the level of insulin in the blood and thus may affect breast cancer recurrence. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Corrine Zarwan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Kori D. Hesse.
    A Phase III Trial Evaluating The Role Of Ovarian Function Suppression & The Role Of Exemestane As Adjuvant Therapies For Premenopausal Women With Endocrine Responsive Breast Cancer [LCID Study Number: 2003-065] The study is being done to determine whether the combination of ovarian suppression with tamoxifen or the combination of ovarian suppression with an aromatase inhibitor (exemestane) has the ability to improve survival over that seen with tamoxifen alone in pre-menopausal women with hormone receptor positive early stage breast cancer. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Corrine Zarwan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Donna Cossar,
    Sherry G. Heldt, RN.
    A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Bevacizumab, and Associated Biomarkers, in Combination with Paclitaxel Compared with Paclitaxel Plus Placebo as First-Line Treatment of Patients with HER2- Negative Metastatic Breast Cancer [LCID Study Number: 2012-057] To identify those patients who are most likely to benefit from treatment with bevacizumab by utilizing a simple blood test, and to further understand how bevacizumab, in combination with paclitaxel, may increase the time patients with metastatic breast cancer live, how long the treatment delays the growth of tumor(s), and whether the tumor(s) shrinks. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Corrine Zarwan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Kori D. Hesse.
    A Three Arm, Randomized, Open Label, Phase II Study of Everolimus in Combination with Exemestane versus Everolimus Alone versus Capecitabine in the Treatment of Postmenopausal Women with Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer after Recurrence or Progression on Prior Letrozole or Anastrozole [LCID Study Number: 2013-010] The reason for the study is to determine if either everolimus when given alone or capecitabine are as good as the combination of everolimus and exemestane in stabilizing or stopping progression of breast cancer. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Corrine Zarwan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Kori D. Hesse.
    Breast Cancer Biomarker Sample Collection for the DtectDx Assay Proof of Concept Protocol [LCID Study Number: 2013-062] The purpose of this study is to evaluate a blood test that measures multiple breast cancer-specific biomarker proteins in blood samples to determine if it may help improve the ability to detect breast cancer more accurately. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Rebecca C. Yang, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    .
    CALGB 49801: Phase III Trial Of Observation + / -Tamoxifen vs RT + / - Tamoxifen For Good Risk Duct Carcinoma IN-SITU (DCIS) Of The Female Breast [LCID Study Number: 2000-027] The purpose of this study is to observe treatment with or without tamoxifen as compared to in patients with early stage breast cancer. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Corrine Zarwan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Donna Cossar,
    Su Aras.
    ECOG E5103: A Double-Blind Phase III Trial Of Doxorubicin And Cyclophosphamide Followed By Paclitaxel With Bevacizumab Or Placebo In Patients With Lymph Node Positive And High Risk Lymph Node Negative Breast Cancer [LCID Study Number: 2008-006] A study of chemotherapy plus a monoclonal antibody or chemotherapy plus a placebo in patients with high risk breast cancer. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Neela Natarajan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Donna Cossar,
    Kori D. Hesse.
    Molecular Analysis of Cancer [LCID Study Number: 2011-048] The purpose of this research is to discover molecular changes involved in cancer. We hope that a better understanding of these changes can improve cancer management. This research may include genetic and/or genomic analysis (tests to determine and compare your genetic sequence, or DNA). Some of the tissue we collect for our research may be submitted to the National Cancer Institute Cancer Genome Atlas Project. The goal of this project is to determine the genomic changes involved in more than 20 types of human cancer. Principal Investigator(s):
    Kimberly R. Christ, PhD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Doreen L. Browne, ,CCRP,
    Jane S. Nalwalk,
    Linda M. Topjian.
    Noninvasive Urinary Biomarkers in Tracking Response to Therapy in Women with Metastatic Breast Cancer [LCID Study Number: 2011-095] The purpose of this study is to see whether certain enzymes or other urinary proteins (biomarkers) help predict response to treatment of metastatic breast cancer. Principal Investigator(s):
    Corrine Zarwan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Amanda M. Pietras.
    NRG-BR002: A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic body Radiotherapy(SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer [LCID Study Number: 2015-030CIRB] The main objective of this study is to determine whether removal of metastases (through stereotactic body radiation therapy [SBRT] and/or surgical resection) in oligometastatic breast cancer patients significantly improves overall survival. Principal Investigator(s):
    Andrea B. McKee, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Shawn M. Regis, PhD.
    NSABP B-35: A Clinical Trial Comparing Anastrozole With Tamoxifen In Postmenopausal Patients With Ductal Carcinoma IN SITU(DCIS) Undergoing Lumpectomy With Radiation Therapy (Phase III) [LCID Study Number: 2003-015] This study is being done to find out whether the drug anastrozole is as good as or better than tamoxifen at preventing invasive breast cancer from occurring. This study will also compare the effects (good and bad) of anastrozole and tamoxifen. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Stephen E. Karp, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Donna Cossar,
    Su Aras.
    NSABP B-39/RTOG 0413: A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) For Women With Stage 0, I, II Breast Cancer [LCID Study Number: 2005-026] A study comparing radiation to the entire breast to radiation to only part of the breast. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Corrine Zarwan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Donna Cossar,
    Su Aras.
    NSABP B-42: A Clinical Trial To Determine The Efficacy Of Five Years Of Letrozole Compared To Placebo In Patients Completing Five Years Of Hormonal Therapy Consisting Of An Aromatase Inhibitor (AI) Or Tamoxifen Followed By An AI In Prolonging Disease-Free Survival In Postmenopausal Women With Hormone Receptor Positive Breast Cancer [LCID Study Number: 2006-079] The purpose of this study is to learn whether or not continuing hormonal therapy with an Aromatase Inhibitor (AI) called letrozole for 5 additional years after already taking 5 years of hormonal therapy (which included an AI) can further reduce the chance of breast cancer returning. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Rebecca C. Yang, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Donna Cossar,
    Sherry G. Heldt, RN.
    NSABP B-49: A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node Positive or High-Risk Node-Negative HER2-Negative Breast Cancer [LCID Study Number: 2012-045] This study is being done to find out if a combination of just two chemotherapy drugs, docetaxel and cyclophosphamide, is as good as using different combinations of the chemotherapy drugs doxorubicin and cyclophosphamide, given with either docetaxel or paclitaxel, in treating your type of breast cancer. All of these drugs are used in standard combinations of chemotherapy for breast cancer. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Corrine Zarwan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Kori D. Hesse.
    NSABP Protocol B-38: A Phase III, Adjuvant Trial Comparing Three Chemotherapy Regimens In Women With Node-Positive Breast Cancer: Docetaxel/Doxorubincin/Cyclophosphamide(TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed By DD Paclitaxel (DD AC->P); DD AC Followed By DD Paclitaxel Plus Gemcitabin (DD AC->PG) [LCID Study Number: 2004-097] The purpose of this study is to compare the effects (good and bad) of three combinations of chemotherapy drugs to find out which is best at treating patietns witih node positive breast cancer. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Corrine Zarwan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Donna Cossar,
    Su Aras.
    NSABP Protocol B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently With Radiation Therapy And Radiation Therapy Alone For Women With HER2-Positive Ductal Carcinoma In Situ Resected By Lumpectomy [LCID Study Number: 2008-098] This study is being done to compare the effects, good and/or bad, of adding the drug trastuzumab (also called Herceptin®) to breast radiation therapy. Radiation therapy is the standard treatment for patients with DCIS. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Stephen E. Karp, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Donna Cossar,
    Sherry G. Heldt, RN.
    PRESENT: Prevention of Recurrence in Early Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment [LCID Study Number: 2012-005] The purpose of this study is to evaluate the safety and effectiveness of the investigational drug, NeuVax, in preventing the recurrence of node-positive (when cancer is found in the lymph nodes), early stage breast cancer, with low to intermediate HER2 expression (Her-2 negative). NeuVax is an investigational drug, which means it is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA). It is a protein vaccine being developed for use after completion of standard of care therapy for early stage breast cancer to potentially prevent recurrence of the cancer. The safety of NeuVax in humans has been tested in prior research studies. This study will continue to collect information on safety, and will test NeuVax’s effectiveness. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Corrine Zarwan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Kori D. Hesse.
    Program For The Assessment Of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options For Treatment: The TAILORx Trial [LCID Study Number: 2008-019] The purpose of this study is to determine whether patients who have a tumor with an Oncotype DX Recurrence Score of 11-25 benefit from chemotherapy, and to confirm that patients who have Oncotype DX Recurrence Score of < 10 have a very low risk of recurrence with hormonal therapy alone (and do not need chemotherapy to reduce their risk of recurrence). THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Neela Natarajan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Kori D. Hesse.
    Prospective Registry of Mammaprint in Breast Cancer Patients with an Intermediate Recurrence Score (PROMIS) [LCID Study Number: 2012-053] The purpose of this registry study is to assess information obtained from the Agendia Breast Cancer Suite of diagnostic tests and other clinical information to study ways to assist in breast cancer diagnosis and treatment decisions. The Agendia Breast Cancer Suite includes MammaPrint®, TargetPrint®, and BluePrint™ which are tests that help your doctor analyze and profile your breast cancer tumor. Principal Investigator(s):
    Corrine Zarwan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Amanda M. Pietras.
    S0307: Phase III Trial Of Bisphosphonates As Adjuvant Therapy For Primary Breast Cancer [LCID Study Number: 2009-037] The purpose of this study is to find out if adding a bisphosphonate drug to hormonal therapy or chemotherapy will help prevent cancer from spreading to the bones or other parts of the body in patients with breast cancer in remission. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Corrine Zarwan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Kori D. Hesse.
    S0812, A Randomized, Double-Blind, Placebo-Controlled, Biomarker Modulation Study of High Dose Vitamin D in Premenopausal Women at High Risk for Breast Cancer, Phase IIB [LCID Study Number: 2011-086] A biomarker is a biologic test (for example, a mammogram, tissue or blood test) which may predict who will develop breast cancer in the future. The purpose of this study is to see if vitamin D affects breast tissue by reducing breast tissue thickness (the amount of glandular breast tissue compared to fat) on a mammogram (a special imaging exam of the breast that uses x-rays) and if it reduces the growth of breast cells. Also, we want to find out what effects on the breast and also side effects vitamin D has. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Corrine Zarwan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Julie Roache.
    S1007: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial RX for Positive Node, Endocrine Responder Breast Cancer [LCID Study Number: 2011-049] The Oncotype DX® breast cancer test is a test that looks at multiple genes related to breast cancer. The combination of the test results produces a score that is useful in guiding treatment choices for patients with node-negative breast cancer. The higher the score, the more likely that the patient’s breast cancer will come back after surgery. The Oncotype DX® test is a commercially available test that is already being used to assess the risk that breast cancer will come back after surgery. The performance of the test is not part of the research question in this study. The purpose of this part of this experimental study is to send your breast cancer tissue for Oncotype DX® recurrence score testing to find out if you may be eligible to participate in the next part of the study. Principal Investigator(s):
    Corrine Zarwan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Jo A. Underhill, RN-BSN,
    Kori D. Hesse.
    S1200: Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women with Early Stage Breast Cancer [LCID Study Number: 2013-058] Acupuncture is a traditional Chinese medical treatment which involves the use of very small, thin needles to stimulate specific points in the body. This study will test whether acupuncture can reduce joint pain associated with aromatase inhibitor therapy for breast cancer. In a previous study, women with aromatase inhibitor induced joint pain treated with acupuncture had a significant improvement of joint pain and stiffness. The purpose of this study is to test whether 12-week use of acupuncture can be used to ease joint pain or stiffness related to aromatase inhibitors for breast cancer treatment. We want to find out what effects, good and/or bad, it has on you and your joint symptoms. Principal Investigator(s):
    Corrine Zarwan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Amanda M. Pietras.
    S1207, Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everloimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. e3 Breast Cancer Study-Evaluating Everolimus with Endocrine Therapy [LCID Study Number: 2013-080] The primary objective of this study is to compare whether the addition of one year of everolimus (10 mg daily) to standard endocrine therapy improves invasive disease-free survival (IDFS) in patients with high-risk, hormone-receptor (HR) positive and HER2-negative breast cancer. Principal Investigator(s):
    Corrine Zarwan, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Kori D. Hesse.
    S1222: Fulvestrant Alone Versus Fulvestrant and Everolimus versus Fulvestrant, Everolimus and Anastrozole: A Phase III Randomized Placebo-Controlled Trial in Postmenopausal Patients with Hormone-Receptor Positive Stage IV Breast Cancer [LCID Study Number: 2014-021] The purpose of this study is to find out what effects, good and/or bad, adding the drugs anastrozole and everolimus to regular treatment with fulvestrant has on patients with stage IV breast cancer. Anastrozole, everolimus and fulvestrant are all approved by the Food and Drug Administration for the treatment of metastatic breast cancer. However, it is the combination of the three drugs that is considered experimental. A second purpose of this study is to determine if there are some patients who are more or less likely to benefit from adding either of these drugs to fulvestrant, or even if there are patients with hormone receptor positive breast cancers who will not respond to any of these three drugs. Principal Investigator(s):
    Paola F. Rode, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Kori D. Hesse.
    Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-Conserving Surgery [LCID Study Number: 2014-020] This purpose of this registry study is to collect long term outcome data on the use of targeted intraoperative radiation therapy (IORT) provided during lumpectomy surgery in women with early stage breast cancer. Principal Investigator(s):
    Rebecca C. Yang, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Donna Cossar,
    Shawn M. Regis, PhD.