• Clinical Trials - Breast cancer

    Study Objective Contact
    A Phase I, Open-Label, Multiple-Ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of MSB0010718C in Subjects with Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications. [LCID Study Number: 2013-051] This is a Phase 1, open-label, trial of (Drug) MSB0010718C [antibody targeting anti PD-L1] in subjects with Metastatic Breast Cancer and Metastatic Non Small Cell Lung Cancer. Principal Investigator(s):
    Corrine Zarwan, MD

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

    Study Coordinator(s):
    Julie Roache.
    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 Principal Investigator(s):
    Corrine Zarwan, MD

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

    Study Coordinator(s):
    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.
    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. Principal Investigator(s):
    Stephen E. Karp, MD

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

    Study Coordinator(s):
    Kori D. Hesse.
    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. Principal Investigator(s):
    Corrine Zarwan, MD

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

    Study Coordinator(s):
    Kori D. Hesse.
    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 Cinical 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 Trail: 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.