Open Clinical Trials at the Dubin Breast Center

Breast Cancer Biospecimen Repository: To bank tumor tissue from patients with invasive breast cancers for the current and future research of the Dubin Breast Center of the Tisch Cancer Institute at Mount Sinai.

  • Description: In order to study mechanisms of breast cancer treatment resistance or metastases, it is important for researchers to have access to tumor samples that enable comparative analysis (pre- vs. post-treatment; primary vs. recurrent or metastatic breast cancer). Analysis of gene expression profiles and cell signaling in these specimens may improve our treatment approaches for primary and metastatic breast cancer.
  • Contact: Kereeti V. Pisapati, MS; 212-241-2475

A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer

  • Description: This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2-  Stage II or III Early breast cancer. The The Primary Objective  is  to compare invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone.
  • Contact: Joni Gomes, RN BSN OCN; (212) 824-7076/ 7659

A randomized phase II trial of fulvestrant with or without Ribociclib after progression on aromatase inhibition plus cyclin-dependent kinase 4/6 inhibition in patients with unresectable or metastatic hormone receptor positive, HER2 negative breast cancer

  • Description: To evaluate the progression-free survival (PFS) of fulvestrant with or without ribociclib after progression on an aromatase inhibitor plus cyclin-dependent kinase 4/6 inhibitor in patients with hormone receptor positive (HR+), HER2- breast cancer.
  • Contact: Joni Gomes, RN BSN OCN; (212) 824-7076/ 7659

Circulating tumor cells and Natural Killer cell activity in the prognosis of patients diagnosed with triple negative breast cancer.

  • Description: Triple negative breast cancer (TNBC) represents an aggressive, genomically heterogeneous, subtype of breast cancer with few targeted therapeutic options. Personalized treatment and recurrence risk management for patients with TNBC requires an improved understanding of the genomic landscape of individual breast tumors, better predictive models of response to specific therapeutic agents and improved biomarkers for prognosis. This study will enhance our understanding of the significance of circulating tumor cells and cell free DNA as biomarkers of treatment response and predictors of long term outcomes for patients with TNBC.
  • Contact: Kereeti V. Pisapati, MS; 212-241-2475

Patient-Derived Xenograft (PDX) Modeling of Treatment Response for Triple Negative Breast CancerTo assess whether the response of PDX tumors to cytotoxic agents in the Champions Oncology Tumor GraftTM (COTG) assay correlates with responses observed in patients receiving treatment at Dubin.

  • Description: This study will determine if patient-derived tumor xenograft (PDX) mouse models can serve as a reliable model for treatment response for individual patients with triple negative breast cancer. The collection of patient tumor tissue will also provide insight into the mechanisms of therapeutic resistance.
  • Contact: Kereeti V. Pisapati, MS; 212-241-2475

Transgender Follow-up Imaging Registry (TransFIR): To assess the rate of cancer detection in transgender individuals screened by mammography.

  • Description: Transgender individuals referred for mammography are eligible to join a prospective study to evaluate the rate of abnormal findings and cancer detection by mammography and breast imaging.
  • Contact: Emily B. Sonnenblick, MD; 212-241-3300

Phase I/II Trial of Ruxolitinib in combination with Trastuzumab in Metastatic Her2 positive breast cancer

  • Description: The purpose of this study is to examine the safety and effectiveness of ruxolitinib in combination with trastuzumab in the treatment of HER2 positive metastatic breast cancer.  HER2 positive breast cancer is a breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promoted the growth of cancer cells. Ruxolitinib (Jakafi) is an FDA approved treatment of myelofibrosis (a disease of the bone marrow), but it's safety and effectiveness in breast cancer patients is not known. Ruxolitinib is being used in an investigational manner in this research study.  Ruxolitinib is a type of therapy that inhibits the JAK/STAT growth pathway.  Research in the lab shows that this pathway is important for HER2 positive breast cancers to grow.  This drug is targeted to stop that pathway. Trastuzumab (Herceptin) is an FDA approved treatment for HER2 positive breast cancer.  The safety and efficacy of both treatments given in combination is not known.
  • Contact: Joni Gomes, RN BSN OCN; (212) 824-7076/ 7659

A011106- ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant TrEatment (ALTERNATE) in postmenopausal women: A Phase III Study

  • Description: This study has several objectives. One purpose is to determine whether neoadjuvant endocrine therapy with fulvestrant or the combination of anastrozole and fulvestrant, is better than anastrozole when given before surgery to shrink the cancer and stop it from growing. Anastrozole inhibits tumor growth by reducing the levels of estrogen and has been approved by the Food and Drug Administration (FDA) of the United States for use after surgery for postmenopausal women with estrogen receptor positive breast cancer. It is also considered a standard of care to give anastrozole for a few months before surgery to shrink the tumor. Fulvestrant inhibits tumor cell growth by reducing the levels of estrogen receptor in the tumor cell. It is not approved by the FDA for use in women with early stage breast cancer before or after surgery, but is approved by the FDA for patients with advanced (Stage 4) estrogen receptor positive breast cancer that has spread to other parts of the body. Therefore, fulvestrant alone, and the combination of anastrozole and fulvestrant is the investigational treatment in this study.
  • Contact: Joni Gomes, RN BSN OCN; (212) 824-7076/ 7659

Combination Immunotherapy with Herceptin and the HER2 Vaccine E75 in Low and Intermediate HER2-expressing Breast Cancer Patients to Prevent Recurrence

  • Description: The purpose of this study is to test the HER2/neu peptide (piece of the protein) E75 as a vaccine in combination with Herceptin (trastuzumab) to determine if it can prevent breast cancer recurrence; to look at the immune system's response to the vaccine in combination with Herceptin; to collect information on the vaccine in combination with Herceptin's safety and dosing.
  • Contact: Joni Gomes, RN BSN OCN; (212) 824-7076/ 7659

Phase II Trial of Combination Immunotherapy with Nelipepimut-S + GM-CSF (NeuVax™) and Trastuzumab in High Risk HER2+ Breast Cancer Patients

  • Description: The goal of this clinical research study is to compare if and for how long trastuzumab combined with either NeuVax (nelipepimut-S given with GM-CSF [sargramostim]) or sargramostim can help to control the disease in patients with HER2 positive breast cancer.
  • Contact: Joni Gomes, RN BSN OCN; (212) 824-7076/ 7659

A Randomized Multicenter Phase II Trial to Evaluate the Safety and Immunogenicity of Two Doses of Vaccination with Folate Receptor Alpha peptides with GM-CSF in patients with Triple Negative Breast Cancer

  • Description: The ultimate intent of the vaccine is to prevent disease from recurring. The vaccine is made from protein pieces that are found on ovarian and breast cancers. To enhance the vaccine, the protein pieces are mixed with what is called an adjuvant, which alerts the immune system.  For this study, the adjuvant will be mixed with the vaccine prior to administration.  Another drug to be administered in the course of vaccination is cyclophosphamide.  It will be used at low dose, not to directly affect the cancer but to help enhance immunity.
  • Contact: Joni Gomes, RN BSN OCN; (212) 824-7076/ 7659

A Multi-Centered Randomized Phase II Comparison of Single-Agent Carboplatin versus the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer

  • Description: The purpose of this study is to evaluate the safety and effectiveness of carboplatin compared to the combination of carboplatin and everolimus for the treatment of advanced triple-negative breast cancer (TNBC)
  • Contact: Joni Gomes, RN BSN OCN; (212) 824-7076/ 7659

Comparison of weight loss among early stage breast cancer patients post chemotherapy: nutrition education in combination with weight loss acupuncture vs. nutrition education alone

  • Description: This is a research study for women who have been treated for early stage breast cancer. Studies have shown that overweight women with early stage breast cancer have an increased risk of cancer recurrence and death.  Given the negative consequences of weight gain after diagnosis, this study hopes to identify effective weight management techniques aimed at promoting overall health and long-term survival.  We will examine whether adding weight loss acupuncture to a nutrition education program for weight loss could improve short and long term weight loss among breast cancer survivors after treatment with chemotherapy.
  • Contact: Neha Kumarley, MPH; (212) 824-7659

Comparison in the Change of Proliferation Index between Fulvestrant and Tamoxifen in Cyclin D1 , Estrogen Receptor Breast Cancer

  • Description: Newly diagnosed premenopausal breast cancer patients with ER+ tumors in whom primary surgery is planned at Mount Sinai will be recruited during their initial consultation with surgeons at the Dubin Breast Center. Patients who agree to participate in the study will have their tumor assessed for cyclin D1 by core biopsy. Eligible and interested patients with cyclin D1 positive tumors will undergo screening procedures required to participate in the research study. After informed consent is obtained, patients will be randomized to either an Arm that will receive 20 mg Tamoxifen Orally daily for 21 days or 750 mg Fulvestrant injection once during the 21 day period. A total of 64 patients will be randomized in a 1:1 allocation.
  • Contact: Joni Gomes, RN BSN OCN; (212) 824-7076/ 7659

A Phase I, First in Human, Dose Escalation Trial of MSC2363318A, a Dual p70S6K/Akt Inhibitor, in Subjects with Advanced Malignancies

  • Description: This Phase I, first in human, 2-part nonrandomized, open label, dose finding trial will explore the safety, tolerability, PK, PD, and clinical activity signals of the study drug -MSC2363318A, administered orally once daily as a single agent to subjects with advanced malignancies that may be controlled with p70S6K or Akt inhibition. MSC2363318A administered orally once daily in combination with weekly trastuzumab administered intravenously in subjects with trastuzumab-resistant HER2+ metastatic breast cancer and MSC2363318A administered orally once daily in combination with daily tamoxifen administered orally in subjects with hormone-resistant ER/PgR+ metastatic breast cancer.
  • Contact: Joni Gomes, RN BSN OCN; (212) 824-7076/ 7659

A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

  • Description: To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the invasive disease-free survival (IDFS) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer.
  • Contact: Joni Gomes, RN BSN OCN; (212) 824-7076/ 7659

Contact Us

Dubin Breast Center
The Mount Sinai Hospital
Klingenstein Pavilion
1176 5th Avenue
New York, NY 10029

For Appointments and Information
Tel: 855-TO-DUBIN (863-8246) or

Breast Imaging
Tel: 212-241-3300 option 1

Breast Surgery
Tel: 212-241-3300 option 2

Breast Reconstruction (plastic surgery)
Tel: 212-241-4410

Medical Oncology
Tel: 212-241-3300 option 3

Radiation Oncology
Tel: 212-241-7501

Breast Pathology
Tel: 212-241-7397

Breast Health Resource Program (psychosocial support)
Tel: 212-987-3063