Weill Cornell Breast Center: List of Open Clinical Trials

Below is a complete list of open clinical trials at the Weill Cornell Breast Center. Click on the study name to read detailed information about the study. To find out more about our clinical trials or to make an appointment at the Breast Center, please call (212) 821-0644.

Supportive Care/Non-Treatment Studies

Study Name Goal of Study Eligibility
Cold Cap Study Preventing hair-loss using the Cold Cap during Taxotere/Cytoxan (TC) -Early Stage Breast Cancer-Begins with TC chemotherapy
Glutamine Study Reducing peripheral neuropathy using glutamine -Grade 1 or above neuropathy-During or after Taxol or Abraxane.
Herceptin Cardiotoxicity Evaluating variations in DNA sequencing (SNPs) on risk of Herceptin-related heart failure -Congestive heart failure-Decline in ejection fraction by 15%
Rakhi Study To study how breast tumors develop blood vessels -Blood samples during treatment-Already underwent surgery

Treatment Studies

Study Name Goal of Study Eligibility
GALENA A vaccine trial: evaluating NeuVax in preventing breast cancer recurrence. -HER2 1+/2+, node positive-Completed standard treatment with surgery, chemo, radiation.
PUMA To study the benefit of two new drugs: Temsirolimus plus Neratinib in metastatic HER2 or TNBC* -No more than 4 prior chemo regimen-Received Herceptin in the past-No concurrent use of hormone therapy
RxSPONDER To study how hormone therapy work with or without chemotherapy in breast cancer -Hormone Positive, HER2 negative-Oncotype <25, 1-3 lymph node positive
BEACON New generation TOPO1 inhibitor NKTR-102 (targets tumor DNA) in recurrent or metastatic breast cancer -Already received 2-5 prior regimens-Already received Taxane, anthracycline, Xeloda, Herceptin (if HER2 +), and hormone therapy (if ER+)
IMMU-132 To study the effectiveness of antibody RS7 attached to SN38, a metabolite of Irinotecan -Already received 1-3 prior regimens-Active disease on CT or MRI
OPTIMER Immunotherapy with OPT-822 in metastatic breast cancer -Stable disease, partial response, or complete response after 1 regimen
ALLIANCE Using Panobinostat (blocks enzymes needed for cell growth) and Letrozole in TNBC* -TNBC* with metastatic disease
177-J591 Using an antibody J591 linked to radioactive molecule 177Lu, to target tumor blood vessels -Metastatic breast cancer-Already received standard therapy
SYNTA Using Ganetespib, a small molecule inhibitor against Hsp90 protein, to stop tumor growth -Previously untreated metastatic, HER2 positive, or TNBC*.
LUX-Breast 1 Using Afatinib (inhibits growth factor receptor) plus Navelbine vs. Herceptin plus Navelbine to stop tumor growth -HER2 positive, metastatic disease-Failed one prior treatment-No prior Navelbine
BKM120 Using BKM120 (inhibit tumor growth and survival by blocking PI3K pathway) with fulvestrant, to enhance cancer cell death -Metastatic, Hormone positive-HER2 negative-Progressed on or after aromatase inhibitor
NCI8264 Using PARP inhibitor ABT-888 (interfere with tumor DNA repair) alone or with Carboplatin -Metastatic BRCA-associated breast cancer
TM Using TM (copper depletion) to prevent recurrence in moderate to high risk patients -Metastatic no active disease-Stage 2 and above TNBC*.

*TNBC = Triple Negative Breast Cancer

Newly Opened Clinical Trial: The BEACON Study (Breast Cancer Outcomes with NKTR-102)

The Weill Cornell Breast Center has recently opened a new clinical trial for women with locally recurrent or metastatic breast cancer that was previously treated with anthracycline, a taxane, and capecitabine. The study sponsor is Nektar Therapeutics. The principal investigator at Weill Cornell is Dr. Tessa Cigler. For more information about the study, please call Marta Cobham, RN at (212) 821-0780 or e-mail Marta at mac2034@med.cornell.edu.

Study Details

The purpose of the study is to test how well women with breast cancer respond to treatment with the experimental drug NKTR-102, compared to standard treatments for breast cancer. The study will also look at the side effects of the study drug and examine how long NKTR-102 stays in a patient’s blood.

Treatment Plan

Study participants will be randomly assigned to one of two study arms:

  • Arm A: participants will receive NKTR-102 via infusion on Day 1 of each 21 day cycle.
  • Arm B: participants will receive one of seven standard of care treatment options available at the study center. The choice of treatment in Arm B will be made after discussions with your doctor. Depending on which drug is chosen by you and your doctor, cycles in Arm B will be either 21 days or 28 days.

The study will take about 38 months to complete. The amount of time on study depends on how well a participant responds to study treatment.

Key Eligibility

  • Women age 18 and older
  • Diagnosed with breast cancer
  • Locally recurrent or metastatic disease
  • Prior therapy must have included anthracycline, a taxane, and Xeloda; must have received a minimum of 2 and maximum of 5 prior cytoxic chemotherapy regimens
  • Detailed eligibility reviewed when you contact the study team

New Clinical Trial: Panobinostat and Letrozole in Treating Metastatic Breast Cancer

N093B: Phase I/II Study of Panobinostat (LBH589) and Letrozole in Patients with Triple Negative Metastatic Breast Cancer

The Weill Cornell Breast Center has recently opened a new clinical trial for people with metastatic breast cancer that is considered “triple negative,” meaning breast cancer that does not express genes for estrogen receptor (ER), progesterone receptor (PR) or HER2. The study sponsor is the Cancer Trials Support Unit (CTSU)/North Central Cancer Treatment Group. The principal investigator at Weill Cornell is Dr. Tessa Cigler. For more information about the study, please call Marta Cobham, RN at (212) 821-0780 or e-mail Marta at mac2034@med.cornell.edu.

Study Details

The purpose of this study is to determine how well people with metastatic breast cancer respond to treatment with the experimental drug panobinostat (also called LBH589) when it is given with letrozole. The study will also evaluate the safety of panobinostat when combined with letrozole.

Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Giving panobinostat together with letrozole may be an effective treatment for breast cancer.

Treatment Plan

Treatment cycles in this study are 28 days. Study participants will take panobinostat (as a tablet by mouth) once daily on Days 1, 3 and 5 in weeks 1-4 and oral letrozole once daily on days 1-28. Treatment cycles repeat every 28 days as long as participants are responding to treatment and tolerating the medications. After completing study therapy, participants will be followed up every 3 to 6 months for up to 5 years.

Key Eligibility

  • Men and women with metastatic breast cancer
  • Cancer must be unresected (has not been removed by surgery)
  • Women must be postmenopausal based on one of the following criteria:
    • Age 60 or older
    • Age 45 or older with last menstrual period ≥12 months before entering the study
    • Bilateral oophorectomy (surgical removal of both ovaries)
  • Men must be age 18 or older
  • Prior therapy:
    • Zero or 1 prior chemotherapy regimens for breast cancer (no more than 1 prior chemotherapy regimen)
    • ≤2 prior aromatase inhibitor regimens (including letrozole)
  • Detailed eligibility reviewed when you contact the study team

ASCO Poster Presentation: ABT-888 (veliparib)+ Carboplatin in Stage IV BRCA-Associated Breast Cancer

Click to enlarge poster

In a poster presentation this week at the American Society of Clinical Oncology (ASCO) conference, researchers presented results from a nationwide study assessing a PARP inhibitor in BRCA-associated breast cancer. Dr. Tessa Cigler is the principal investigator of the study, “ABT-888 (veliparib) in combination with carboplatin in patients with stage IV BRCA-associated breast cancer,” at the Weill Cornell Breast Center.

Platinum and PARP inhibitors have demonstrated activity when used as single agent therapy in BRCA-associated breast cancer. However, there is limited data on using the two classes of medications together.

The study enrolled 22 women with BRCA-associated stage IV breast cancer to compare a combination of carboplatin (platinum-based chemotherapy) and ABT-888 (veliparib, a PARP inhibitor)  vs. single agent ABT-888, when ABT-88 is given every day.

The investigators found that the combination of caboplatin and ABT-888 is feasible, and, in preliminary analysis, the response and clinical benefit rates and duration are encouraging. The authors write that the results provide “justification to proceed with a planned phase II randomized single agent versus combination trial.”

Click here to read the published abstract.