Eribulin in HER2 Negative Metastatic BrCa

Status: Recruiting
Phase: Phase 2
Diagnosis: Breast: Metastatic
NCT ID: NCT01827787 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-077

 

This research study is a phase II clinical trial. Phase II clinical trials test the effectiveness of a drug to learn whether the drug works in treating a specific cancer. Eribulin is a chemotherapy approved by the US FDA in November of 2010 to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens. It works by interfering with cancer cell division, growth and spread. In this research study, the investigators are looking to see how well Eribulin helps participants with metastatic breast cancer as a first-line or second-line chemotherapy treatment. The investigators also would like to learn about the side-effects that participants experience with this medication, in particular, neuropathy. Neuropathy is a condition in which the nerves are affected, leading to numbness or tingling of the fingers and toes. The investigators would like to study the effect Eribulin has on the nerves through regular questionnaires that ask about any nerve-related symptoms. The investigators also plan to send blood samples to determine if gene markers may indicate increased sensitivity to the nerve effects of Eribulin.

 

Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Dana Farber Cancer Institute at Faulkner Hospital, Dana Farber Cancer Institute at Milford, New Hampshire Oncology-Hematology, DF/BWCC at South Shore Hospital

Overall PI:
Nadine Tung, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:
Erica Mayer, MD, Dana-Farber Cancer Institute
Michael Constantine, M.D., Dana Farber Cancer Institute at Milford Hosptial
Frederick Briccetti, M.D., Dana Farber Cancer Institute at Londonderry Hospital
Meredith Fagen, MD, Dana Faber Cancer Insitute at South Shore Hospital

Contacts:
Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478

Eligibility Criteria

Inclusion Criteria: - Histologically or cytologically proven invasive breast cancer, locally recurrent or metastatic, with at least one measureable lesion according to RECIST v1.1 - Hormone receptor positive or hormone receptor negative HER2-negative disease - Up to one prior line of chemotherapy for advanced disease is allowed (discontinued at least 14 days prior to initiation of protocol therapy) - Prior bevacizumab in the neo/adjuvant or metastatic setting is acceptable - No limit on prior lines of endocrine therapy, but must be discontinued at least 7 days prior to initiation of protocol therapy - Must have completed any prior radiotherapy at least 2 weeks prior to initiation of protocol therapy - Must have recovered from reversible effects of prior therapies to no more than grade 1 toxicity, with the exception of alopecia - Agree to use adequate contraception for the duration of study participation Exclusion Criteria: - Pregnant or breastfeeding - Prior treatment with eribulin - Prior malignancy other than carcinoma in situ of the cervix or nonmelanoma skin cancer unless diagnosed and definitively treated at least 3 years before enrollment in this study - Clinically significant cardiovascular impairment - Active brain metastases or unevaluated neurologic symptoms suggestive of brain metastases - Pulmonary dysfunction requiring the use of oxygen - Prior organ allograft requiring immunosuppression - HIV positive on combination antiretroviral therapy - Pre-existing grade 3 or 4 neuropathy - Hypersensitivity to halichondrin B or halichondrin B chemical derivative - Uncontrolled intercurrent illness - Inability to read in English
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