Breast Cancer Clinical Trial

Eribulin in HER2 Negative Metastatic BrCa

Summary

Improvements in outcomes with metastatic breast cancer (MBC) have been observed in the last 30 years, however, overall prognosis remains poor with median survival of 2 to 3 years. Long term complete responses are observed only for a minority of MBC patients (2-5%) and MBC remains an incurable disease for most patients. Eribulin is a chemotherapy approved by the US FDA in November of 2010 to treat patients with MBC who have received at least two prior chemotherapy regimens. In this research study, the investigators are looking to see how well eribulin helps participants with MBC in an earlier-line setting. Eribulin works by interfering with cancer cell division, growth and spread.

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Full Description

Based on positive results in heavily pre-treated MBC patients, eribulin is being studied as first-line or second-line chemotherapy treatment. This is a non-randomized, open label study with participants enrolled in one of two cohorts: Cohort 1. Hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative (HR+/HER2-) or Cohort 2: Triple negative breast cancer (TNBC) meaning HR-negative/HER2-negative (HR-/HER2-). HR- means progesterone receptor-negative (PR-) and estrogen receptor-negative (ER-). Beyond efficacy as measured primarily by response to treatment, investigators will evaluate safety, tolerability and quality of life. In particular, it is hypothesized that eribulin may have lower rates of neuropathy, a common side effect of many of the major chemotherapeutics with activity in MBC. The investigators will 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 explore if gene markers may indicate increased sensitivity to the nerve effects of eribulin.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

83

Study ID:

NCT01827787

Recruitment Status:

Completed

Sponsor:

Dana-Farber Cancer Institute

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There are 6 Locations for this study

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Eastern Maine Medical Center
Bangor Maine, 04402, United States
Dana-Farber Cancer Institute at Faulkner Hospital
Boston Massachusetts, 02130, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
DF/BWCC at Milford Regional Cancer Center
Milford Massachusetts, 01757, United States
South Shore Hospital
Weymouth Massachusetts, 02190, United States
Dana-Farber/New Hampshire Oncology-Hematology
Londonderry New Hampshire, 03053, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

83

Study ID:

NCT01827787

Recruitment Status:

Completed

Sponsor:


Dana-Farber Cancer Institute

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