Status:
COMPLETED
Eribulin in HER2 Negative Metastatic BrCa
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 r...
Detailed 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 participan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT01827787
Start Date
May 1 2013
End Date
May 1 2016
Last Update
November 6 2024
Active Locations (7)
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1
Eastern Maine Medical Center
Bangor, Maine, United States, 04402
2
Dana-Farber Cancer Institute at Faulkner Hospital
Boston, Massachusetts, United States, 02130
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215