Eribulin in HER2 Negative Metastatic BrCa

NCT ID: NCT01827787

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-05-31

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 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.

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 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: HR+/HER2-

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Group Type: EXPERIMENTAL

Eribulin

Intervention Type: DRUG

Cohort 2: TNBC

Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle

Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.

Group Type: EXPERIMENTAL

Eribulin

Intervention Type: DRUG

Interventions

Eribulin

Intervention Type: DRUG

Other Intervention Names

E7389; Halaven; ER-086526; NSC-707389

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Erica Mayer, MD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erica Mayer, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Eastern Maine Medical Center

Bangor, Maine, United States

Dana-Farber Cancer Institute at Faulkner Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

DF/BWCC at Milford Regional Cancer Center

Milford, Massachusetts, United States

South Shore Hospital

Weymouth, Massachusetts, United States

Dana-Farber/New Hampshire Oncology-Hematology

Londonderry, New Hampshire, United States

Countries

United States

References

Filho OM, Giobbie-Hurder A, Lin NU, Faggen M, Come S, Openshaw T, Constantine M, Walsh J, Freedman RA, Schneider B, Burstein HJ, Mayer EL. A dynamic portrait of adverse events for breast cancer patients: results from a phase II clinical trial of eribulin in advanced HER2-negative breast cancer. Breast Cancer Res Treat. 2021 Jan;185(1):135-144. doi: 10.1007/s10549-020-05928-4. Epub 2020 Oct 6.

Reference Type: DERIVED

PMID: 33025482 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

13-077

Identifier Type: -

Identifier Source: org_study_id