Eribulin in HER2 Negative Metastatic BrCa

NCT01827787 | Completed Phase 2 Results DMC

• 1 other identifier: 13-077
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Cancer

Keywords

metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

  Disease was evaluated radiologically at baseline and every 9 weeks on treatment; Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2)

Secondary Outcomes (7)

• Progression-Free Survival (PFS)

  Disease was evaluated radiologically at baseline and every 9 weeks on and off treatment; Median (maximum) PFS follow-up was 12.6 (27.1) months in Cohort 1 and 12.4 (14.3) months in Cohort 2.

• Time to First Response (TTR)

  Disease was evaluated radiologically at baseline and every 9 weeks on treatment; Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2).

• Duration of Overall Response (DOR)

  Disease was evaluated radiologically at baseline and every 9 weeks on and off treatment; Median (maximum) DOR follow-up was 12.6 (27.1) months in Cohort 1 and 12.4 (14.3) months in Cohort 2.

• Percentage of Participants With Grade 1-3 Treatment-Related Peripheral Sensory Neuropathy

  Adverse events were assessed every cycle throughout treatment. Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2)

• Percentage of Participants With Grade 1-3 Treatment-Related Peripheral Motor Neuropathy

  Adverse events were assessed every cycle throughout treatment. Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2)

Study Arms (2)

Cohort 1: HR+/HER2-

EXPERIMENTAL

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.

Drug: Eribulin

Cohort 2: TNBC

EXPERIMENTAL

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.

Drug: Eribulin

Interventions

Eribulin DRUG

Also known as: E7389, Halaven, ER-086526, NSC-707389

Cohort 1: HR+/HER2-; Cohort 2: TNBC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (7)

Eastern Maine Medical Center

Bangor, Maine, 04402, United States

Location

Dana-Farber Cancer Institute at Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

DF/BWCC at Milford Regional Cancer Center

Milford, Massachusetts, 01757, United States

Location

South Shore Hospital

Weymouth, Massachusetts, 02190, United States

Location

Dana-Farber/New Hampshire Oncology-Hematology

Londonderry, New Hampshire, 03053, United States

Location

Related Publications (1)

• 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.

  PMID: 33025482 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The study terminated early with cohort 2: TNBC not meeting target accrual of 45 patients.

Results Point of Contact

• Title: Dr. Erica Mayer
• Organization: Dana-Farber Cancer Institute

Erica_Mayer@dfci.harvard.edu

617-632-2335

Study Officials

• Erica Mayer, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is not a randomized trial rather participants are enrolled based on disease histology. Participants in each arm receive the same treatment regimen.

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 10, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 6, 2024
• Results First Posted: February 6, 2019

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)