Clinical Trials /

Eribulin in HER2 Negative Metastatic BrCa

NCT01827787

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Eribulin in HER2 Negative Metastatic BrCa
  • Official Title: A Phase 2 Study of Eribulin in Patients With HER2-Negative, Metastatic Breast Cancer: Evaluation of Efficacy, Toxicity and Patient-Reported Outcomes

Clinical Trial IDs

  • ORG STUDY ID: 13-077
  • NCT ID: NCT01827787

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
EribulinE7389, Halaven, ER-086526, NSC-707389Hormone Receptor Positive

Purpose

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.

Detailed Description

      If you are willing to participate in this study you will be asked to undergo some screening
      tests and procedures to confirm your eligibility. Many of these tests and procedures are
      likely to be part of regular cancer care and may be done even if it turns out that you do not
      take part in the research study. If you have had some of these tests or procedures recently,
      they may or may not have to be repeated. The screening tests and procedures will include: a
      medical history, a physical examination and vital signs, performance status, an assessment of
      your tumor, routine blood tests, pregnancy test and an electrocardiogram. If these tests show
      that you are eligible to participate in the research study, you will begin the study
      treatment. If you do not meet the eligibility criteria, you will not be able to participate
      in this research.

      If you take part in this research study, you will be given Eribulin by intravenous infusion
      (by vein). The time to complete a single treatment is 60 minutes. You will receive Eribulin
      on Day 1 and Day 8 of each cycle. In the third week (Day 15) you will not receive any study
      medication. Each complete treatment cycle lasts 3 weeks.

      During all cycles you will have a physical exam and you will be asked questions about your
      general health and specific questions about any problems that you might be having and any
      medications you may be taking.

      At the beginning of cycles 1,2,3 and every other subsequent cycle, you will be asked to
      complete three online questionnaires using a wireless tablet computer provided in the clinic
      where you are being seen. This is a well established method of administering electronic
      questionnaires. No data will be stored on these computers. The data will be transmitted to
      servers where the data will be securely stored. Your data will be submitted using a special
      identification number. You will be given a username and a password. You will be given
      detailed instructions on how to use the computer and how to enter the data. If the wireless
      tablet computer is not working, paper forms will be provided. It will take about 15-30
      minutes to complete. Some questions you will be asked to answer may make you feel
      uncomfortable. You may choose not to answer any questions that make you feel uncomfortable.

      We will assess your tumor by the appropriate imaging modality (e.g., CT scan or MRI) every 9
      weeks.

      About 4 tablespoons of blood will be drawn to measure blood counts, organ function, and for
      other safety reasons. Blood tests will be done on Day 1 and Day 8 of every treatment cycle
      (every three weeks). One additional tube of blood (about 1 teaspoon) will be collected at Day
      1 to be used to better understand the nerve toxicities of chemotherapy and to be used for
      future research on breast cancer.

      You will have a follow-up visit three weeks after stopping study treatment. During that
      visit, you will have a physical exam, as well as an assessment of any side effects and
      current medications. If you continue to have on-going side effects related to your study
      treatment, we will continue to follow you until this side effect resolves. About 4
      tablespoons of blood will be drawn to measure blood counts and organ function. If you stop
      therapy because of a side effect but your cancer is under control, we will continue to follow
      you with scans every 9 weeks until cancer growth is observed.
    

Trial Arms

NameTypeDescriptionInterventions
Hormone Receptor PositiveExperimentalEribulin Monotherapy
  • Eribulin
Triple Negative Breast CancerExperimentalEribulin Monotherapy
  • Eribulin

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Evaluation of Anti-Tumor Activity
Time Frame:2 years
Safety Issue:
Description:To evaluate the antitumor activity of first-line treatment with single-agent eribulin mesylate in subjects with locally recurrent or metastatic HER2-negative breast cancer by determining overall response rate (ORR) (RECIST v1.1) ORR will be estimated separately for the HR+/HER2-and the TNBC monotherapy cohorts.

Secondary Outcome Measures

Measure:Progression-Free Survival
Time Frame:2 years
Safety Issue:
Description:Progression Free Survival
Measure:Time to First Response
Time Frame:2 years
Safety Issue:
Description:Time to First Response
Measure:Duration of Response
Time Frame:2 years
Safety Issue:
Description:Duration of Response
Measure:Time to First Response and Duration of Response
Time Frame:2 years
Safety Issue:
Description:Time to first response and duration of response
Measure:Describe the Adverse Event Profile of Eribulin
Time Frame:2 years
Safety Issue:
Description:To describe the adverse event (AE) profile of eribulin, according to provider-rated CTCAE v4.0
Measure:Describe QOL at Baseline and Over Time
Time Frame:2 years
Safety Issue:
Description:To describe QOL at baseline and over time using the Functional Assessment of Cancer Therapy-Breast (FACT-B)
Measure:Describe Impact of Neurotoxicity on QOL
Time Frame:2 years
Safety Issue:
Description:To describe the impact of neurotoxicity on QOL at baseline and over time using the FACT-Neurotoxicity Subscale (FACT-Ntx)
Measure:Describe Profile of Patient-Reported Symptomatic Toxicities
Time Frame:2 years
Safety Issue:
Description:To describe the profile of patient-reported symptomatic toxicities experienced by patients receiving treatment with eribulin using the Patient Reported Outcome (PRO) Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Measure:Compare FACT-B, FACT-Ntx and PRO-CTCAE Toxicity Data with Provider Reported CTCAE Toxicity
Time Frame:2 years
Safety Issue:
Description:To compare FACT-B, FACT-Ntx and PRO-CTCAE toxicity data with provider-reported CTCAE toxicity to determine degree of concordance or divergence for each class of toxicity

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Dana-Farber Cancer Institute

Last Updated

January 30, 2018