Eribulin in HER2 Negative Metastatic BrCa

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Erica Mayer, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01827787
First received: April 3, 2013
Last updated: May 8, 2014
Last verified: May 2014
  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.


Condition Intervention Phase
Breast Cancer
Drug: Eribulin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Eribulin in Patients With HER2-Negative, Metastatic Breast Cancer: Evaluation of Efficacy, Toxicity and Patient-Reported Outcomes

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Evaluation of Anti-Tumor Activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Progression-Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Progression Free Survival

  • Time to First Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time to First Response

  • Duration of Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Duration of Response

  • Time to First Response and Duration of Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time to first response and duration of response

  • Describe the Adverse Event Profile of Eribulin [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To describe the adverse event (AE) profile of eribulin, according to provider-rated CTCAE v4.0

  • Describe QOL at Baseline and Over Time [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To describe QOL at baseline and over time using the Functional Assessment of Cancer Therapy-Breast (FACT-B)

  • Describe Impact of Neurotoxicity on QOL [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To describe the impact of neurotoxicity on QOL at baseline and over time using the FACT-Neurotoxicity Subscale (FACT-Ntx)

  • Describe Profile of Patient-Reported Symptomatic Toxicities [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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)

  • Compare FACT-B, FACT-Ntx and PRO-CTCAE Toxicity Data with Provider Reported CTCAE Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 90
Study Start Date: June 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hormone Receptor Positive
Eribulin Monotherapy
Drug: Eribulin
Intravenously on Day 1 and 8 of each cycle
Other Name: E7389
Experimental: Triple Negative Breast Cancer
Eribulin Monotherapy
Drug: Eribulin
Intravenously on Day 1 and 8 of each cycle
Other Name: E7389

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01827787

Contacts
Contact: Erica Mayer, MD, MPH 6176322335 emayer@partners.org

Locations
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04402
Contact: Thomas Openshaw, MD         
Contact: Ambie Hayes-Crosby, RN    207-973-4274    ahayescrosby@emhs.org   
Principal Investigator: Thomas Openshaw, MD         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Erica Mayer, MD, MPH    617-632-2335    emayer@partners.org   
Principal Investigator: Erica Mayer, MD, MPH         
Dana-Farber Cancer Institute at Faulkner Hospital Completed
Boston, Massachusetts, United States, 02130
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Nadine Tung, MD    617-667-1962    ntung@bidmc.harvard.edu   
Principal Investigator: Nadine Tung, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Erica Mayer, MD, MPH Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Erica Mayer, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01827787     History of Changes
Other Study ID Numbers: 13-077
Study First Received: April 3, 2013
Last Updated: May 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014