A Phase 2 Study of Eribulin in Patients With HER2-Negative, Metastatic Breast Cancer: Evaluation of Efficacy, Toxicity and Patient-Reported Outcomes
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
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of Anti-Tumor Activity
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.
Erica Mayer, MD, MPH
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Dana-Farber Cancer Institute at Faulkner Hospital||Boston, Massachusetts 02215|