Metastatic Breast Cancer Clinical Trial
Official title:
A Phase II Study of Eribulin Mesylate in Combination With Trastuzumab and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer
In this study, the investigators are testing the effectiveness of the combination of eribulin, pertuzumab and trastuzumab to learn whether this combination of drugs works in treating advanced HER2-positive breast cancer that had received at least one prior treatment previously. At this point, the standard treatment for HER2-positive cancer that has progressed (grown) after a first treatment is chemotherapy combined with therapies that target the HER2 protein (e.g., trastuzumab or lapatinib).
All of the medications that are being tested in this study are approved by the Food and Drug
administration (FDA) for the treatment of metastatic breast cancer. However, the combination
of these three medications in participants has not yet been tested. Eribulin is a
chemotherapy agent that is approved for the treatment of metastatic breast cancer for women
who have previously received at least two prior chemotherapeutic regimens for the treatment
of their metastatic disease. Pertuzumab and trastuzumab are also both approved for the
treatment of advanced HER2-positive breast cancer. Both agents help treat breast cancer by
binding HER2 receptor. However, pertuzumab and trastuzumab bind to different parts of the
HER2 receptor. Another scientific goal of this research study is to perform gene sequencing
(gene tests) on your cancer cells (obtained from biopsies or surgery) and normal tissues
(usually blood). The results of the gene tests will be used to try to develop better ways to
treat and prevent cancers.
After the Phase I run-in, two cohorts based on prior exposure to pertuzumab were evaluated.
The target accrual for Cohort A, without prior pertuzumab, is 56 participants. Using a
two-stage design (n=34 stage 1, n=22 stage 2), there is 90% power assuming 10% Type I error
to determine whether objective response (OR) rate is consistent with the alternative rate of
40% versus the null rate of 24%. There is 57% probability of stopping the trial at stage one
if the true OR rate is 24%. Cohort B, with prior pertuzumab, is evaluated using a single
stage design. There is 91% power to detect an improvement in OR from 10% to 30% with accrual
of 25 participants.
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