Breast Cancer Clinical Trial
Official title:
Phase II Neoadjuvant Trial of Eribulin Followed by Dose Dense Doxorubicin and Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer
Previous studies have shown that chemotherapy has the same effect on treating breast cancer whether you receive it before or after surgery. Receiving chemotherapy before surgery, rather than after surgery, may allow the patient to have less extensive surgery. The purpose of this study is to identify new treatment regimens with better response rates and to find out if the combination of eribulin followed by doxorubicin and cyclophosphamide can shrink the size of the patient's breast tumor and allow you to preserve your breast. Additionally, by receiving chemotherapy before surgery, the investigators will be able to determine if your cancer is responsive to chemotherapy.
This is a phase 2, single-arm, open label study. Patients with Her2-negative, locally
advanced breast cancer will be enrolled on the study prior to receiving neoadjuvant
chemotherapy. Patients will receive 4 cycles of neoadjuvant eribulin followed by 4 cycles of
dose-dense doxorubicin and cyclophosphamide (AC).
All patients will have a baseline biopsy prior to study entry to determine eligibility.
Patients will undergo repeat breast imaging and optional biopsy after completing 4 cycles of
eribulin. Patients will then receive 4 cycles of dose-dense AC. Patients will undergo repeat
breast imaging followed by surgical resection within 30 days of completing last cycle of
chemotherapy. Patients who are not surgical candidates after completion of chemotherapy will
be asked to undergo optional repeat biopsy prior to receiving additional treatment at the
discretion of the investigator. Patients will continue to be followed per standard practice
guideline after surgery
Clinical response will be determined by clinical breast examination prior to each cycle of
chemotherapy and by breast imaging performed at baseline, after completion of eribulin, and
prior to surgery. Pathologic complete response (pCR) will be determined at the time of
surgical resection. Correlative biomarker studies will be performed on tumor samples at the
completion of the clinical trial.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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