Clinical trial NCT01498588
Conditions: Breast Neoplasms Breast Cancer Breast Tumors Cancer of the Breast Neoplasms, Breast Tumors, Breast
Keywords: Breast Neoplasms Breast Cancer Breast Tumors Cancer of the Breast Neoplasms, Breast Tumors, Breast
Sponsor: Emory University
Start date: 2011-11-01; Completion date: 2015-06-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide

Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:

Day 1: Eribulin 1.4mg/m² IV

Day 8: Eribulin 1.4mg/m² IV

Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:

Day 1: Doxorubicin 60mg/m² IV

Day 1: Cyclophosphamide 600mg/m² IV

Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy at the discretion of the investigator.
Interventions: intervention 1: Eribulin intervention 2: Doxorubicin intervention 3: Cyclophosphamide intervention 4: Pegfilgrastim
Intervention descriptions: intervention 1: Patients will receive 4 cycles of neoadjuvant eribulin followed by 4 cycles of dose-dense doxorubicin and cyclophosphamide (AC). intervention 2: Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide intervention 3: Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide intervention 4: Growth factor support (pegfilgrastim) can be given at the discretion of the investigator. Administration of pegfilgrastim is required 24 to 48 hours following administration of dose-dense doxorubicin and cyclophosphamide.

Protocol documents: