Carboplatin, Abraxane, Avastin as Neoadjuvant Therapy for Her2-Negative Breast Cancer

• Status: Completed
• Trial end date: 2014-05-15
• Target enrollment: 0
• Participant gender: Female

Summary

In the MDACC/BrUOG neoadjuvant trial with weekly paclitaxel followed by Fluorouracil Plus Doxorubicin and Cyclophosphamide (FAC), the pathologic complete response (pCR) rate in HER2(-) patients was 20%. The investigators' goal is to develop an induction chemotherapy regimen that will have a pCR rate above 30% in patients with HER2(-) disease. Based on a 1-sided 95% confidence interval using normal approximation with an expected pCR rate of at least 35%, approximately 28 patients are required for each cohort. With an assumed pCR rate of at least 35%, the investigators will have approximately 70% statistical power to conclude, with 90% certainty, that the pCR rate with the novel regimen exceeds 20%. The study will accrue approximately 60 patients in two cohorts with an inevaluable rate that does not exceed 10%.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: William Sikov; William Sikov MD
• Collaborator: Yale University
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Paclitaxel

Criteria

Eligibility criteria

Inclusion criteria:

• Histologically documented adenocarcinoma of the breast

• ANC > 1000 cells

• Female; age > 18

• Zubrod PS 0-1

• Platelets > 100,000

• Stage IIA-IIIB disease

• Total bilirubin < 1.5 ULN

• No evidence of any metastatic disease

• Serum Creatinine < 1.5 gm/dl

• No prior systemic therapy for breast cancer or Creat Cl > 30 ml/min

• Not pregnant or lactating

• Serum ALT < 2.0 ULN

• ER, PR and HER2 status required

• LVEF (MUGA/echo WNL)

• No baseline > 2 neuropathy

• Urine protein: creat ratio < 1.0

• HER2-negative - either IHC 0-1+ or FISH ratio < 2.0

• Hemoglobin > 9 gm/dl

• (FISH testing is required for all HER2 2-3+ tumors by IHC)

Exclusion criteria:

• No Histologically documented adenocarcinoma of the breast

• No-ANC > 1000 cells

• Female; age < 18

• Zubrod PS > 0-1

• Platelets < 100,000

• Stage IV disease

• Total bilirubin > 1.5 ULN

• metastatic disease

• Serum Creatinine > 1.5 gm/dl

• prior systemic therapy for breast cancer or Creat Cl > 30 ml/min

• pregnant or lactating

• Serum ALT > 2.0 ULN baseline > 2 neuropathy

• Urine protein: creat ratio >1.0

• HER2-positive

• Hemoglobin < 9 gm/dl