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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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%.

Key facts

Study ID

NCT00723125

Run by

William Sikov MD

People needed

60

Starts

2008-09-01

Expected to finish

2014-05-15

Last updated by the study team

2021-04-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Bridgeport Hospital — Bridgeport, Connecticut, United States
• Yale Smilow Cancer Center — New Haven, Connecticut, United States
• Rhode Island Hsopital — Providence, Rhode Island, United States
• Women and Infants — Providence, Rhode Island, United States
• The Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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