Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer

William Sikov MD

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Cohort 1 adjuvant; Drug: Cohort 2 adjuvant; Drug: Cohort 2 neo-adjuvant; Drug: Cohort 1 neo-adjuvant

Study type: Interventional

Funder types: Other

Identifiers

NCT00617942

BrUOG-BR-211B

Details and patient eligibility

About

Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable and unresectable HER2+ (stage IIa-IIIb) breast cancer

Full description

Our goal is to develop an induction chemotherapy regimen that will have a pCR rate above 50% in HER2+ patients without exposing patients to the toxicity of an anthracycline-based regimen. A minimum of 60 evaluable patients will be accrued to the study. We are assuming an observed pCR (or near pCR) rate of 70%. Assuming no more than 10% of patients will be inevaluable for the primary endpoint (pCR), we will have at least 54 evaluable patients. With this number, we will have 90% power, with a 1-sided alpha error of 0.05, to demonstrate a pCR rate exceeding 50% for our novel regimen.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 < or = ULN
• No evidence of metastatic disease Not pregnant or lactating
• No prior systemic therapy for this breast cancer
• Serum Creatinine < 1.5 mg/dl or Creat Cl > 30 ml/min
• Serum ALT < 2.5 x ULN
• ER, PR and HER2 status required
• LVEF (MUGA/echo)WNL
• No baseline > 2 neuropathy
• Hemoglobin > 9.0 gm/dl
• HER2+, defined by IHC 3+ or FISH ratio > 2.0

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Neo-adjuvant cohort 1

Experimental group

Treatment:

Drug: Cohort 1 neo-adjuvant

Neo-adjuvant cohort 2

Experimental group

Treatment:

Drug: Cohort 2 neo-adjuvant

Adjuvant cohort 1

Experimental group

Treatment:

Drug: Cohort 1 adjuvant

Adjuvant cohort 2

Experimental group

Treatment:

Drug: Cohort 2 adjuvant