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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Cohort 2 adjuvant; Drug: Cohort 1 neo-adjuvant; Drug: Cohort 2 neo-adjuvant; Drug: Cohort 1 adjuvant

• Registration Number: NCT00617942
• Lead Sponsor: William Sikov MD

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-06
• Study First Submitted QC: 2008-02-15
• Study First Posted: 2008-02-18
• Primary Completion: 2012-08
• Results First Submitted: 2015-11-14
• Study Completion: 2015-12
• Results First Submitted QC: 2017-07-24
• Results First Posted: 2017-08-22
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant cohort 2	Cohort 2 adjuvant	-
Neo-adjuvant cohort 1	Cohort 1 neo-adjuvant	-
Neo-adjuvant cohort 2	Cohort 2 neo-adjuvant	-
Adjuvant cohort 1	Cohort 1 adjuvant	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC;	1 year	These numbers represent patients with a RCB score of zero (0). RCB stands for residual cancer burden.

Secondary Outcome Measures

Name	Time	Method
Patients Affected by Toxicities of Regimen During Treatment, Including Grade >2 Neurotoxicity the Incidence of Subclinical and Clinical Cardiac Toxicity	1 year	Please note that these events represent toxicities that were experienced during treatment, but that does not mean that all toxicities were indeed deemed related to study treatment.

Trial Locations

Locations (5)

Women and Infants Hospital; 🇺🇸 Providence, Rhode Island, United States

City of Hope; 🇺🇸 Duarte, California, United States

Rhode Island and The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States

Roger Williams Medical Center; 🇺🇸 Providence, Rhode Island, United States

Yale Smilow Cancer Center; 🇺🇸 New Haven, Connecticut, United States