Clinical trial NCT00617942: Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer
Official title: BrUOG-BR-211B q3week Carboplatin With Weekly Abraxane and Trastuzumab As Neoadjuvant Therapy in Resectable and Unresectable HER2+ (Stage IIa-IIIb) Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2008-02-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 \< 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

Primary outcomes:
measure: Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC;
timeFrame: 1 year
Secondary outcomes:
measure: Patients Affected by Toxicities of Regimen During Treatment, Including Grade >2 Neurotoxicity the Incidence of Subclinical and Clinical Cardiac Toxicity
timeFrame: 1 year
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: New Haven
country: United States
facility: Yale Smilow Cancer Center
state: Connecticut
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
city: Providence
country: United States
facility: Roger Williams Medical Center
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island and The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Brown University
name: William Sikov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheng H, Bai Y, Sikov W, Sinclair N, Bossuyt V, Abu-Khalaf MM, Harris LN, Rimm DL. Quantitative measurements of HER2 and phospho-HER2 expression: correlation with pathologic response to neoadjuvant chemotherapy and trastuzumab. BMC Cancer. 2014 May 8;14:326. doi: 10.1186/1471-2407-14-326.