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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by William Sikov, Brown University.
Recruitment status was:  Active, not recruiting
Yale University
Information provided by (Responsible Party):
William Sikov, Brown University Identifier:
First received: February 6, 2008
Last updated: July 15, 2014
Last verified: July 2014
February 6, 2008
July 15, 2014
February 2008
August 2012   (Final data collection date for primary outcome measure)
To determine the clinical and pathologic response rates, particularly the pCR/near pCR rate, observed following treatment with q3week carboplatin, weekly Abraxane and weekly trastuzumab in resectable and unresectable LABC; [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00617942 on Archive Site
Assess toxicities of regimen during treatment, including grade >2 neurotoxicity the incidence of subclinical and clinical cardiac toxicity [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer
BrUOG-BR-211B q3week Carboplatin With Weekly Abraxane and Trastuzumab As Neoadjuvant Therapy in Resectable and Unresectable HER2+ (Stage IIa-IIIb) Breast Cancer
Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable and unresectable HER2+ (stage IIa-IIIb) breast cancer
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.
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Carboplatin
    Carboplatin AUC 6
    Other Name: Abraxane (nab-paclitaxel), Herceptin (trastuzumab)
  • Drug: nab-paclitaxel
    Abraxane 100 mg/m2
    Other Name: Abraxane (nab-paclitaxel)
  • Drug: trastuzumab
    trastuzumab 2 mg/kg
    Other Name: Herceptin (trastuzumab)
Experimental: Phase II
Drug: Carboplatin, Abraxane, Trastuzumab
  • Drug: Carboplatin
  • Drug: nab-paclitaxel
  • Drug: trastuzumab
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
December 2014
August 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
William Sikov, Brown University
William Sikov
Yale University
Principal Investigator: William Sikov, MD Brown University
Brown University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP