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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
William Sikov, Brown University
ClinicalTrials.gov Identifier:
NCT00617942
First received: February 6, 2008
Last updated: April 21, 2013
Last verified: April 2013

February 6, 2008
April 21, 2013
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00617942 on ClinicalTrials.gov Archive Site
Assess toxicities of regimen during treatment, including grade >2 neurotoxicity the incidence of subclinical and clinical cardiac toxicity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Interventions:
  • Drug: Carboplatin
  • Drug: nab-paclitaxel
  • Drug: trastuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2017
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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00617942
BrUOG-BR-211B
Yes
William Sikov, Brown University
William Sikov
Yale University
Principal Investigator: William Sikov, MD Brown University
Brown University
April 2013

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