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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00617942
Recruitment Status : Completed
First Posted : February 18, 2008
Results First Posted : August 22, 2017
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
William Sikov MD, Brown University

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Cohort 1 neo-adjuvant Drug: Cohort 2 neo-adjuvant Drug: Cohort 1 adjuvant Drug: Cohort 2 adjuvant Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2008
Actual Primary Completion Date : August 2012
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Neo-adjuvant cohort 1 Drug: Cohort 1 neo-adjuvant

Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14

Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16

Other Name: Abraxane (nab-paclitaxel), Herceptin (trastuzumab) and carboplatin
Experimental: Neo-adjuvant cohort 2 Drug: Cohort 2 neo-adjuvant
Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
Experimental: Adjuvant cohort 1 Drug: Cohort 1 adjuvant
Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
Experimental: Adjuvant cohort 2 Drug: Cohort 2 adjuvant
Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians


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


Secondary Outcome Measures :
  1. Patients Affected by Toxicities of Regimen During Treatment, Including Grade >2 Neurotoxicity the Incidence of Subclinical and Clinical Cardiac Toxicity [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617942


Locations
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United States, California
City of Hope
Duarte, California, United States, 91010
United States, Connecticut
Yale Smilow Cancer Center
New Haven, Connecticut, United States, 06437
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02903
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908
Rhode Island and The Miriam Hospital
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
William Sikov MD
Yale University
Investigators
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Principal Investigator: William Sikov, MD Brown University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: William Sikov MD, Principle Investigator, Brown University
ClinicalTrials.gov Identifier: NCT00617942    
Other Study ID Numbers: BrUOG-BR-211B
First Posted: February 18, 2008    Key Record Dates
Results First Posted: August 22, 2017
Last Update Posted: June 11, 2020
Last Verified: May 2020
Keywords provided by William Sikov MD, Brown University:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Carboplatin
Trastuzumab
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological