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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00617942
First Posted: February 18, 2008
Last Update Posted: August 22, 2017
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.
Collaborator:
Yale University
Information provided by (Responsible Party):
William Sikov, Brown University
  Purpose
Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable and unresectable HER2+ (stage IIa-IIIb) breast cancer

Condition Intervention Phase
Breast Cancer Drug: Cohort 1 neo-adjuvant Drug: Cohort 2 neo-adjuvant Drug: Cohort 1 adjuvant Drug: Cohort 2 adjuvant Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by William Sikov, Brown University:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 60
Study Start Date: February 2008
Study Completion Date: December 2015
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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
Yale University
Investigators
Principal Investigator: William Sikov, MD Brown University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William Sikov, Principle Investigator, Brown University
ClinicalTrials.gov Identifier: NCT00617942     History of Changes
Other Study ID Numbers: BrUOG-BR-211B
First Submitted: February 6, 2008
First Posted: February 18, 2008
Results First Submitted: November 14, 2015
Results First Posted: August 22, 2017
Last Update Posted: August 22, 2017
Last Verified: July 2017

Keywords provided by William Sikov, Brown University:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboplatin
Trastuzumab
Albumin-Bound Paclitaxel
Paclitaxel
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action