Dose Dense Carboplatin, Taxotere and Herceptin As Primary Systemic Therapy in Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Judith Hurley, University of Miami
ClinicalTrials.gov Identifier:
NCT00232479
First received: September 30, 2005
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.


Condition Intervention Phase
Breast Cancer
Drug: trastuzumab, docetaxel and carboplatin in dose dense regimen
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Dose Dense Carboplatin and Taxotere With Herceptin As Primary Systemic Therapy in Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Number of Patients With Pathologic Complete Response (pCR) [ Time Frame: determined at the time of surgery which is approximately 16 weeks from the beginning of treatment ] [ Designated as safety issue: No ]
    pCR is defined as the absence of invasive tumor from the surgical specimen of breast and axilla which is obtained after the chemotherapy regimen has been delivered.


Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: from the first dose of chemotherapy until surgery which was approximately 16 weeks. ] [ Designated as safety issue: Yes ]
    the number of patients with grade 4 (severe) toxicities and or hospitalizations were measured to assess safety and tolerability


Enrollment: 48
Study Start Date: September 2005
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: arm 1
single arm study evaluating the efficacy of neoadjuvant taxotere, herceptin and carboplatin given in a dose dense fashion
Drug: trastuzumab, docetaxel and carboplatin in dose dense regimen
trastuzumab 4 mg/kg day 1 and then 2 mg/kg/week x 11, carboplatin 6 mg AUC Day 1, 15, 29, 43, docetaxel 75 mg/meter squared Days 1, 15, 29, 43, neulasta 6 mg Day 2, 16, 30, 44
Other Name: herceptin, taxotere and carboplatin

Detailed Description:

Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HER-2 overexpressing breast cancer
  • Clinical stage 2-3B
  • Normal ejection fraction

Exclusion Criteria:

  • Metastatic disease
  • Low ejection fraction
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00232479

Locations
United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Aventis Pharmaceuticals
Investigators
Principal Investigator: Judith Hurley University of Miami
  More Information

No publications provided

Responsible Party: Judith Hurley, MD, University of Miami
ClinicalTrials.gov Identifier: NCT00232479     History of Changes
Other Study ID Numbers: SCCC 2004-064
Study First Received: September 30, 2005
Results First Received: June 12, 2012
Last Updated: July 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Carboplatin
Docetaxel
Trastuzumab
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014