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

NCT ID: NCT00232479

Last Updated: 2012-08-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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arm 1

single arm study evaluating the efficacy of neoadjuvant taxotere, herceptin and carboplatin given in a dose dense fashion

Group Type EXPERIMENTAL

trastuzumab, docetaxel and carboplatin in dose dense regimen

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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herceptin, taxotere and carboplatin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Metastatic disease
* Low ejection fraction
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aventis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Judith Hurley

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith Hurley

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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SCCC 2004-064

Identifier Type: -

Identifier Source: org_study_id