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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: trastuzumab, docetaxel and carboplatin in dose dense regimen

• Registration Number: NCT00232479
• Lead Sponsor: University of Miami

Brief Summary

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

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

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-09-30
• Study First Posted: 2005-10-04
• Primary Completion: 2008-05
• Study Completion: 2008-06
• Results First Submitted: 2012-06-12
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-16
• Last Update Submitted: 2012-07-16
• Results First Posted: 2012-08-21
• Last Update Posted: 2012-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

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

Exclusion Criteria

• Metastatic disease
• Low ejection fraction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
arm 1	trastuzumab, docetaxel and carboplatin in dose dense regimen	single arm study evaluating the efficacy of neoadjuvant taxotere, herceptin and carboplatin given in a dose dense fashion

Primary Outcome Measures

Name	Time	Method
Number of Patients With Pathologic Complete Response (pCR)	determined at the time of surgery which is approximately 16 weeks from the beginning of treatment	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

Name	Time	Method
Safety and Tolerability	from the first dose of chemotherapy until surgery which was approximately 16 weeks.	the number of patients with grade 4 (severe) toxicities and or hospitalizations were measured to assess safety and tolerability

Trial Locations

Locations (1)

Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States