Phase 2 N=44 Treatment

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

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00232479 ↗

Enrolled (actual)

Serious AEs

2.2%

Results posted

Aug 2012

Primary outcome: Primary: Number of Patients With Pathologic Complete Response (pCR) — 19 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: trastuzumab, docetaxel and carboplatin in dose dense regimen (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of Miami
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Pathologic Complete Response (pCR)	19	—
SECONDARY Safety and Tolerability	1	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Metastatic disease
Low ejection fraction

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00232479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.