Phase 2 N=74 Randomized Treatment

Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00068341 ↗

Enrolled (actual)

Serious AEs

27.0%

Results posted

Mar 2017

Primary outcome: Primary: Evaluate the Objective Response Rate of Patients Treated With Taxotere/Carboplatin With or Without Herceptin Preoperatively. — 13; 8; 33; 54 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: trastuzumab (Biological); carboplatin (Drug); docetaxel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Jonsson Comprehensive Cancer Center
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Evaluate the Objective Response Rate of Patients Treated With Taxotere/Carboplatin With or Without Herceptin Preoperatively.	13; 8; 33; 54; 13; 11	—
SECONDARY Clinical Tumor Response by Physical Exam and Imaging Studies	8; 5; 18; 7; 7; 21	—
SECONDARY Tumor Response Assessment	6; 1; 12	—
SECONDARY Clinico-histologic Predictors of pCR (Pathologic Complete Response)	11; 14; 8; 38; 14; 24	—
SECONDARY Pathologic Nodal Status	9; 4; 21; 6; 11; 23	—

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer. PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.

Eligibility Criteria

Inclusion Criteria

Confirmed infiltrating adenocarcinoma of the breast
Primary breast cancer > 5cm, or skin/chest wall involvement, any N, without evidence of metastasis.
No prior radiation to the involved breast
ECOG (Electrocochleography) performance status 0-2
Age 18 years to 80 years
Absolute Neutrophil count > 1500 cell/μl, platelet count > 100000 cells/μl and hemoglobin > 9 g/dl
All liver function tests grade 2

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Data sourced from ClinicalTrials.gov (NCT00068341). 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.