Phase 2 N=60 Treatment

Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00617942 ↗

Enrolled (actual)

Serious AEs

21.3%

Results posted

Aug 2017

Primary outcome: Primary: Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC; — 12; 13 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cohort 1 neo-adjuvant (Drug); Cohort 2 neo-adjuvant (Drug); Cohort 1 adjuvant (Drug); Cohort 2 adjuvant (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: William Sikov MD
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC;	12; 13	—
SECONDARY Patients Affected by Toxicities of Regimen During Treatment, Including Grade >2 Neurotoxicity the Incidence of Subclinical and Clinical Cardiac Toxicity	37; 23; 29; 19	—

Summary

Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable and unresectable HER2+ (stage IIa-IIIb) breast cancer

Eligibility Criteria

Inclusion Criteria

Histologically documented adenocarcinoma of the breast
ANC > 1000 cells
Female; age > 18; Zubrod PS 0-1
Platelets > 100,000
Stage IIA-IIIB disease
Total bilirubin 30 ml/min
Serum ALT 2 neuropathy
Hemoglobin > 9.0 gm/dl
HER2+, defined by IHC 3+ or FISH ratio > 2.0

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00617942). 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.