Phase 2 Completed N=81 Treatment

Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer

Source: ClinicalTrials.gov NCT00148668 ↗

Enrolled (actual)

Serious AEs

12.4%

Results posted

Jan 2013

Primary outcomePrimary: Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer — 17; 31 percentage of participants

Summary

The purpose of this study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer.

Outcome Measures

Outcome	Result	p-value
PRIMARY Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer	17; 31	—

Eligibility Criteria

Inclusion Criteria

Patients with stage II or III breast cancer
HER-2 positive tumors
Older than 18 years of age
Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to 1.
ANC > 1,500/mm3
Hemoglobin > 9gm/dl
Platelets > 100,000mm3
Creatinine < 2mg/dl
Glucose < 200mg/dl
Bilirubin < 1.5 x ULN

Exclusion Criteria

Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type therapy, navelbine, or platinum-based therapy.
Pregnant or breast-feeding women
Serious illness, or medical or psychiatric condition
Uncontrolled infections
Active or severe cardiovascular or pulmonary disease
Patients with left ventricular ejection fraction < 50%
Peripheral neuropathy of any etiology that exceeds grade 1
Prior history of malignancy
Uncontrolled diabetes

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00148668). 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. Informational only — not medical advice.