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Phase 2 N=81 Treatment

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

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00148668 ↗
Enrolled (actual)
81
Serious AEs
12.4%
Results posted
Jan 2013
Primary outcome: 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 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Herceptin (Drug); Navelbine (Drug); Taxotere (Drug); Carboplatin (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Eric Winer, MD
Primary completion
Jan 2009

Outcome Measures

OutcomeResultp-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 —

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.

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.

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