Phase 2
N=44
A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00475670 ↗Enrolled (actual)
44
Serious AEs
13.6%
Results posted
Sep 2014
Primary outcome: Primary: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Guidelines — 61.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Trastuzumab (Drug); Taxane (docetaxel or paclitaxel) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Guidelines |
61.0 | — |
| SECONDARY Duration of Response - Percentage of Participants With Progressive Disease or Death |
88.0 | — |
| SECONDARY Duration of Response |
8.0 | — |
| SECONDARY Progression-free Survival (PFS) - Percentage of Participants With Progressive Disease |
87.8 | — |
| SECONDARY Progression-Free Survival |
8.0 | — |
| SECONDARY Percentage of Participants With Treatment Failure |
95.1 | — |
| SECONDARY Time to Treatment Failure |
8.0 | — |
| SECONDARY Percentage of Participants With Clinical Benefit According to RECIST Guidelines |
70.7 | — |
| SECONDARY Overall Survival - Percentage of Participants Who Died |
63.4 | — |
| SECONDARY Overall Survival |
25.0 | — |
Summary
This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without a taxane for the first line treatment of metastatic breast cancer in women who have relapsed at least 12 months after a minimum of 10 months of (neo)adjuvant treatment with Herceptin for HER2-positive early breast cancer.Patients will receive either Herceptin monotherapy (loading dose of 4mg/kg iv, followed by weekly doses of 2mg/kg iv, or 8mg/kg loading dose followed by 3-weekly doses of 6mg/kg)or Herceptin + a taxane (docetaxel 100mg/m2 iv every 3 weeks, or paclitaxel 175mg/m2 iv every 3 weeks or 75mg/m2 every week). The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
Eligibility Criteria
Inclusion Criteria
- at least 10 months of Herceptin treatment for HER2-positive early breast cancer;
- metastatic breast cancer >=12 months after discontinuation of Herceptin;
- measurable disease.
Exclusion Criteria
- previous chemotherapy for metastatic breast cancer;
- brain metastases;
- invasive malignancy other than metastatic breast cancer.
Data sourced from ClinicalTrials.gov (NCT00475670). 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.