Phase 2
N=33
A Study of Herceptin (Trastuzumab)and Biomarkers in Patients With HER2-Positive Metastatic Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00885755 ↗Enrolled (actual)
33
Serious AEs
27.3%
Results posted
Oct 2015
Primary outcome: Primary: Part I: Progression Free Survival (PFS) by Biomarker — NA; NA; 13.963; 1.216 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Standard taxane therapy (Drug); capecitabine [Xeloda] (Drug); trastuzumab [Herceptin] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part I: Progression Free Survival (PFS) by Biomarker |
NA; NA; 13.963; 1.216; 12.649; NA | — |
| PRIMARY Part II: Progression Free Survival (PFS) by Biomarker |
8.148; NA; 3.450; 13.832; 8.115; NA | — |
| PRIMARY Part I: Time to Progression (TTP) by Biomarker |
NA; NA; 13.963; 1.216; 11.335; NA | — |
| PRIMARY Part II: TTP by Biomarker |
8.148; NA; 3.450; 13.832; 8.115; NA | — |
| PRIMARY Part I: Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progrerssive Disease (PD) by Biomarker |
0.0; 25.0; 50.0; 25.0; 0.0; 91.7 | — |
| PRIMARY Part II: Percentage of Participants With a Best Overall Response of CR, PR, SD or PD by Biomarker |
0.0; 0.0; 100.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Part I: TTP in Intent to Treat (ITT) Population |
22.21; 1.22 | — |
| SECONDARY Part I: PFS in ITT Population |
18.60; 1.22 | — |
| SECONDARY Part II: TTP in Intent to Treat (ITT) Population |
5.65; 13.83 | — |
| SECONDARY Part II: PFS in ITT Population |
5.65; 13.83 | — |
| SECONDARY Overall Survival in Per Protocol Population |
36.40 | — |
| SECONDARY Overall Survival in ITT Population |
NA | — |
| SECONDARY Part I and II: Percentage of Participants With a Best Overall Response of CR or PR in ITT Population |
75.0; 20.0; 5.0; 11.1; 88.9; 0.0 | — |
| SECONDARY Part I and II: Percentage of Participants With a Response by Best Overall Response by CR, PR, SD or PD in ITT Population |
5.0; 70.0; 15.0; 5.0; 5.0; 0.0 | — |
Summary
This single arm study will evaluate alterations in molecular marker expression in HER2-positive targeted therapy, and will evaluate the effect of continued treatment with Herceptin and Xeloda beyond progression following initial Herceptin-taxane chemotherapy. Patients who develop progressive disease will receive first-line Herceptin (8mg/kg iv loading dose and 6mg/kg iv every 3 weeks) + taxane therapy. patients who develop progressive disease within 9 weeks of treatment will continue treatment with Herceptin in combination with Xeloda (1000mg/m2 po bid on days 1-14 of each 3-week cycle).Biopsies of tumor tissue will be taken for biomarker and gene profiling evaluation. The anticipated time on study treatment is until disease progression, intolerable side effects or patient choice, and the target sample size is 100 individuals.
Eligibility Criteria
Inclusion Criteria
- female patients, >=18 years of age;
- HER2-positive breast cancer;
- al least one metastatic site amenable for core biopsy;
- left ventricular ejection fraction >50%.
Exclusion Criteria
- prior adjuvant/neoadjuvant Herceptin within past 6 months;
- prior adjuvant taxane therapy within past 12 months;
- use of chemotherapy, immunotherapy or biological anticancer therapy within past 3 weeks;
- known bleeding diatheses.
Data sourced from ClinicalTrials.gov (NCT00885755). 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.