Phase 2
Completed N=69
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer
Source: ClinicalTrials.gov NCT02015676 ↗Enrolled (actual)
69
Serious AEs
37.7%
Results posted
Mar 2015
Primary outcomePrimary: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment — 51.85; 46.30 percentage of participants
Summary
This study will define an optimal chemotherapy dose regimen of Myocet in combination with paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose regimen in patients with metastatic or locally advanced breast cancer and HER2 overexpression. The anticipated time on study treatment is 3-12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment |
51.85; 46.30 | — |
| SECONDARY Time to Disease Progression - Percentage of Participants With an Event |
40.74 | — |
| SECONDARY Time to Disease Progression |
43.3018 | — |
| SECONDARY Time to Treatment Response - Percentage of Participants With an Event |
98.15 | — |
| SECONDARY Time to Treatment Response |
1.87269 | — |
| SECONDARY Duration of Response - Percentage of Participants With an Event |
39.62 | — |
| SECONDARY Duration of Response |
41.1006 | — |
| SECONDARY Time to Therapy Failure - Percentage of Participants With an Event |
81.48 | — |
| SECONDARY Time to Therapy Failure |
24.0821 | — |
| SECONDARY Overall Survival (OS) - Percentage of Participants With an Event |
3.70 | — |
| SECONDARY Overall Survival |
7.6909 | — |
Eligibility Criteria
Inclusion Criteria
- women 18-70 years of age;
- metastatic or locally advanced breast cancer;
- HER2 overexpression;
- >= 1 measurable lesion.
Exclusion Criteria
- prior treatment for advanced breast cancer;
- prior treatment with Herceptin;
- bone or central nervous system metastasis as the only site of disease;
- history of another malignancy (except basal cell skin cancer and cancer in situ of the uterine cervix, and contralateral breast cancer) within 5 years of study.
Data sourced from ClinicalTrials.gov (NCT02015676). 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.