Phase 2
Completed N=49
Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00258960 ↗Enrolled (actual)
49
Serious AEs
33.3%
Results posted
Jul 2019
Primary outcomePrimary: Objective Response Rate (ORR) — 33 Participants
Summary
Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
33 | — |
| SECONDARY Time to Progression (TTP) |
12 | — |
| SECONDARY Time to Treatment Failure (TTF) |
9.7 | — |
| SECONDARY Response Duration |
9.51 | — |
| SECONDARY Overall Survival (OS) |
34.2 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must sign an informed consent before of specific procedures of clinical trial.
- Patients with histologically confirmed breast cancer and overexpression of Her2neu.
- Age> 18 years.
- Eastern Cooperative Oncology Group (ECOG) equal or 300 mg/m2 (Doxorubicin) or > 600 mg/m2 (Epirubicin)
Data sourced from ClinicalTrials.gov (NCT00258960). 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.