Trial information
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic Breast Cancer
Status: Completed
Protocol number: M77050
Sponsor: Roche S.p.A. Italy
Company division: Pharmaceutical
Official Scientific Title: A study to evaluate the effect of administration of Herceptin in combination with cisplatin-epirubicin-paclitaxel (PET) on tumor response in metastatic breast cancer patients
Brief summary: This study will evaluate the efficacy and safety of intravenous Herceptin in combination with cisplatin-epirubicin-paclitaxel in patients with HER2/neu-positive metastatic breast cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 28.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: trastuzumab[Herceptin]
Primary outcome: 1. Overall response rate
Key secondary outcomes: 1. Efficacy: Duration of response, survival time, progression-free survival time. Safety: Cardiac safety (as measured by ECG and LVEF), adverse events, laboratory parameters
Inclusion criteria:
- women 18-70 years of age;
- metastatic breast cancer (stage IV);
- HER2/neu-positive;
- measurable disease.
Exclusion criteria:
- previous treatment for metastatic disease;
- congestive heart failure or angina pectoris, even when medically controlled;
- history of heart attack, arrhythmia, or uncontrolled high-risk hypertension;
- history of prior malignancy in last 10 years, other than non-melanoma skin cancer or cervical cancer in situ.
Gender: Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Trial registration date: 03/10/2006
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Italy
