Open label, comparative, randomized, multicenter, study of trastuzumab given with docetaxel versus sequential single agent therapy with trastuzumab followed by docetaxel as first-line treatment for Her2neu+++ metastatic breast cancer patients.

Completed

• Conditions: Breast cancer patients with metastases with HER2neu overexpression (3+ assessed by IHC DAKO HercepTest), previously untreated by chemotherapy, except for neoadjuvant or adjuvant (non-taxane containing) chemotherapy.

• Registration Number: NL-OMON26229
• Lead Sponsor: BOOG

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Histologically documented invasive adenocarcinoma of the breast;

2. Women with previously chemotherapeutically untreated metastatic breast cancer with HER2neu overexpression (defined as 3+ IHC by DAKO HercepTest);

Exclusion Criteria

1. Operable local relapse alone after conservative treatment or contra-lateral tumour, (mastitis or inoperable local recurrence is acceptable for inclusion);

2. Pregnant or lactating women (females of childbearing potential must use adequate contraception);

3. History or presence of brain or leptomeningeal metastases;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival of total sequential versus combined treatment.

Secondary Outcome Measures

Name	Time	Method
Response Rate and Overall Survival.<br>