COMACHI

Phase 4

Completed

• Conditions: HER2- positive inoperable or recurrent breast cancer

• Registration Number: JPRN-jRCT1080222272
• Lead Sponsor: Chugai Pharmaceutical Co., Ltd.

Brief Summary

The efficacy and safety of P+T+D in Japanese patients were consistent with those of the CLEOPATRA study and we confirmed this treatment as a standard care at 1st line therapy for HER2-positive metastatic breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-30
• Study Completion: 2019-04-25
• Results First Posted: 2019-09-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: Female
• Target Recruitment: 132

Inclusion Criteria

HER2 positive (IHC 3+ or ISH-positive)
- cancer of the breast, with inoperable or recurrent disease, and candidate for chemotherapy
- ECOG performance status 0 or 1.

Exclusion Criteria

- History of anticancer therapy (any EGFR or anti-HER2 agents or vaccines, cytotoxic chemotherapy, or more than one prior hormonal regimen) for inoperable or recurrent breast cancer.
- History of tyrosine kinase/HER family inhibitors for breast cancer, except trastuzumab used in the neoadjuvant or adjuvant setting
- History of systemic breast cancer treatment in the neoadjuvant or adjuvant setting with a disease-free interval from completion of the taxane in the neoadjuvant or adjuvant setting to recurrent diagnosis of < 12 months
- CNS metastases
- Clinically relevant cardiovascular disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified