Phase III clinical trial of RG3502 and RG1273 for breast cancer patients

Phase 3

• Conditions: Patients who have HER2 -positive (IHC 3+ and /or ISH+) progressive or recurrent locally advanced or previously untreated metastatic breast cancer

• Registration Number: JPRN-jRCT2080221448
• Lead Sponsor: Chugai Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 1092

Inclusion Criteria

HER2-positive breast cancer
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Patients with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent
- Patients must have measurable and/or non-measurable disease which must be evaluable per RECIST 1.1
- ECOG Performance Status 0 or 1
- Adequate organ function as determined by laboratory results

Exclusion Criteria

- History of prior (or any) chemotherapy for metastatic breast cancer
- An interval of < 6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis
- Hormone therapy < 7 days prior to randomization
- Trastuzumab therapy < 21 days prior to randomization
- Prior trastuzumab-DM1 or pertuzumab therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified