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

A randomized, 3 arm, multicentre, phase III study to evaluate the efficacy and the safety of T-DM1 combined with pertuzumab or T-DM1 combined with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab plus taxane, as first line treatment in HER2- positive progressive or recurrent locally advanced or metastatic breast cancer (MBC)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221448

Enrollment

1092

Registered

2011-04-27

Start date

2011-04-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

investigational material(s) Generic name etc : RG3502 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material :

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
- PFS - Safety RECIST version 1.1, NCI CTCAE(v. 4.0)	—

Secondary

Measure	Time frame
- Overall Response Rate (ORR) - Overall Survival Rate (OS) - 1-year Survival Rate - Clinical Benefit Rate - Time to Treatment Failure (TTF) - Duration of Response (DR) RECIST version 1.1, NCI CTCAE(v. 4.0)	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026