NCT02326974

T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA

The Impact of HER2 Heterogeneity on the Treatment of Early-stage HER2-positive Breast Cancer: a Phase II Study of T-DM1 in Combination With Pertuzumab in the Preoperative Setting

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a combination of drugs as a possible treatment for breast cancer that has tested positive for a protein called HER2. The names of the study interventions involved in this study are: * Trastuzumab emtansine (also called T-DM1) * Pertuzumab

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved T-DM1 for pre-operative use in breast cancer but it has been approved for other uses in breast cancer. The FDA has approved pertuzumab as a pre-operative treatment.

Conditions

• HER-2 Positive Breast Cancer
• Breast Cancer
• Stage II Breast Cancer
• Stage III Breast Cancer

Interventions

Type	Name	Description
DRUG	T-DM1	Neoadjuvant treatment is for a total of 18 weeks.
DRUG	Pertuzumab	Neoadjuvant treatment is for a total of 18 weeks.
PROCEDURE	Excision of tumor/mastectomy	Definitive breast cancer surgery (excision or mastectomy) marks the end of protocol mandated therapy.

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-06-01
• Completion: 2028-01-01
• First posted: 2014-12-30
• Last updated: 2026-04-17
• Results posted: 2021-05-11

Locations

4 sites across 1 country: United States