NCT04419181

Feasibility of Chemotherapy De-escalation in Early-Stage HER2 Positive Breast Cancer

A Feasibility Study of De-escalation of Chemotherapy in Patients With Early-Stage HER2 Positive Breast Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this research study is to find out if de-escalation of chemotherapy before surgery followed by a selective escalation of adjuvant targeted therapies are efficacious and tolerable in early-stage HER2 positive breast cancer.

Detailed description

Assess the feasibility of four cycles of neoadjuvant Docetaxel Carboplatin Trastuzumab and Pertuzumab (TCHP) in women with early-stage (local/locally advanced) HER2+ breast cancer with a selective escalation of targeted HER2 directed therapy in the high risk group in the adjuvant setting. Participants with any residual disease after four cycles of TCHP will receive Trastuzumab Emtansine (TDM1) plus Pertuzumab while those with complete pathological response will receive Trastuzumab in the adjuvant settings.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Dose: 75 mg/m2 q3w
DRUG	Carboplatin	Dose: area under the concentration-time curve \[AUC\] 6 q3w
DRUG	Trastuzumab	Dose: 8-mg/kg loading dose, 6-mg/kg maintenance dose q3w
DRUG	Pertuzumab	Dose: 840-mg loading dose, 420-mg maintenance dose q3w
DRUG	Trastuzumab emtansine	Dose: 3.6mg/kg q3w

Timeline

• Start date: 2025-08-11
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2020-06-05
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study