Trial of Neoadjuvant THP vs TCHP for HER2-Amplified/Positive Breast Cancer

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Carboplatin — DRUG
  All of the treatment being received by the study participants during the course of the study is standard of care.
• Docetaxel — DRUG
  All of the treatment being received by the study participants during the course of the study is standard of care.
• Trastuzumab (or biosimilar) — DRUG
  All of the treatment being received by the study participants during the course of the study is standard of care.
• Pertuzumab (or biosimilar) — DRUG
  All of the treatment being received by the study participants during the course of the study is standard of care.

Study Details

This is a randomized phase II study to evaluate the pathological complete response (pCR) rate with two neoadjuvant regimens (Docetaxel+Carboplatin+Herceptin/Perjeta and Docetaxel+Herceptin/Perjeta) in HER2 amplified/positive early breast cancer.

Key Dates

Start date

Nov 14, 2025

Status verified

May 2026

Primary completion

Nov 14, 2027

Completion

May 14, 2031

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Arm A
  Carboplatin and docetaxel plus trastuzumab and pertuzumab every 21 days for 6 cycles. Doses and route of administration per institutional standards.
• Other: Arm B
  Docetaxel plus trastuzumab and pertuzumab every 21 days for 6 cycles. Doses and route of administration per institutional standards.

Primary Outcome Measure

Pathologic complete response (pCR) rate in the breast and axilla in the two treatment arms [ Time Frame: At time of breast surgery ]

Central Contacts

• KUCC Navigation
  913-588-3671
  [email protected]

Locations (8)

Find similar trials in Fairway, KS

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