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

NCT04419181 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-10-14

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Ajay Dhakal, MBBS · University of Rochester

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2026-06-01
Completion
2027-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04419181 on ClinicalTrials.gov