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Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study

NCT03820063 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 462

Last updated 2025-09-19

No results posted yet for this study

Summary

This is a multicenter, single arm, phase II study evaluating the efficacy of image-guided de-escalating neoadjuvant treatment with paclitaxel, Herceptin® (trastuzumab), carboplatin, and pertuzumab (PTC-Ptz) in stage II-Ill HER2-positive breast cancer.

Conditions

Interventions

DRUG

PTC-Pz

* Paclitaxel 80mg/m2 administered intravenously on day 1 and day 8 * Herceptin® 6mg/kg administered intravenously on day 1 (loading dose 8mg/kg) or Herceptin® administered subcutaneously 600mg on day 1 * Carboplatin AUC 6mg•ml/min administered intravenously on day 1 * Pertuzumab 420mg administered intravenously on day 1 (loading dose 840mg) * Treatment cycles are repeated on day 22 In case of non pCR; Adjuvant T-DM1, 3.6mg/kg Q 22 days, for 14 cycles.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • BOOG Study Center

    collaborator OTHER

  • Borstkanker Onderzoek Groep

    lead NETWORK

Principal Investigators

  • G S Sonke, MD · NKI-AvL

  • A E van Leeuwen- Stok, PhD · BOOG Study Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-27
Primary Completion
2022-11-15
Completion
2032-05-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

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 NCT03820063 on ClinicalTrials.gov