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Chemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer

NCT04733118 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 393

Last updated 2026-04-29

No results posted yet for this study

Summary

This is a multicenter, open-label, single-arm, one-stage, phase II study to assess the efficacy of a chemotherapy-free pathological complete response (pCR)-guided strategy with trastuzumab and pertuzumab (given as a subcutaneous fixed-dose combination) and T-DM1, for patients with previously untreated HER2-positive early breast cancer.

Conditions

  • Early Breast Cancer

Interventions

DRUG

Trastuzumab and Pertuzumab (FDC SC) and T-DM1

Patients will receive Trastuzumab and Pertuzumab as a subcutaneous fixed-dose combination (PH FDC SC) (± ET depending on HR status) for 8 3-week cycles, on day 1 only. ET will consist of letrozole for post-menopausal women or tamoxifen ± ovarian function suppression (OFS) for pre-menopausal women administered continuously. Men will receive tamoxifen. After completing neoadjuvant therapy, a final breast MRI will be performed 2 weeks prior to surgery. Surgery will be performed within 4 weeks after completion of the last cycle of PH FDC SC. Adjuvant systemic therapy will start within 4 weeks from surgery. There will be three different cohorts depending on pathological report: * Cohort A: PH FDC SC ± ET for 10 additional 3-week cycles * Cohort B: T-DM1 ± ET for 10 cycles * Cohort C: T-DM1 ± ET for 10 cycles, with possibility of physician's choice chemotherapy before adjuvant T-DM1.

Sponsors & Collaborators

Principal Investigators

  • Antonio Llombart-Cussac, MD · Arnau de Vilanova Hospital, Valencia (Spain)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-05
Primary Completion
2027-03-31
Completion
2028-03-31

Countries

  • Bulgaria
  • Germany
  • Hungary
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT04733118 on ClinicalTrials.gov