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Kadcyla 160 mg powder for concentrate for solution for infusion.

DRUG11 trials

Sponsors

F. Hoffmann-La Roche AG, Daiichi Sankyo Inc., Boehringer Ingelheim International GmbH, Rigshospitalet, Seagen Inc.

Conditions

Breast cancerCancerEarly human epidermal growth factor receptor 2 (HER2) positive breast cancerEarly or Locally Advanced/ Inflammatory HER2-Positive Breast CancerHigh-Risk HER2-Positive Breast CancerInvasive Breast CancerMetastatic CancerMetastatic non-clear cell renal cell carcinoma

Phase 1

Phase 2

Phase 3

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ADJUVANT ATEZOLIZUMAB OR PLACEBO AND TRASTUZUMAB EMTANSINE FOR HER2-POSITIVE BREAST CANCER AT HIGH RISK OF RECURRENCE FOLLOWING PREOPERATIVE THERAPY
Active, not recruitingCTIS2023-503568-18-00
F. Hoffmann-La Roche AGEarly human epidermal growth factor receptor 2 (HER2) positive breast cancer
Start: 2021-04-13Target: 377Updated: 2025-08-27
A Phase IIIB, Multinational, Multicenter, Randomized, Open-Label Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administrationin Participants with Early or Locally Advanced/ Inflammatory HER2-Positive Breast Cancer
CompletedCTIS2023-506380-33-00
F. Hoffmann-La Roche AGEarly or Locally Advanced/ Inflammatory HER2-Positive Breast Cancer
Start: 2022-06-28End: 2025-07-03Target: 32Updated: 2025-12-15
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Subjects with High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy
Active, not recruitingCTIS2023-507961-24-00
Daiichi Sankyo Inc.High-Risk HER2-Positive Breast Cancer
Start: 2021-04-19Target: 1124Updated: 2026-01-26
Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer (HER2CLIMB-02)
Active, not recruitingCTIS2024-514733-38-00
Seagen Inc.Unresectable locally-advanced or metastatic HER2+ breast cancer
Start: 2020-11-03Target: 101Updated: 2025-10-20
Atezolizumab, Pertuzumab and Trastuzumab with chemotherapy as neoadjuvant treatment of HER2 positive early high-risk and locally advanced breast cancer (APTneo)
Not yet recruitingCTIS2024-518026-32-00
Fondazione MichelangeloInvasive Breast Cancer
Target: 646Updated: 2025-08-12