Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer

Sponsor
Karolinska University Hospital
Study ID
NCT05900206
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab deruxtecan — DRUG
    Experimental drug. Provided in 100mg vials. IV infusion.
  • Docetaxel — DRUG
    Active comparator. IV infusion.
  • Paclitaxel — DRUG
    Active comparator. IV infusion.
  • Carboplatin — DRUG
    Active comparator. IV infusion.
  • Trastuzumab — DRUG
    Active comparator. IV infusion.
  • Pertuzumab — DRUG
    Active comparator. IV infusion.
  • Ribociclib — DRUG
    Experimental drug. Tablets.
  • Letrozole — DRUG
    Experimental drug. Tablets.
  • Epirubicin — DRUG
    Active comparator. IV infusion.
  • Cyclophosphamide — DRUG
    Active comparator. IV infusion.

Study Details

The goal of this clinical trial is to compare trastuzumab deruxtecan (T-DXd) to standard preoperative treatment in patients with non-metastatic HER2-positive breast cancer. The main questions it aims to answer are: * is T-DXd more effective than standard preoperative treatment? * are there markers in the tumor or blood of patients with HER2-positive breast cancer that can help us predict response to treatment? Participants will be divided into two groups, where one group will be treated with three courses of T-DXd and the other group will be treated with three courses standard of care treatment. Thereafter, further treatment will be decided by the tumor's molecular subtype.

Key Dates

Start date
Oct 26, 2023
Status verified
Aug 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2032

Study Design

Enrollment
370 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: T-DXd (cycles 1-3)
    Trastuzumab Deruxtecan, administered every three weeks for three courses. Further treatment is decided by the intrinsic molecular (PAM50) subtype of the tumor.
  • Active Comparator: Standard treatment (TCHP or PCHP; cycles 1-3)
    TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab) or PCHP (Paclitaxel, Carboplatin, Trastuzumab, Pertuzumab), administered every three weeks for three courses. Further treatment is decided by the intrinsic molecular (PAM50) subtype of the tumor.
  • Other: ER-positive and Luminal (cycles 4-6)
    Ribociclib, letrozole, trastuzumab, pertuzumab
  • Other: ER-negative and Luminal, or Basal-like, or Normal-like (cycles 4-6)
    Epirubicin and Cyclophosphamide in case of no complete radiologic response after the initial three courses. In case of complete radiologic response, treatment from cycles 1-3 (T-DXd or TCHP/PCHP) will continue instead for three more courses.
  • Other: HER2-enriched (cycles 4-6)
    The same treatment with T-DXd or TCHP/PCHP administered every three weeks for three more courses will continue from cycles 1-3

Primary Outcome Measure

Pathologic complete response (pCR) of HER2-enriched patients [ Time Frame: Binary outcome which will be assessed at the time of surgery after six cycles of treatment (each cycle is 21 days) ]

Central Contacts

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