Basket Study for Oligo-metastatic Breast Cancer

The study will include patients with HER2-positive breast cancer and 1- 3 distant metastatic lesions, all amenable for curative intervention. Patients will be stratified by prior therapy and ER expression. In the initial baskets patients with be treated with trastuzumab-deruxtecan. Patients are treated with T-DXd 5.4mg/kg on a three weekly (21 day) basis, with the goal of 16 cycles leading to a treatment period of year, including local treatment. The first 8 cycles of T-DXd are administered neo-adjuvant, and 8 cycles adjuvant, after completion of local treatment. The proposed M22BOL trial is

Trial Details

NCT ID
NCT05982678
Phase
PHASE2
Sponsor
The Netherlands Cancer Institute
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Trastuzumab deruxtecan
Locations (sample)
  • Amsterdam, Netherlands|52.37403,4.88969

Key Eligibility Criteria

  • Histologic proof of infiltrating HER2-positive breast cancer (as determined by IHC 3+ and/or amplification by ISH)\[8\]
  • Histologic or cytologic proof of breast cancer metastases (at least one lesion)
  • Histologic determination of level of ER-expression
  • Oligo-metastatic disease as determined by standard of care diagnostics. The number of total individual distant metastases is limited to five, eithe…

For full eligibility, visit ClinicalTrials.gov.

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