Basket Study for Oligo-metastatic Breast Cancer
Recruiting
Phase 2
Interventional Study
HER2-positive Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 72 (estimated)
- Sponsor
- The Netherlands Cancer Institute · Other
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About This Trial
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 t…
Trial Locations
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Eligibility Criteria
Inclusion 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 dis…