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.
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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…
Contacts

Marleen Kok, MD

+31205129111

m.kok@nki.nl

CONTACT

Robbert-Jan Gielen, MD

+3120512

CONTACT