Status:
RECRUITING
Basket Study for Oligo-metastatic Breast Cancer
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
Daiichi Sankyo
AstraZeneca
Conditions:
HER2-positive Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 expres...
Detailed Description
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 expres...
Eligibility Criteria
Inclusion
- 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, either in one organ or in 2-5 organ systems. Clustered lymph nodes that can be irradiated with curative intent in a single field are defined as single lesion. Pleuritis carcinomatosa, miliary spread of metastases (even within one organ), or peritoneal spread of metastases rules out oligo-metastatic disease and is not allowed. Initial staging by PET-CT (whole body) and MRI of breast and brain are mandatory, as is MRI liver or spine and pelvis in case of liver or bone metastases respectively.
- In case of recurrent disease, a disease-free interval of 24 months.
- Measurable disease according to RECIST1.1
- Patients must be at least 18 years of age and be able to give written informed consent and comply with study procedures.
- World Health Organization (WHO) performance status 0 or 1
Exclusion
- prior line of therapy for metastatic disease. Exceptions are endocrine therapy or radiation considered to be part of the curative treatment, within 3 months before enrolment
- leptomeningeal disease or central nervous metastases
- clinically relevant obstruction or compression of spinal cord, central nervous, gastro-intestinal or cardiovascular system, that cannot be alleviated before start of treatment.
- other malignancy, unless treated with curative intention and a long-term survival probability of \>95%, including in-situ or pre-malignant lesions.
Key Trial Info
Start Date :
May 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2034
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05982678
Start Date
May 2 2024
End Date
October 1 2034
Last Update
November 26 2025
Active Locations (1)
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1
Antoni van Leeuwenhoek
Amsterdam, Netherlands