Actively Recruiting
Basket Study for Oligo-metastatic Breast Cancer
Led by The Netherlands Cancer Institute · Updated on 2025-11-26
72
Participants Needed
1
Research Sites
543 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 based on an important knowledge gap for regarding breast cancer patients with 'oligo-metastatic' disease who are usually not included in clinical trials for patients with metastatic disease since loco-regional treatments (radiation, surgery) with curative intent is not allowed in clinical trials for metastatic breast cancer. Moreover, neo-adjuvant trial protocols for early breast cancer exclude patients with distant metastases that can be treated with curative intent. This basket trial evaluates T-DXd for oligo-metastatic breast cancer with the goal to induce deep responses and subsequently long-lasting disease remissions and potentially cure.
CONDITIONS
Official Title
Basket Study for Oligo-metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic proof of infiltrating HER2-positive breast cancer (IHC 3+ and/or amplification by ISH)
- Histologic or cytologic proof of breast cancer metastases (at least one lesion)
- Histologic determination of estrogen receptor (ER) expression level
- Oligo-metastatic disease with up to five total distant metastases in one to five organs
- Clustered lymph nodes irradiable with curative intent in a single field count as a single lesion
- No pleuritis carcinomatosa, miliary spread within an organ, or peritoneal spread allowed
- Initial staging including PET-CT whole body and MRI of breast and brain; MRI of liver or spine and pelvis if liver or bone metastases present
- For recurrent disease, a disease-free interval of at least 24 months
- Measurable disease according to RECIST1.1
- Age 18 years or older, able to give informed consent and comply with study procedures
- WHO performance status 0 or 1
You will not qualify if you...
- Prior therapy for metastatic disease except endocrine therapy or radiation within 3 months before enrollment
- Leptomeningeal disease or central nervous system metastases
- Clinically relevant obstruction or compression of spinal cord, central nervous, gastrointestinal, or cardiovascular system not alleviated before treatment
- Other malignancies unless treated with curative intent and long-term survival probability over 95%, including in-situ or pre-malignant lesions
AI-Screening
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Trial Site Locations
Total: 1 location
1
Antoni van Leeuwenhoek
Amsterdam, Netherlands
Actively Recruiting
Research Team
M
Marleen Kok, MD
CONTACT
R
Robbert-Jan Gielen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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