Basket Study for Oligo-metastatic Breast Cancer

Last updated: November 21, 2025
Sponsor: The Netherlands Cancer Institute
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Trastuzumab deruxtecan

Clinical Study ID

NCT05982678
M22BOL
  • Ages > 18
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

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 disease as determined by standard of care diagnostics. The numberof 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 intentin a single field are defined as single lesion. Pleuritis carcinomatosa, miliaryspread of metastases (even within one organ), or peritoneal spread of metastasesrules 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 andpelvis 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 informedconsent and comply with study procedures.

  • World Health Organization (WHO) performance status 0 or 1

Exclusion

Exclusion Criteria:

  • prior line of therapy for metastatic disease. Exceptions are endocrine therapy orradiation considered to be part of the curative treatment, within 3 months beforeenrolment

  • 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 startof treatment.

  • other malignancy, unless treated with curative intention and a long-term survivalprobability of >95%, including in-situ or pre-malignant lesions.

Study Design

Total Participants: 72
Treatment Group(s): 1
Primary Treatment: Trastuzumab deruxtecan
Phase: 2
Study Start date:
May 02, 2024
Estimated Completion Date:
October 01, 2034

Study 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 expression. Given the basket-design of this trial other baskets for oligo-metastatic breast cancer can be added, such as but not limited to other breast cancer subtypes or with other promising drugs.

Baskets for de novo oligo-metastatic disease I. ER+/HER2+ II. ER-/HER2+ Baskets for oligo-metastatic disease after prior chemo/anti-HER2 therapy for primary disease III. ER+/HER2+ IV. ER-/HER2+

Connect with a study center

  • Antoni van Leeuwenhoek

    Amsterdam,
    Netherlands

    Site Not Available

  • Antoni van Leeuwenhoek

    Amsterdam 2759794,
    Netherlands

    Active - Recruiting

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