Basket Study for Oligo-metastatic Breast Cancer

NCT05982678 | Recruiting Phase 2

• 1 other identifier: M22BOL
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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 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

HER2-positive Breast Cancer

Keywords

Oligometastatic disease (max 3 lesions)

Outcome Measures

Primary Outcomes (1)

• Complete radiologic response

  Number of patients to achieve radiologic response as defined by RECIST 11 with clearnace of ctDNA

  up to one year after start treatment

Secondary Outcomes (6)

• Number of patients free of progression

  assessed up to 10 years

• Overall Survival

  assessed up to 10 years

• Number of patients with pathological complete response

  assessed immediately after surgery

• Number of patients with metabolic response

  assessed up to 12 months

• Number of patients with metabolic response

  assessed up to 10 years

Study Arms (1)

Trastuzumab-deruxtecan

EXPERIMENTAL

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.

Drug: Trastuzumab deruxtecan

Interventions

Trastuzumab deruxtecan DRUG

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.

Trastuzumab-deruxtecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Daiichi Sankyo: collaborator
• AstraZeneca: collaborator

Study Sites (1)

Antoni van Leeuwenhoek

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Interventions

trastuzumab deruxtecan

Study Officials

• Marleen Kok, MD

  Antoni van Leeuwenhoek

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marleen Kok, MD

CONTACT

+31205129111; m.kok@nki.nl

Robbert-Jan Gielen, MD

CONTACT

+3120512

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 8, 2023
• Study Start: May 2, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2034
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

NL (1)