Basket Study for Oligo-metastatic Breast Cancer

Trial Title: Basket Study for Oligo-metastatic Breast Cancer

NCT ID: NCT05982678

Condition: HER2-positive Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Trastuzumab
Trastuzumab deruxtecan

Conditions: Keywords:
Oligometastatic disease (max 3 lesions)

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Trastuzumab deruxtecan
Description: 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.
Arm group label: Trastuzumab-deruxtecan

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.

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 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+

Criteria for 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 disease as determined by standard of care diagnostics. The number of total individual distant metastases is limited to three, either in one organ or in 2-3 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 Criteria: - 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Antoni van Leeuwenhoek

Address:
City: Amsterdam
Country: Netherlands

Status: Recruiting

Contact:
Last name: Rianne Rolfes, MD

Contact backup:
Last name: Ingrid Mandjes, MSc

Investigator:
Last name: Marleen Kok, MD
Email: Principal Investigator

Start date: May 2, 2024

Completion date: October 1, 2034

Lead sponsor:
Agency: The Netherlands Cancer Institute
Agency class: Other

Collaborator:
Agency: Daiichi Sankyo
Agency class: Industry

Collaborator:
Agency: AstraZeneca
Agency class: Industry

Source: The Netherlands Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05982678