Basket Study for Oligo-metastatic Breast Cancer

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 72

Inclusion 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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete radiologic response

Secondary Outcome Measures

Name	Time	Method
Number of patients free of progression;Overall Survival;Number of patients with pathological complete response;Number of patients with metabolic response;Number of patients with metabolic response;Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)