Local Therapy for ER/PR-positive Oligometastatic Breast Cancer

Summary

Randomized phase 2 trial to evaluate the efficacy of local therapy for oligometastasis from ER/PR-positive breast cancer. The study hypothesis is that local therapy in addition to systemic therapy improves progression-free survival in comparison with systemic therapy alone.

Eligibility

Inclusion Criteria:

* Female sex
* ≥ 18 years of age
* Histologically confirmed invasive breast cancer, with oligometastatic disease defined as one of the following criteria: 1) One to four bone lesions; 2) One to four lung and/ or hepatic lesions; 3) Distant metastasis limited to ipsilateral cervical lymph nodes; 4) Distant metastasis limited to contralateral axillary lymph nodes
* Oligometastatic sites amenable to treatment with a local therapy modality, including surgical resection, stereotactic radiotherapy, or radiofrequency ablation
* Estrogen receptor-positive and/ or progesterone receptor-positive breast cancer
* Partial response or stable disease after at least six months of systemic therapy for breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Measurable or non-measuble disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Life expectancy of at least 12 weeks
* For women in childbearing age, negative pregnancy test until 21 days before the date of study enrollment.
* Signed informed consent form
* Disposition and aptitude to fulfill the study protocol during the study duration

Exclusion Criteria:

* HER2-positive breast cancer
* Progressive disease during the last systemic treatment received for metastatic disease
* Previous local therapy for distant metastasis
* Current or previous history of severe diseases, such as clinically relevant heart failure, acute myocardium infarction in the last six months, chronic obstructive lung disease, HIV infection, chronic active hepatitis B or C infection, current serious uncontrolled infections or other severe diseases that may impact patients' expected survival)
* Current or previous history of other invasive malignancy within the last five years, excluding non-melanoma skin cancer

Conditions2

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