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Preoperative Radiotherapy and Systemic Therapy Following Surgery in 'de Novo' Metastatic Breast Cancer
Sponsor: Ankara Oncology Research and Training Hospital
Summary
Locoregional (LRT) of the primary tumor in de-novo metastatic breast cancer (dnMBC) is no longer only a surgical challenge, but more the final decision of a multidisciplinary tumor board including medical oncologists, radiation oncologists and surgical oncologists. It is no longer only a question of locoregional control but rather a wider issue of improving overall survival (OS), due to the possible biological link between primary tumor and metastases. A multimodal approach, including LRT with curative intent should be considered for selected dnMBC patients, especially for the subset of bone-only metastatic ones.
Official title: Preoperative Radiotherapy and Systemic Therapy Following Surgery in 'de Novo' Metastatic Breast Cancer (Protocol MF22-01; Intervention Systemic Treatment METastasis-ISTMET)
Key Details
Gender
FEMALE
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
40
Start Date
2022-03-01
Completion Date
2028-03-31
Last Updated
2022-04-26
Healthy Volunteers
No
Conditions
Interventions
radiotherapy
Oligometastatic disease (defined here as 5 or fewer sites of metastatic disease involving 3 or fewer organ systems) * Primary tumor biopsy, Metastatic site biopsy (Bone, liver, etc) (if there is, based on institutional practice) o ER / PR /Her2 /Ki67 study) * Collection of CTC. * Radiotherapy (RT) to the primary breast tumor (Hypo fractionated) * All patients will receive the standard of care treatment with CDK4/6 inhibitor + AI for 6 months (at least 26 weeks). o Denosumab, Biphosphonate for bone metastasis * RT to metastatic side (if visible). Continue Systemic therapy * 12 months, patients will have LRT surgery (BCS/mastectomy + LN evaluation; SLNB+ALND) + RT (based on the institutional practice). Collect CTC and ER/PR/Her 2 in the final specimen * ST will be continued until progression and/or unmanageable toxicity. * Radiologic evaluation every 3-6-month based on institutional practice.
Locations (1)
Lutfi Dogan
Ankara, Turkey (Türkiye)