Preoperative Radiotherapy and Systemic Therapy Following Surgery in 'de Novo' Metastatic Breast Cancer

RecruitingOBSERVATIONAL
Enrollment

40

Participants

Timeline

Start Date

March 1, 2022

Primary Completion Date

March 1, 2023

Study Completion Date

March 31, 2028

Conditions
Metastatic Breast Cancer
Interventions
RADIATION

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."

Trial Locations (1)

Unknown

RECRUITING

Lutfi Dogan, Ankara

All Listed Sponsors
lead

Ankara Oncology Research and Training Hospital

NETWORK