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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Survival — 5 years follow-up
  Phase I study to evaluate feasibility (overall and diseas free survival) of this curative intent treatment approach to patients presenting with dnMBC with oligometastatic disease.

Trial sites (1)

Other trials for the same condition