Recruiting

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

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…

ClinicalTrials.gov IDNCT05334459

PhaseNot Applicable

Enrollment40

SponsorAnkara Oncology Research and Training Hospital

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Metastatic Breast Cancer

About this study

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.

Primary outcomes

Survival (5 years follow-up)

Eligibility information

Inclusion Criteria: * Primary breast tumor amenable for complete surgical resection, patients in good physical condition for receiving protocol driven locoregional and systemic treatments and receiving radiotherapy. Exclusion Criteria: * Primary tumor not amenable for complete resection; primary tumor with extended infection, bleeding, or necrosis; patients with poor physical condition which prevents the patient from receiving protocol driven locoregional and systemic treatment; synchronous primary cancer at the contralateral breast; clinically involved contralateral axillary nodes; patients not suitable for adequate follow-up, and failure to give informed consent. Pregnancy and lactation.

Study locations

Lutfi Dogan, Ankara, Turkey (Türkiye)

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.