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

NCT05334459 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2022-04-26

No results posted yet for this 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.

Conditions

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.

Sponsors & Collaborators

  • Ankara Oncology Research and Training Hospital

    lead NETWORK

Principal Investigators

  • Serdar Ozbas, Prof · Endocrine and Breast Surgeon-Ankara

  • Atilla Soran, Prof · Magee-Womens Hospital,University of Pittsburgh Medical Center

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-03-01
Completion
2028-03-31

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05334459 on ClinicalTrials.gov