NCT04646564

Radiotherapy for Extracranial Oligometastatic Breast Cancer

Recruiting now Phase 3 Last updated 11 January 2022

What this trial tests

Phase 3 trial testing standard of care in Breast Cancer Metastatic in 170 participants. Currently enrolling.

Timeline

6 April 2021

Primary endpoint
30 April 2024

30 April 2026

Quick facts

Lead sponsor	Chinese Academy of Medical Sciences
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	170
Start date	6 April 2021
Primary completion	30 April 2024
Estimated completion	30 April 2026
Sites	2 locations across China

Drugs / interventions tested

• standard of care
• radiotherapy + standard of care

Conditions studied

• Breast Cancer Metastatic — all drugs for Breast Cancer Metastatic →

Sponsor

Chinese Academy of Medical Sciences — full company profile →

Who can join

Adults 18 to 70, female only, with Breast Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

More and more evidence suggests that local radiotherapy can improve the outcomes for patients with oligometastatic disease. The purpose of this study is to assess the impact of radiotherapy, compared with standard systemic therapy alone, on survival, local control and toxicities in patients with extracranial oligometastatic breast cancer. Eligible patients are randomized in a 1:2 ratio between the control arm (standard systemic therapy), and the WLRT arm (standard systemic therapy + radiotherapy). Randomization will be stratified by three factors: visceral metastasis (yes vs.no), number of metastases(≤2 vs. \>2), hormone receptor(positive vs. negative). SBRT technique is preferred. During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients with Oligometastatic Breast Cancer: Study protocol for a randomized controlled multi-national and multi-center clinical trial (OLIGOMA).
   Krug D, Vonthein R, Illen A, Olbrich D, et al · · 2021 · cited 27× · PMID 33912695 · DOI 10.1016/j.ctro.2021.03.012
2. Oligometastasis in breast cancer-current status and treatment options from a radiation oncology perspective.
   Piroth MD, Krug D, Feyer P, Baumann R, et al · · 2022 · cited 22× · PMID 35527272 · DOI 10.1007/s00066-022-01938-x
3. A critical review on oligometastatic disease: a radiation oncologist's perspective.
   Pacifico P, Colciago RR, De Felice F, Boldrini L, et al · · 2022 · cited 12× · PMID 36071292 · DOI 10.1007/s12032-022-01788-8
4. Redefining cancer care: harnessing circulating tumor cells' potential for improved diagnosis and prognosis.
   Janjua D, Chaudhary A, Joshi U, Tripathi T, et al · · 2025 · cited 4× · PMID 40676582 · DOI 10.1186/s12935-025-03883-y
5. Liquid biopsy for guiding breast cancer immunotherapy.
   Fina E, Vitale E, De Summa S, Gadaleta-Caldarola G, et al · · 2025 · cited 3× · PMID 40083311 · DOI 10.1080/1750743x.2025.2479426
6. Management of Musculoskeletal Oligometastatic Disease in Breast Cancer.
   Kon-Liao K, Layme J, Otero López-Lavalle A, Gonzalez MR, et al · · 2025 · PMID 41228369 · DOI 10.3390/cancers17213578
7. The Role of Immunotherapy and Radiation Therapy in the Treatment of Breast Cancer.
   Panse D, Hsieh K, Arons D, Runnels J, et al · · 2025 · PMID 41007771 · DOI 10.3390/biomedicines13092209
8. Definitions of, Advances in, and Treatment Strategies for Breast Cancer Oligometastasis.
   Shien T, Nakamoto S, Fujiwara Y, Kosaka M, et al · · 2025 · PMID 40723288 · DOI 10.3390/cancers17142406