Radiotherapy for patients with oligometastatic breast cancer
Systemic Therapy With or Without Local Radiotherapy for Extracranial Oligometastatic Breast Cancer
This study is testing whether adding radiotherapy to standard treatment can help people with oligometastatic breast cancer live longer and control their disease better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | ChineseAMS |
| Locations | 2 sites (Beijing, Beijing and 1 other locations) |
| Trial ID | NCT04646564 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of adding radiotherapy to standard systemic therapy for patients with extracranial oligometastatic breast cancer. Participants will be randomly assigned to receive either standard systemic therapy alone or systemic therapy combined with radiotherapy. The study aims to assess survival rates, local control of the disease, and the associated toxicities of the treatment. Patients will be monitored during and after the treatment to evaluate the efficacy and side effects of the radiotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with newly diagnosed or metachronous extracranial oligometastatic breast cancer and a limited number of lesions.
Not a fit: Patients with central nervous system metastases or those requiring palliative radiotherapy for symptom relief may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival and quality of life for patients with oligometastatic breast cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches, suggesting that local radiotherapy can enhance outcomes for patients with oligometastatic disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-70 years old * ECOG performance status 0-2. * Newly-diagnosed or metachronous extracranial oligometastatic diseases confirmed by pathology or imaging, with or without locoregional disease (biopsy of metastasis is preferred). * Total number of locoregional and metastatic lesions of 1-5 , the maximum diameter of lesions ≤5 cm and at least one lesion could be evaluated by RECIST1.1. * Have received or plan to receive systemic therapy. * All lesions could be safely treated by radiotherapy. * Life expectancy \> 6 months. * Have adequate organ function. Exclusion Criteria: * Have metastases in the central nervous system. * have indications for palliative radiotherapy to reduce symptoms, such as pain, bleeding, obstruction, and pending fractures caused by the tumor. * Have moderate/severe liver dysfunction (Child Pugh B or C) from liver metastases, . * Malignant pleural effusion * Unable to tolerate radiotherapy due to serious comorbidity * Have received prior radiotherapy for target area * Pregnant or lactating women
Where this trial is running
Beijing, Beijing and 1 other locations
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing, China (Recruiting)
- Wei-Fang Yang — Tai Zhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Shu-lian Wang, M.D — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study coordinator: Shu-lian Wang, M.D
- Email: wangsl@cicams.ac.cn
- Phone: 8610-87788803
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.