Assessing safety of combining radiotherapy with new systemic therapies for breast cancer
Official title: Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer
Run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT06197581 · Data updated 2026-11-12
This study is testing if it's safe to give new breast cancer treatments together with radiation therapy to see if they can work well together for patients who need both.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 148 (estimated) |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | trastuzumab, immunotherapy, Radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 12, 2024 |
| Main results expected | January 15, 2026 |
| Study ends | January 15, 2027 |
| Registry record updated | August 21, 2024 |
| Trial ID | NCT06197581 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-70 with a pathologically confirmed diagnosis of breast cancer who require radiotherapy and are eligible for specific systemic therapies.
✕Probably not a fit
Patients with male breast cancer, severe comorbidities, or those allergic to the study medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety of administering concurrent radiotherapy alongside novel systemic therapies for breast cancer, including agents like capecitabine and HER2 inhibitors. It aims to determine whether these treatments can be safely synchronized or if one should be paused during the other. The research is motivated by previous findings suggesting a synergistic effect between certain molecular therapies and radiotherapy. The study will involve patients who require radiotherapy and are eligible for systemic therapy as per clinical guidelines.
Why it matters
Potential benefit: If successful, this study could enhance treatment protocols for breast cancer, potentially improving patient outcomes and safety during concurrent therapies.
How similar studies have gone: While there is evidence of synergy between certain therapies and radiotherapy, this specific approach is novel and requires further investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: ECOG 0-2. Aged 18-70 years old. Pathologically diagnosed as breast cancer. Need to receive radiotherapy according to guidelines. Radiotherapy target volume included chest wall/breast with or without lymph node regions. Need to receive one of the following therapies according to guidelines, capetabine, CDK4/6 inhibitor, PARP inhibitor , ICIs , HER2 inhibitors. Exclusion Criteria: Male breast cancer. Allergy to the upper medicines before. Will receive trastuzumab alone during and/or after radiotherapy. With severe other disease.
Where it's running
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Cancer Hospital ,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Yirui Zhai, MD — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study coordinator: Yirui Zhai, MD
- Email: januarywind@163.com
- Phone: +86-10-87788058
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.