Assessing safety of combining radiotherapy with new systemic therapies for breast cancer
Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | trastuzumab, immunotherapy, Radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06197581 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with male breast cancer, severe comorbidities, or those allergic to the study medications may not benefit from this study.
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 performed: While there is evidence of synergy between certain therapies and radiotherapy, this specific approach is novel and requires further investigation.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
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.