NCT07046195Active, not recruiting
Optimal Combination of Adjuvant Radiotherapy and Immunotherapy for Breast Cancer
Clinical Study of the Optimal Combination Mode of Adjuvant Radiotherapy Combined With Immunotherapy for Triple Negative Breast Cancer
Source: ClinicalTrials.gov · Last updated 1 Jul 2025
Brief summary (registry, in English)
Postoperative radiotherapy is a conventional treatment for breast cancer patients with a high risk of recurrence, such as those with regional lymph node metastasis, especially TNBC. However, the optimal mode of treatment for the combination of radiotherapy and immunotherapy has not yet been determined, especially in the adjuvant treatment phase. There is still a lack of validation and high-grade evidence on the safety and synergistic efficacy of radiotherapy-immunotherapy combinations. In this study, we aimed to compare the safety and preliminary efficacy of hypofractionated radiotherapy and concurrent immunotherapy with those of hypofractionated radiotherapy and sequential immunotherapy in the postoperative adjuvant stage through prospective real-world studies for TNBC patients, and focused on verifying the incidence of adverse reactions in radiotherapy and immunotherapy in the adjuvant stage, so as to find out the optimal combination mode of postoperative radiotherapy combined with immunotherapy, further reduce the distant metastasis of TNBC patients under the premise of ensuring safety, and improve long-term survival.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 9 Jun 2025
- Start date
- 11 Dec 2024
- Primary completion date
- Jul 2027
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07046195
What you commit to
- Study type: Observational
- Planned participants: 250
- From 11 Dec 2024 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant contralateral breast cancer or second primary malignancy (except basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Previous history of thoracic radiotherapy;
- Concomitant autoimmune diseases such as scleroderma or active lupus erythematosus; pregnant and lactating patients;
- Patients with prior immunotherapy-related grade 3-4 toxicities during the neoadjuvant immunotherapy phase
Other illness
- Failure to complete the course of radiotherapy as planned
- Serious heart, lung, liver, kidney, hematopoietic and nervous system diseases, mental diseases;
Who the study is looking for
- Age 18-65 years;
- Triple negative invasive breast cancer, with immunohistochemistry confirming that the primary lesion was ER- or ER\<10% and weakly expressed, PR-, HER 2-;
- Patients who had surgery after neoadjuvant immunotherapy, and required a hypofractionated radiotherapy regimen of whole breast/chest wall ± regional lymph nodes ±tumor bed: whole breast/chest wall ± regional lymph nodes DT 40.05Gy/15F; Sequential dose increase of DT 2.9 Gy\*3F for tumor bed in breast conserving patients; For patients with a stage of T4 or N3c, it is up to the radiation oncologist to decide whether to proceed with sequential bolsing of locoregional lesions;
- Patients received adjuvant immunotherapy after neoadjuvant immunotherapy, and the drugs used for postoperative immune maintenance were the immunodrugs used in the neoadjuvant treatment stage;
- Patients who have not received neoadjuvant immunotherapy and require 1 year of adjuvant immunotherapy and hypofractionated intensity-modulated radiotherapy for whole breast/chest wall ± regional lymph nodes ± tumor beds in the postoperative adjuvant stage.
Age in the registry: 18 years to 65 years · Sex: Female
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.