Optimal Combination of Adjuvant Radiotherapy and Immunotherapy for Breast Cancer

NCT07046195 | Active Not Recruiting DMC

• 1 other identifier: 2023ZD0502302
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypofractionated Radiotherapy; Triple Negative Breast Cancer (TNBC); Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Incidence of grade 3-4 adverse reactions

  Treatment-related adverse reactions are defined as those within 120 days of radiotherapy or during and after immunotherapy.

  From enrollment to 4 months after the end of treatment

Secondary Outcomes (6)

• ipsilateral breast tumor recurrence

  From date of enrollment, through study completion, an average of 5 years

• Local-regional Recurrence

  From date of enrollment, through study completion, an average of 5 years

• Distant metastasis

  From date of enrollment, through study completion, an average of 5 years

• Distant metastasis free survival

  From date of enrollment, through study completion, an average of 5 years

• Disease free survival

  From date of enrollment, through study completion, an average of 5 years

Study Arms (2)

Concurrent group

Patients receiving concurrent immunotherapy, that is, at least 1 dose of immunotherapy between 1 week before radiotherapy and the end of radiotherapy

Sequential group

Patients receiving sequential immunotherapy, that is, 1 week before the start of radiotherapy or 2 weeks after the end of radiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tripple negative breast cancer patients who require hypofractionated radiotherapy and immunotherapy

You may qualify if:

• 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.

You may not qualify if:

• Failure to complete the course of radiotherapy as planned
• 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;
• Serious heart, lung, liver, kidney, hematopoietic and nervous system diseases, mental diseases;
• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, 51000, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: July 1, 2025
• Study Start: December 11, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)