Optimal Combination of Adjuvant Radiotherapy and Immunotherapy for Breast Cancer

Last updated: June 23, 2025
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cancer Treatment

Vaccines

Chemotherapy

Treatment

N/A

Clinical Study ID

NCT07046195
2023ZD0502302
  • Ages 18-65
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-65 years;

  2. Triple negative invasive breast cancer, with immunohistochemistry confirming thatthe primary lesion was ER- or ER<10% and weakly expressed, PR-, HER 2-;

  3. Patients who had surgery after neoadjuvant immunotherapy, and required ahypofractionated radiotherapy regimen of whole breast/chest wall ± regional lymphnodes ±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 conservingpatients; For patients with a stage of T4 or N3c, it is up to the radiationoncologist to decide whether to proceed with sequential bolsing of locoregionallesions;

  4. Patients received adjuvant immunotherapy after neoadjuvant immunotherapy, and thedrugs used for postoperative immune maintenance were the immunodrugs used in theneoadjuvant treatment stage;

  5. Patients who have not received neoadjuvant immunotherapy and require 1 year ofadjuvant immunotherapy and hypofractionated intensity-modulated radiotherapy forwhole breast/chest wall ± regional lymph nodes ± tumor beds in the postoperativeadjuvant stage.

Exclusion

Exclusion Criteria:

  1. Failure to complete the course of radiotherapy as planned

  2. Concomitant contralateral breast cancer or second primary malignancy (except basalcell carcinoma of the skin and carcinoma in situ of the cervix);

  3. Previous history of thoracic radiotherapy;

  4. Serious heart, lung, liver, kidney, hematopoietic and nervous system diseases,mental diseases;

  5. Concomitant autoimmune diseases such as scleroderma or active lupus erythematosus;pregnant and lactating patients;

  6. Patients with prior immunotherapy-related grade 3-4 toxicities during theneoadjuvant immunotherapy phase

Study Design

Total Participants: 250
Study Start date:
December 11, 2024
Estimated Completion Date:
July 31, 2028

Connect with a study center

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

    Guangzhou, 51000
    China

    Site Not Available

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