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NCT Number: NCT07046195

Optimal Combination of Adjuvant Radiotherapy and Immunotherapy for Breast Cancer

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.

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Key information

Conditions

Hypofractionated Radiotherapy Breast Diseases Breast Neoplasms Immunotherapy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Cancer (TNBC) Triple Negative Breast Neoplasms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Guangzhou, 51000, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Incidence of grade 3-4 adverse reactions

    Time frame: From enrollment to 4 months after the end of treatment

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

Secondary outcomes

  1. ipsilateral breast tumor recurrence

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

    Any ipsilateral chest wall, breast recurrence events during the follow-up period

  2. Local-regional Recurrence

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

    Any ipsilateral chest wall, breast, regional lymph node recurrence event during the follow-up period

  3. Distant metastasis

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

    Any distant metastasis during the follow-up period.

  4. Distant metastasis free survival

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

    The time from the date of randomization of the subject to the earliest occurrence of distant metastases or death

  5. Disease free survival

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

    The time from the date of randomization of the subject to the time of disease recurrence or death of the patient due to disease progression

  6. Overall Survival

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

    From the date of randomization of the subject to the death of the patient.

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study title

Clinical Study of the Optimal Combination Mode of Adjuvant Radiotherapy Combined With Immunotherapy for Triple Negative Breast Cancer

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 1, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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