Hypofractionated RadiotherapyNCT07046195
Optimal Combination of Adjuvant Radiotherapy and Immunotherapy for Breast Cancer
An observational study of Hypofractionated Radiotherapy and Triple Negative Breast Cancer (TNBC), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hypofractionated Radiotherapy, Triple Negative Breast Cancer (TNBC), Immunotherapy
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2024to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Adult, Older adult
Study population: Tripple negative breast cancer patients who require hypofractionated radiotherapy and immunotherapy
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, 51000
About this study
Official title: Clinical Study of the Optimal Combination Mode of Adjuvant Radiotherapy Combined With Immunotherapy for Triple Negative 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.
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 4 months after the end of treatment
Secondary outcomes (6)
ipsilateral breast tumor recurrence
Any ipsilateral chest wall, breast recurrence events during the follow-up period
Measured: From date of enrollment, through study completion, an average of 5 years
Local-regional Recurrence
Any ipsilateral chest wall, breast, regional lymph node recurrence event during the follow-up period
Measured: From date of enrollment, through study completion, an average of 5 years
Distant metastasis
Any distant metastasis during the follow-up period.
Measured: From date of enrollment, through study completion, an average of 5 years
Distant metastasis free survival
The time from the date of randomization of the subject to the earliest occurrence of distant metastases or death
Measured: From date of enrollment, through study completion, an average of 5 years
Disease free survival
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
Measured: From date of enrollment, through study completion, an average of 5 years
Overall Survival
From the date of randomization of the subject to the death of the patient.
Measured: From date of enrollment, through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start11 Dec 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypofractionated RadiotherapyStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046195
- Sponsor's protocol ID
- 2023ZD0502302
- Status last verified
- Apr 2025
- First submitted
- 9 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Optimal Combination Mode of Adjuvant Radiotherapy Combined With Immunotherapy for Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07046195
- Acronym / sponsor ID
- 2023ZD0502302
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Tripple negative breast cancer patients who require hypofractionated radiotherapy and immunotherapy
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
ipsilateral breast tumor recurrence
Time frame: From date of enrollment, through study completion, an average of 5 years
Local-regional Recurrence
Time frame: From date of enrollment, through study completion, an average of 5 years
Distant metastasis
Time frame: From date of enrollment, through study completion, an average of 5 years
Distant metastasis free survival
Time frame: From date of enrollment, through study completion, an average of 5 years
Disease free survival
Time frame: From date of enrollment, through study completion, an average of 5 years
Overall Survival
Time frame: From date of enrollment, through study completion, an average of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Hypofractionated Radiotherapy
Active, not recruitingPhase 1
Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)
Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingPhase 2
Proton Moderately Hypofractionated Radiotherapy in NSCLC Patients Unable to Tolerate Standard Concurrent Chemoradiotherapy
Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
Locally Advanced Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8
Not yet recruitingPhase 2/3
A Randomized Trial of Standard vs. Hypofractionated Accelerated Radiotherapy for Progression in Limited-Stage Small Cell Lung Cancer
Limited Stage Small-Cell Lung Cancer
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypofractionated Radiotherapy and Triple Negative Breast Cancer (TNBC), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade 3-4 adverse reactions (time frame: From enrollment to 4 months after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.