Triple-Negative Breast Cancer (TNBC)Phase 2NCT06735131
The Optimal Radioimmunotherapy Combinations for Advanced TNBC
A Phase 2 study testing radiotherapy 5 Gy × 5 fractions, once a day, radiotherapy 8 Gy × 5 fractions, once a day and radiotherapy 8 Gy × 3 fractions, once every other day in people with Triple-Negative Breast Cancer (TNBC), run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to explore the best combination patterns of radiotherapy and immunotherapy for advanced triple-negative breast cancer (TNBC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Triple-Negative Breast Cancer (TNBC)
- What is being tested?
- radiotherapy 5 Gy × 5 fractions, once a day, radiotherapy 8 Gy × 5 fractions, once a day and radiotherapy 8 Gy × 3 fractions, once every other day
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2024to Jan 2027
- Phase
- Phase 2
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Inoperable locally advanced/metastatic triple-negative breast cancer (defined as ER and PR <1%; and HER2 negative as IHC 0 or IHC 1+, or IHC 2+ but negative upon fluorescence in situ hybridization (FISH) testing). Patients with ER/PR ≤10% and deemed unsuitable for endocrine therapy by the investigator are also eligible.
- No prior chemotherapy for advanced/metastatic disease.
- ECOG PS score of 0 or 1.
- Presence of 1 to 5 tumor lesions suitable for radiotherapy (individual lesion size between 0.5 and 5 cm, not limited to 1 to 2 organs).
- At least one measurable lesion outside the radiation field that can be evaluated.
- Suitable to receive one of the chemotherapy regimens chosen by the investigator: nab-paclitaxel or gemcitabine + carboplatin.
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- Patients with brain metastases are allowed if they do not require local therapy at enrollment or if the metastatic lesion is treated with the assigned radiotherapy regimen.
- Patients who have previously received PD-1/PD-L1 therapy for early-stage disease are allowed to enroll.
- Able to provide tumor tissue sections or agree to tumor biopsy during the screening period.
- Adequate organ and bone marrow function, with specific requirements:
- Hematology: Neutrophil count (ANC) ≥1.5×10^9/L; Platelet count (PLT) ≥90×10^9/L; Hemoglobin (Hb) ≥90 g/L; No blood product transfusion (including red blood cell and platelet products, etc.) or growth factor (including colony-stimulating factors, interleukins, and erythropoietin, etc.) support treatment within 2 weeks prior to examination.
- Liver function: Serum total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5×ULN (for patients with liver metastases: ALT and AST ≤5×ULN).
- Renal function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance >60 mL/min.
Who cannot join
- Received platinum-containing regimens during the adjuvant/neoadjuvant therapy phase, and the interval from the last treatment to recurrence/metastasis is less than 6 months.
- Have received radiotherapy within 12 weeks prior to enrollment, unless the radiotherapy was for adjuvant purposes and there are lesions outside the previously irradiated field.
- Extensive tumor metastasis with surrounding normal tissues that cannot tolerate radiotherapy damage.
- Significant third-space fluid retention (e.g., ascites, pleural effusion, pericardial effusion).
- Require long-term systemic corticosteroid treatment.
- Have active autoimmune diseases.
- Have concurrent severe infections.
- Other patients deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Qiufan Zheng, MD, +8602087342491, zhengqf@sysucc.org.cn
wangshs@sysucc.org.cn
About this study
Official title: A Prospective, Multicenter Clinical Trial Exploring the Optimal Combination Strategies of Radiotherapy and Immunotherapy for Advanced Triple-Negative Breast Cancer
This study aims to explore the best combination patterns of radiotherapy and immunotherapy for advanced triple-negative breast cancer (TNBC).
Read the detailed description
Metastatic triple-negative breast cancer (mTNBC) is a particularly aggressive form of breast cancer that poses significant therapeutic challenges. Because mTNBC tumors do not express estrogen receptors (ER), progesterone receptors (PR), or HER2, patients with this subtype cannot receive benefits from endocrine therapy or HER2-targeted treatments, leaving chemotherapy as the main treatment option. However, the effectiveness of traditional chemotherapy drugs is limited and they often come with severe side effects. This leads to short durations of progression-free survival (PFS) and overall survival (OS), and the development of drug resistance, which can cause the cancer to recur and spread.
Recently, the advent of immune checkpoint inhibitors has offered new therapeutic prospects for mTNBC. Inhibitors of PD-1/PD-L1, such as Pembrolizumab, Atezolizumab, and Toripalimab, have demonstrated some effectiveness in clinical trials, especially in patients with PD-L1-positive tumors. Yet, the overall response to immunotherapy remains low, and there is a risk of immune-related adverse events (irAEs), which require vigilant monitoring.
To address the shortcomings of both chemotherapy and immunotherapy, researchers are investigating innovative treatment strategies. These include targeting additional immune checkpoint molecules within the tumor microenvironment, developing novel chemotherapy drugs, and integrating immunotherapy with other treatments like radiotherapy. Local radiotherapy can substantially stimulate the immune system, increasing the antigenicity of cancer cells and enhancing the ability of cytotoxic T lymphocytes to recognize and attack cancer cells.
Although combined radiotherapy and immunotherapy have shown promise in treating other types of cancer, the most effective combination patterns, optimal radiotherapy dosing schedules, and the most suitable patient groups for advanced breast cancer, particularly mTNBC, are not well defined. This study seeks to identify the best combinations of radiotherapy and immunotherapy for advanced breast cancer, with the aim of improving survival rates and setting new standards for treatment.
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Being tested
- radiotherapy 5 Gy × 5 fractions, once a day, radiotherapy 8 Gy × 5 fractions, once a day, radiotherapy 8 Gy × 3 fractions, once every other day, radiotherapy 10 Gy× 3 fractions, once every other day, radiotehrapy 0.5Gy twice-a-day × 2 days, repeat for 4 cycles (total 8Gy)
- Keywords
- radiotherapy, immunotherapy, chemotherapy, triple-negative breast cancer
- 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.
radiotherapy 5 Gy × 5 fractions, once a dayRadiation
5 Gy × 5 fractions, once a day, beginning on the day within 4 weeks before the initiation of cycle of toripalimab and chemotherapy
radiotherapy 8 Gy × 5 fractions, once a dayRadiation
8 Gy × 5 fractions, once a day, beginning on the day within 4 weeks before the initiation of cycle of toripalimab and chemotherapy
radiotherapy 8 Gy × 3 fractions, once every other dayRadiation
8 Gy × 3 fractions, once every other day, beginning on the day within 4 weeks before the initiation of cycle of toripalimab and chemotherapy
radiotherapy 10 Gy× 3 fractions, once every other dayRadiation
10 Gy × 3 fractions, once every other day, beginning on the day within 4 weeks before the initiation of cycle of toripalimab and chemotherapy
radiotehrapy 0.5Gy twice-a-day × 2 days, repeat for 4 cycles (total 8Gy)Radiation
0.5 Gy twice-a-day × 2 days, on the first 2 days of the first 4 cycles of toripalimab and chemotherapy (total 8Gy)
ToripalimabDrug
Toripalimab (240 mg IV, d1, Q3W)
chemotherapy regimen selected by the investigatorDrug
Regimens to be selected from: (1) Nab-paclitaxel (125 mg/m2 IV, days 1, 8, Q3W) (2) Gemcitabine (1000 mg/m² IV, days 1 and 8, Q3W) + carboplatin (AUC=2 IV, days 1 and 8, Q3W)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: 5Gy × 5 , daily | Experimental | within 4 weeks before the initiation of cycle of toripalimab and chemotherapy Receives: Radiation: radiotherapy 5 Gy × 5 fractions, once a day; Drug: Toripalimab; Drug: chemotherapy regimen selected by the investigator |
| Arm 2: 8Gy × 5 , daily | Experimental | within 4 weeks before the initiation of cycle of toripalimab and chemotherapy Receives: Radiation: radiotherapy 8 Gy × 5 fractions, once a day; Drug: Toripalimab; Drug: chemotherapy regimen selected by the investigator |
| Arm 3: 8Gy × 3, every other day | Experimental | within 4 weeks before the initiation of cycle of toripalimab and chemotherapy Receives: Radiation: radiotherapy 8 Gy × 3 fractions, once every other day; Drug: Toripalimab; Drug: chemotherapy regimen selected by the investigator |
| Arm 4: 10Gy × 3, every other day | Experimental | within 4 weeks before the initiation of cycle of toripalimab and chemotherapy Receives: Radiation: radiotherapy 10 Gy× 3 fractions, once every other day; Drug: Toripalimab; Drug: chemotherapy regimen selected by the investigator |
| Arm 5: 0.5Gy twice-a-day × 2 days, repeat for 4 cycles (8 Gy in total) | Experimental | on the first 2 days of first 4 cycles of toripalimab and chemotherapy Receives: Radiation: radiotehrapy 0.5Gy twice-a-day × 2 days, repeat for 4 cycles (total 8Gy); Drug: Toripalimab; Drug: chemotherapy regimen selected by the investigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival at 6 months (6m-PFS rate)
Progression-free survival at 6 months (6m-PFS rate) is defined as the percentage of patients who have not experienced disease progression or death due to any cause at the 6-month mark after starting treatment.
Measured: 6 months
Secondary outcomes (5)
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from treatment initiation to disease progression or death from any cause.
Measured: Up to 3 years
Overall survival (OS)
Overall survival (OS) is defined as the time from treatment initiation to death from any cause.
Measured: up to 3 years
Objective Response Rate
Objective response rate (ORR) is defined as the percetage of patients achieving a complete response (CR) or partial response (PR) according to RECIST v.1.1.
Measured: up to 3 years
Duration of response
Duration of response (DOR) is defined as the duration from response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first.
Measured: up to 3 years
Number of participants with treatment-related adverse events
Adverse events are assessed by CTCAE v5.0
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start20 Dec 2024
- Primary completionJul 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast Cancer (TNBC)Studies of the same condition, open and under way.
- More trials run by 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, First Affiliated Hospital Xi'an Jiaotong University
- Responsible party
- Principal investigator, wang shusen, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735131
- Sponsor's protocol ID
- SYSUCC-025
- Status last verified
- May 2025
- First submitted
- 5 Dec 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No