The Optimal Radioimmunotherapy Combinations for Advanced TNBC

NCT06735131 | Recruiting Phase 2 DMC

• 1 other identifier: SYSUCC-025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the best combination patterns of radiotherapy and immunotherapy for advanced triple-negative breast cancer (TNBC).

Conditions

Triple-Negative Breast Cancer (TNBC)

Keywords

radiotherapy; immunotherapy; chemotherapy; triple-negative breast cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (5)

• Progression-free survival (PFS)

  Up to 3 years

• Overall survival (OS)

  up to 3 years

• Objective Response Rate

  up to 3 years

• Duration of response

  up to 3 years

• Number of participants with treatment-related adverse events

  up to 3 years

Study Arms (5)

Arm 1: 5Gy × 5 , daily

EXPERIMENTAL

within 4 weeks before the initiation of cycle of toripalimab and chemotherapy

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

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

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

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

Radiation: radiotehrapy 0.5Gy twice-a-day × 2 days, repeat for 4 cycles (total 8Gy); Drug: Toripalimab; Drug: chemotherapy regimen selected by the investigator

Interventions

radiotherapy 5 Gy × 5 fractions, once a day RADIATION

5 Gy × 5 fractions, once a day, beginning on the day within 4 weeks before the initiation of cycle of toripalimab and chemotherapy

Arm 1: 5Gy × 5 , daily

radiotherapy 8 Gy × 5 fractions, once a day RADIATION

8 Gy × 5 fractions, once a day, beginning on the day within 4 weeks before the initiation of cycle of toripalimab and chemotherapy

Arm 2: 8Gy × 5 , daily

radiotherapy 8 Gy × 3 fractions, once every other day RADIATION

8 Gy × 3 fractions, once every other day, beginning on the day within 4 weeks before the initiation of cycle of toripalimab and chemotherapy

Arm 3: 8Gy × 3, every other day

radiotherapy 10 Gy× 3 fractions, once every other day RADIATION

10 Gy × 3 fractions, once every other day, beginning on the day within 4 weeks before the initiation of cycle of toripalimab and chemotherapy

Arm 4: 10Gy × 3, every other day

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)

Arm 5: 0.5Gy twice-a-day × 2 days, repeat for 4 cycles (8 Gy in total)

Toripalimab DRUG

Toripalimab (240 mg IV, d1, Q3W)

Arm 1: 5Gy × 5 , daily; Arm 2: 8Gy × 5 , daily; Arm 3: 8Gy × 3, every other day; Arm 4: 10Gy × 3, every other day; Arm 5: 0.5Gy twice-a-day × 2 days, repeat for 4 cycles (8 Gy in total)

chemotherapy regimen selected by the investigator DRUG

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)

Arm 1: 5Gy × 5 , daily; Arm 2: 8Gy × 5 , daily; Arm 3: 8Gy × 3, every other day; Arm 4: 10Gy × 3, every other day; Arm 5: 0.5Gy twice-a-day × 2 days, repeat for 4 cycles (8 Gy in total)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• West China Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

toripalimab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Shusen Wang, MD

CONTACT

+86-02087342491; wangshs@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 16, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)