Breast CancerPhase 2NCT07410234
Phase II Exploratory Study of Toripalimab Combined With SBRT in HER2-Negative Breast Cancer Patients With Insensitivity to Neoadjuvant Chemotherapy
A Phase 2 study testing Toripalimab, SBRT and standard neoadjuvant chemotherapy regimens in people with Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of toripalimab combined with radiochemotherapy as perioperative therapy in HER2-negative breast cancer patients insensitive to neoadjuvant chemotherapy. This was a multicohort, single-center exploratory clinical study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Toripalimab, SBRT and standard neoadjuvant chemotherapy regimens
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 21 Feb 2026to 21 Feb 2029
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient voluntarily participates in this study, has signed the informed consent form, with good compliance and willingness to cooperate with follow-up.
- Aged ≥18 years, male or female.
- Histologically confirmed unilateral primary invasive breast cancer, meeting the criteria of cT2-4N0-2M0.
- HER-2 expression negative by immunohistochemistry (IHC); for patients with HER-2 2+ expression, HER-2 gene non-amplification must be confirmed by in situ hybridization (ISH).
- Patients with stable disease (SD) assessed after 2 cycles of neoadjuvant chemotherapy.
- At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
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- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1.
- Expected survival ≥3 months.
- At least one tumor tissue biopsy specimen of the primary tumor obtained during screening must be provided to the central laboratory.
- Function of vital organs meets the following requirements (administration of any blood components or cell growth factors is not allowed within 2 weeks before the start of screening tests):
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
- Platelet count ≥100×10⁹/L;
- Hemoglobin ≥9 g/dL;
- Serum albumin ≥3.0 g/dL;
- Total bilirubin ≤1.5×upper limit of normal (ULN), alanine transaminase (ALT) and/or aspartate transaminase (AST) ≤2.5×ULN;
- Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min (calculated according to the Cockcroft-Gault formula);
- International Normalized Ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN (screening is permitted for patients receiving stable-dose anticoagulant therapy [e.g., low-molecular-weight heparin or warfarin] with INR within the expected therapeutic range for the anticoagulant).
- Female subjects of childbearing potential must undergo a urine or serum pregnancy test within 72 hours prior to the first administration of the study drug with a negative result, and agree to use an effective contraceptive method during the trial and for 6 months after the last dose. Male subjects whose partners are women of childbearing potential must use an effective contraceptive method during the trial and for 6 months after the last dose.
Who cannot join
- A history of invasive malignancy within 5 years prior to signing the informed consent form, except for adequately treated basal/squamous cell skin cancer or carcinoma in situ of the cervix.
- Receipt of any of the following treatments:
- Major surgery or severe trauma within 4 weeks prior to the first dose of study drug;
- Receipt of any non-neoadjuvant anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biotherapy, or tumor embolization) within 12 months prior to the first dose of study drug;
- Previous vaccination with anti-tumor vaccine, or vaccination with live vaccine within 4 weeks prior to the first dose of study drug;
- Requirement for systemic therapy with corticosteroids (>10 mg prednisone equivalent per day) or other immunosuppressants within 2 weeks prior to the first dose of study drug.
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- A current or historical diagnosis of any active autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); excluding vitiligo, or patients with childhood asthma/allergies that have resolved and require no intervention in adulthood. Patients with autoimmune-mediated hypothyroidism on a stable dose of thyroid replacement hormone and patients with type 1 diabetes on a stable dose of insulin are eligible for enrollment.
- A history of immunodeficiency, including positive HIV test results, other acquired/congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
- Uncontrolled clinical cardiac symptoms or diseases, including: (1) heart failure of NYHA Class Ⅱ or higher; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular/ventricular arrhythmias requiring clinical intervention.
- Severe infection (CTCAE Grade >2) within 4 weeks prior to the first dose of study drug (e.g., severe pneumonia, bacteremia, infectious complications requiring hospitalization); active pulmonary inflammation indicated by baseline chest imaging; signs and symptoms of infection requiring oral/intravenous antibiotic therapy within 2 weeks prior to the first dose of study drug (prophylactic antibiotic use is excluded); active pulmonary tuberculosis confirmed by medical history or CT scan, a history of active pulmonary tuberculosis within 1 year prior to enrollment, or a history of active pulmonary tuberculosis more than 1 year prior to enrollment without standard treatment.
- Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or active hepatitis C (positive anti-HCV antibodies with HCV-RNA above the lower limit of detection of the assay).
- Known hypersensitivity or intolerance to toripalimab, chemotherapy drugs used in the study, or their excipients.
- Pregnant or lactating women; subjects of childbearing potential who are unwilling or unable to adopt effective contraceptive measures.
- Current participation in another clinical study or participation within the previous 4 weeks.
- Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase II Exploratory Study of Toripalimab Combined With Stereotactic Body Radiation Therapy in HER2-Negative Breast Cancer Patients With Insensitivity to Neoadjuvant Chemotherapy
The goal of this clinical trial is to evaluate the efficacy and safety of toripalimab combined with radiochemotherapy as perioperative therapy in HER2-negative breast cancer patients insensitive to neoadjuvant chemotherapy.
This was a multicohort, single-center exploratory clinical study. Eligible patients were initially administered standard neoadjuvant chemotherapy (TAC or TE regimen). Efficacy assessment was performed after 2 cycles of neoadjuvant chemotherapy, and only those evaluated as stable disease (SD) were formally enrolled. Enrolled patients were stratified into the HR-positive group and the triple-negative breast cancer (TNBC) group, with each group further divided into 3 arms receiving the following treatments respectively:
- Cohort 1: Continued the original neoadjuvant chemotherapy for 4 cycles, followed by surgical treatment within 5 weeks for eligible patients.
- Cohort 2: Received the original neoadjuvant chemotherapy regimen plus toripalimab for 4 cycles, followed by surgery within 5 weeks; toripalimab monotherapy was continued for an additional 13 cycles postoperatively.
- Cohort 3: Received the original neoadjuvant chemotherapy regimen plus toripalimab for 4 cycles combined with concurrent stereotactic body radiation therapy (SBRT, 25Gy/5f), followed by surgery within 5 weeks; toripalimab monotherapy was continued for an additional 13 cycles postoperatively.
- Conditions
- Breast Cancer
- Being tested
- Toripalimab, SBRT, standard neoadjuvant chemotherapy regimens
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Preoperative: toripalimab, 240mg, IV, D1, Q3W. Preoperative toripalimab contains 4 cycles.
Postoperative: Toripalimab 240mg, IV, D1, Q3W. . Postoperative Toripalimab following surgery within 5 weeks for 13 cycles.
SBRTRadiation
Local radiotherapy: Subjects received concurrent stereotactic body radiotherapy (SBRT，25 Gray in 5 fractions) for the primary lesion, within 5 weeks before the surgery.
standard neoadjuvant chemotherapy regimensDrug
standard neoadjuvant chemotherapy regimens for breast cancer: TAC, TE, etc. T: docetaxel, nab-paclitaxel or paclitaxel. Routine clinical dosage and administration shall be adopted.
A: epirubicin, pirarubicin or doxorubicin. Routine clinical dosage and administration shall be adopted.
C: cyclophosphamide 500 mg/m², IV. Q3W. Dose reduction and treatment delay are permitted; the maximum allowable delay is 3 weeks, calculated from the last administration date. Treatment shall be discontinued if this limit is exceeded.
E: epirubicin. Routine clinical dosage and administration shall be adopted.
| Study group | Role | What they receive |
|---|---|---|
| HR1 | Other | Not described Receives: Drug: standard neoadjuvant chemotherapy regimens |
| HR2 | Experimental | Not described Receives: Drug: Toripalimab; Drug: standard neoadjuvant chemotherapy regimens |
| HR3 | Experimental | Not described Receives: Drug: Toripalimab; Radiation: SBRT; Drug: standard neoadjuvant chemotherapy regimens |
| TNBC1 | Other | Not described Receives: Drug: standard neoadjuvant chemotherapy regimens |
| TNBC2 | Experimental | Not described Receives: Drug: Toripalimab; Drug: standard neoadjuvant chemotherapy regimens |
| TNBC3 | Experimental | Not described Receives: Drug: Toripalimab; Radiation: SBRT; Drug: standard neoadjuvant chemotherapy regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response（pCR）
pCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.
Measured: Up to12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start21 Feb 2026 (estimated)
- Primary completion21 Feb 2028 (estimated)
- Study completion21 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410234
- Sponsor's protocol ID
- TJCIH-TNBCTori-2026
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Exploratory Study of Toripalimab Combined With Stereotactic Body Radiation Therapy in HER2-Negative Breast Cancer Patients With Insensitivity to Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT07410234
- Acronym / sponsor ID
- TJCIH-TNBCTori-2026
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 21 Feb 2026 (estimated)
- Primary completion
- 21 Feb 2028 (estimated)
- Study completion
- 21 Feb 2029 (estimated)
- First posted
- 13 Feb 2026 (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.
The goal of this clinical trial is to evaluate the efficacy and safety of toripalimab combined with radiochemotherapy as perioperative therapy in HER2-negative breast cancer patients insensitive to neoadjuvant chemotherapy.
This was a multicohort, single-center exploratory clinical study. Eligible patients were initially administered standard neoadjuvant chemotherapy (TAC or TE regimen). Efficacy assessment was performed after 2 cycles of neoadjuvant chemotherapy, and only those evaluated as stable disease (SD) were formally enrolled. Enrolled patients were stratified into the HR-positive group and the triple-negative breast cancer (TNBC) group, with each group further divided into 3 arms receiving the following treatments respectively:
- Cohort 1: Continued the original neoadjuvant chemotherapy for 4 cycles, followed by surgical treatment within 5 weeks for eligible patients.
- Cohort 2: Received the original neoadjuvant chemotherapy regimen plus toripalimab for 4 cycles, followed by surgery within 5 weeks; toripalimab monotherapy was continued for an additional 13 cycles postoperatively.
- Cohort 3: Received the original neoadjuvant chemotherapy regimen plus toripalimab for 4 cycles combined with concurrent stereotactic body radiation therapy (SBRT, 25Gy/5f), followed by surgery within 5 weeks; toripalimab monotherapy was continued for an additional 13 cycles postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| HR1 | Other | Drug: standard neoadjuvant chemotherapy regimens |
| HR2 | Experimental | Drug: Toripalimab, Drug: standard neoadjuvant chemotherapy regimens |
| HR3 | Experimental | Drug: Toripalimab, Radiation: SBRT, Drug: standard neoadjuvant chemotherapy regimens |
| TNBC1 | Other | Drug: standard neoadjuvant chemotherapy regimens |
| TNBC2 | Experimental | Drug: Toripalimab, Drug: standard neoadjuvant chemotherapy regimens |
| TNBC3 | Experimental | Drug: Toripalimab, Radiation: SBRT, Drug: standard neoadjuvant chemotherapy regimens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- The patient voluntarily participates in this study, has signed the informed consent form, with good compliance and willingness to cooperate with follow-up.
- Aged ≥18 years, male or female.
- Histologically confirmed unilateral primary invasive breast cancer, meeting the criteria of cT2-4N0-2M0.
- HER-2 expression negative by immunohistochemistry (IHC); for patients with HER-2 2+ expression, HER-2 gene non-amplification must be confirmed by in situ hybridization (ISH).
- Patients with stable disease (SD) assessed after 2 cycles of neoadjuvant chemotherapy.
Key exclusion criteria (15 listed)
- A history of invasive malignancy within 5 years prior to signing the informed consent form, except for adequately treated basal/squamous cell skin cancer or carcinoma in situ of the cervix.
- Receipt of any of the following treatments:
- A current or historical diagnosis of any active autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); excluding vitiligo, or patients with childhood asthma/allergies that have resolved and require no intervention in adulthood. Patients with autoimmune-mediated hypothyroidism on a stable dose of thyroid replacement hormone and patients with type 1 diabetes on a stable dose of insulin are eligible for enrollment.
- A history of immunodeficiency, including positive HIV test results, other acquired/congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
- Uncontrolled clinical cardiac symptoms or diseases, including: (1) heart failure of NYHA Class Ⅱ or higher; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular/ventricular arrhythmias requiring clinical intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ToripalimabPreoperative: toripalimab, 240mg, IV, D1, Q3W. Preoperative toripalimab contains 4 cycles. Postoperative: Toripalimab 240mg, IV, D1, Q3W. . Postoperative Toripalimab following surgery within 5 weeks for 13 cycles. | Drug | HR2, HR3, TNBC2, TNBC3 |
| SBRTLocal radiotherapy: Subjects received concurrent stereotactic body radiotherapy (SBRT，25 Gray in 5 fractions) for the primary lesion, within 5 weeks before the surgery. | Radiation | HR3, TNBC3 |
| standard neoadjuvant chemotherapy regimensstandard neoadjuvant chemotherapy regimens for breast cancer: TAC, TE, etc. T: docetaxel, nab-paclitaxel or paclitaxel. Routine clinical dosage and administration shall be adopted. A: epirubicin, pirarubicin or doxorubicin. Routine clinical dosage and administration shall be adopted. C: cyclophosphamide 500 mg/m², IV. Q3W. Dose reduction and treatment delay are permitted; the maximum allowable delay is 3 weeks, calculated from the last administration date. Treatment shall be discontinued if this limit is exceeded. E: epirubicin. Routine clinical dosage and administration shall be adopted. | Drug | HR1, HR2, HR3, TNBC1, TNBC2, TNBC3 |
Primary outcome
Pathologic complete response（pCR）
Time frame: Up to12 months
pCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.
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 13 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab, SBRT and standard neoadjuvant chemotherapy regimens in people with Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
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 18 inclusion and 15 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: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Lina Zhang (86-22-23359337, linazhang2005@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response（pCR） (time frame: Up to12 months). 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 13 Feb 2026.