Breast CancerPhase 2NCT06914440
Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT), Toripalimab and Neoadjuvant Chemotherapy in people with Breast Cancer, run by Xijing Hospital at 2 sites in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant stereotactic body radiotherapy (SBRT) followed by nab-paclitaxel combined with toripalimab in patients with previously untreated HR+/HER2-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT), Toripalimab and Neoadjuvant Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesChina
- Study dates
- 5 Jun 2025to Dec 2030
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥18 and ≤75 years at the time of signing informed consent.
- ECOG PS status of 0-1.
- Histologically confirmed non-metastatic (M0) breast cancer, meeting all of the following:
- Clinical stage (per AJCC 8th edition) meeting one of the following: i. cT3N0, cT2-4N1-3, or cT1N2-3 (Stage IIB, IIIA, IIIB, or IIIC); ii. cT2N0 or cT1N1 (Stage IIA) with at least two of the following high-risk features: Histologic grade 3; Ki-67 ≥50%; Age <50 years and premenopausal status.
- Imaging assessments within 28 days prior to enrollment including: abdominal CT or ultrasound, bone scan (ECT), chest CT, and brain MRI.
- Histologically or pathologically confirmed invasive carcinoma, with all of the following:
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- Grade 2 or 3 (confirmed by central laboratory);
- ER-positive (>1% staining) and/or PR-positive (>1% staining) by IHC;
- HER2-negative (IHC 0/1+ or HER2/neu FISH ratio ≤1.8);
- Ki-67 ≥15%.
- Patient deemed eligible for radiotherapy after MDT evaluation.
- No prior antitumor therapy within 1 month before enrollment.
- Organ Function Requirements (within 7 days prior to enrollment):
- Complete blood count (no transfusion or hematopoietic growth factors within 7 days): ANC ≥1.5×10⁹/L; ALC ≥0.5×10⁹/L; Platelets ≥100×10⁹/L; Hemoglobin ≥90 g/L; WBC ≥3.0×10⁹/L and ≤15×10⁹/L;
- Blood biochemistry (no transfusion/albumin within 7 days): ALT/AST ≤2.5×ULN; ALP ≤2.5×ULN；BUN/Cr ≤1.5×ULN; Cr≥60 mL/min (Cockcroft-Gault formula);
- Coagulation: PT/APTT ≤1.5×ULN; INR ≤1.5×ULN (if no anticoagulant therapy);
- Urinalysis: Urine protein <2+; if ≥2+, 24-hour urine protein must be ≤1g;
- Thyroid function:TSH ≤1×ULN; if abnormal, normal T3/T4 levels required for eligibility.
- Women of childbearing potential must:
- Have a negative serum pregnancy test within 7 days before treatment;
- Use highly effective contraception during the study and for 180 days after the last dose.
- Voluntarily sign informed consent, demonstrate good compliance, and commit to follow-up.
Who cannot join
- Inflammatory Breast Cancer.
- Comorbidities/Medical History:
- Autoimmune disease: patients with any known or suspected autoimmune disease, except: hypothyroidism due to autoimmune thyroiditis managed with hormone replacement therapy only, stable type-1 diabetes with well-controlled blood glucose.
- Cardiovascular Diseases: poorly controlled hypertension despite medication (SBP >140 mmHg or DBP>90 mmHg). And with the history (within 6 months prior to enrollment) of myocardial infarction, severe/unstable angina, NYHA Class ≥2 heart failure, clinically significant arrhythmias as well as symptomatic congestive heart failure.
- Interstitial lung disease, non-infectious pneumonitis, or other uncontrolled systemic diseases (e.g., diabetes, pulmonary fibrosis, acute pneumonia);
- Vaccination: receipt of live attenuated vaccines within 28 days prior to enrollment or planned during the study;
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- Infections: HIV/AIDS, active hepatitis(HBV-DNA ≥500 IU/mL; HCV-RNA above detection limit), or co-infection with HBV and HCV, severe infections within 4 weeks prior to enrollment (e.g., bacteremia, severe pneumonia requiring hospitalization), active infection requiring systemic antibiotics (CTCAE≥Grade 2) within 2 weeks prior to treatment, active tuberculosis within 1 year prior to enrollment;
- Unexplained fever >38.5°C during screening (unless deemed tumor-related by the investigator);
- Malignancy History: other malignancies diagnosed within 5 years prior to enrollment (except adequately treated basal cell carcinoma, squamous cell skin cancer, or cervical carcinoma in situ);
- Surgery:Major surgery within 28 days prior to enrollment (diagnostic biopsies or PICC line placement are allowed);
- Transplant: Prior or planned allogeneic bone marrow or solid organ transplant;
- Neurological: peripheral neuropathy ≥Grade 2;
- Gastrointestinal: clinically significant bowel obstruction;
- Thrombotic Events: arterial/venous thrombosis within 6 months prior to enrollment (e.g., stroke, transient ischemic attack, DVT, pulmonary embolism);
- Bleeding Risk: hemoptysis (≥2.5 mL/day) within 2 months prior to enrollment, clinically significant bleeding within 3 months prior to enrollment (e.g. gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood≥++), and the known bleeding/thrombotic disorders (e.g., hemophilia, coagulopathy, thrombocytopenia, hypersplenism);
- Coagulation abnormalities (INR >1.5×ULN or APTT >1.5×ULN), or requiring long-term anticoagulation (warfarin/heparin) or antiplatelet therapy (aspirin≥300 mg/day or clopidogrel ≥75 mg/day).
- Treatment-Related Exclusions:
- Prior systemic targeted therapy or immunostimulants (e.g., interferon, IL-2) within 4 weeks before treatment;
- Known allergy to the investigational drug (recombinant humanized anti-PD-1 mAb) or its excipients.
- Clinical Trial Participation: participation in another drug trial within 4 weeks prior to enrollment, or within 5 half-lives of the last investigational drug dose.
- Substance Abuse: history of drug/alcohol abuse or dependency.
- Pregnancy/Lactation: pregnant, breastfeeding, or planning pregnancy during the study.
- Investigator' s Discretion: other conditions that may compromise subject safety or study integrity (e.g., severe lab abnormalities, social factors).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Xijing Hospital Affiliated to Air Force Military Medical University
Xi'an, Shannxi Province, 710032
Ting Wang, PhD, 0086-13700283101, ting_w100@126.com
- Recruiting
Xijing Hospital Affiliated to Air Force Military Medical University
Xi'an, Shannxi
Ting Wang, 0086-13700283101, ting_w100@126.com
About this study
Official title: Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer: A Single-arm, Prospective Clinical Trial
The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant stereotactic body radiotherapy (SBRT) followed by nab-paclitaxel combined with toripalimab in patients with previously untreated HR+/HER2-negative breast cancer. Eligible patients include those with stage IIB-IIIC disease (cT3N0, cT2-4N1-3 or cT1N2-3) or stage IIA disease (cT2N0 or cT1N1) with at least two of the following high-risk factors: histologic grade 3, Ki-67 ≥50% or premenopausal with age <50 years. A total of 27 enrolled patients will be assigned to receive the combination therapy. The primary question it aims to answer is whether this combination of radiotherapy, de-escalated chemotherapy, and immunotherapy can improve the total pathologic complete response (tpCR) rate (defined as ypT0/Tis ypN0).
Read the detailed description
HR-positive and HER2-negative (HR+/HER2-) breast cancer is the most common subtype of breast cancer. Although this subtype is generally associated with favorable overall survival, patients with high-risk features remain at substantial risk for late recurrence and distant metastasis. In particular, those presenting with large primary tumors (cT3 or higher) or axillary lymph node involvement face a significantly elevated risk of locoregional recurrence and distant metastasis relative to patients with earlier-stage, lower-risk disease.
In recent years, the role of neoadjuvant therapy in the comprehensive treatment of breast cancer has gained increasing attention. The pathological complete response (pCR) rate following neoadjuvant therapy is closely associated with long-term survival. However, compared to HER2+ or triple-negative breast cancer, HR+/HER2- breast cancer patients exhibit a significantly lower pCR rate with neoadjuvant chemotherapy alone. Neoadjuvant chemotherapy combined with immunotherapy has become a key treatment strategy for TNBC, this combination also improves pCR rates in HR+/HER2- breast cancer, though the benefit is less pronounced than in TNBC. Radiotherapy not only releases a large number of tumor antigens and inflammatory signals to enhance systemic anti-tumor immune responses, but also promotes the exposure of tumor cell surface antigens, thereby increasing the immunogenicity of the tumor microenvironment. The synergistic effect of radiotherapy and immunotherapy, when combined with chemotherapy, may further improve treatment efficacy. Based on these, we designed this clinical trial evaluating the effect of neoadjuvant radiotherapy combined with de-escalated chemotherapy and immunotherapy, aiming to explore its potential to improve pCR rates and long-term outcomes in HR+/HER2- breast cancer patients. Enrolled patients will receive four cycles of single-agent Nab-Paclitaxel plus Toripalimab within one week after stereotactic radiotherapy, followed by surgery and subsequent adjuvant therapy. Postoperative pCR rate and prognosis of participants will be analyzed in our clinical study.
- Conditions
- Breast Cancer
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), Toripalimab, Neoadjuvant Chemotherapy, Surgery, Adjuvant Chemotherapy
- Keywords
- Breast Cancer, Neoadjuvant therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
The prescribed dose of radiation is 24 Gy delivered in 3 fractions (8 Gy/fraction) using SBRT technique. Subjects received SBRT for the primary breast cancer lesion at 8Gy/Fraction each time for 3 consecutive days, 1 week before the start of systemic therapy. The first day of radiation is C1D1.
ToripalimabDrug
Toripalimab will be administered at a fixed dose of 240 mg via intravenous infusion every 3 weeks (q3w). The first dose is given on Cycle 2 Day 1 (C2D1), followed by dosing on the first day of each subsequent cycle for a total of 4 cycles. (Toripalimab×4 240mg D1 q3w)
Neoadjuvant ChemotherapyDrug
Combined with Toripalimab, Nab-paclitaxel will be dosed at 125 mg/m² based on body surface area, administered by intravenous infusion weekly (Days 1, 8, 15 of each 21-day cycle) for 4 cycles.(T×4, Nab-Paclitaxel 125mg/m2，D1、D8、D15 q3w).
SurgeryProcedure or surgery
Surgery will be performed 2-6 weeks after completion of neoadjuvant therapy. The surgical approach will be determined by the investigator based on disease status and patient preference.
Adjuvant ChemotherapyDrug
The anthracycline may be either Epirubicin (body surface area-adjusted 50 mg/m²) or Liposomal Doxorubicin (body surface area-adjusted 30 mg/m²) combined with Cyclophosphamide (body surface area-adjusted 600 mg/m²). Both drugs were administered intravenously every 3 weeks, and then the first day of each course was administered for 4 cycles. (EC×4, Epirubicin 50 mg/m² or Liposomal Doxorubicin 30 mg/m², comined with Cyclophosphamide 600 mg/m², D1, q3w)
Adjuvant RadiotherapyRadiation
Conventional radiotherapy will be delivered to the breast/chest wall and regional lymph nodes (investigator-selected technique), with explicit prohibition of tumor bed boost irradiation.
Endocrine therapyDrug
Investigator-selected adjuvant endocrine therapy will be deterimend according to applicable guidelines, considering menopausal status, recurrence risk, treatment history, comorbidities as well as patient preference.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | During the neoadjuvant treatment period, participants will undergo stereotactic radiotherapy and subsequently receive chemotherapy combined with immunotherapy. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Drug: Toripalimab; Drug: Neoadjuvant Chemotherapy; Procedure: Surgery; Drug: Adjuvant Chemotherapy; Radiation: Adjuvant Radiotherapy; Drug: Endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pathologic complete response (tpCR) rate according to RCB system
tpCR is defined as the absence of invasive carcinoma in the breast primary lesion and negative regional lymph nodes (ypT0/Tis ypN0) by hematoxylin-eosin staining after completion of the neoadjuvant treatment. RCB system will be used for the pathological evaluation after neoadjuvant therapy
Measured: At definitive surgery, following completion of neoadjuvant SBRT and 4 cycles of nab-paclitaxel plus toripalimab (each cycle is 21 days), approximately 4 months from start of neoadjuvant therapy.
Secondary outcomes (8)
RCB 0/I rate
The RCB 0/I rate is defined as the percentage of patients achieving either pathological complete response (RCB-0) or minimal residual disease (RCB-I), corresponding to near-pCR status
Measured: At definitive surgery, following completion of neoadjuvant SBRT and 4 cycles of nab-paclitaxel plus toripalimab (each cycle is 21 days), approximately 4 months from start of neoadjuvant therapy.
Breast pathologic complete response (bpCR) rate
bpCR is defined as the absence of residual invasive carcinoma in the breast primary lesion (ypT0/Tis; ductal carcinoma in situ may be present), regardless of regional lymph node status, assessed by hematoxylin and eosin (H\&E) staining after neoadjuvant therapy.
Measured: At definitive surgery, following completion of neoadjuvant SBRT and 4 cycles of nab-paclitaxel plus toripalimab (each cycle is 21 days), approximately 4 months from start of neoadjuvant therapy.
Axillary pathologic complete response (apCR) rate
apCR is defined as negative pathologic status of axillary lymph nodes (ypN0) after neoadjuvant therapy, assessed by H\&E staining.
Measured: At definitive surgery, following completion of neoadjuvant SBRT and 4 cycles of nab-paclitaxel plus toripalimab (each cycle is 21 days), approximately 4 months from start of neoadjuvant therapy.
Objective response rate (ORR)
ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) per RECIST version 1.1, as assessed by the investigator.
Measured: From start of neoadjuvant therapy until definitive surgery, assessed every 2 cycles (each cycle is 21 days) during neoadjuvant treatment.
EFS
Event-free survival (EFS) is defined as the time from the first neoadjuvant treatment to the first occurrence of any of the following events: (1) disease progression during neoadjuvant therapy (locoregional progression or distant metastasis) precluding radical surgery; (2) locoregional recurrence or distant metastasis after definitive surgery; (3) second primary malignancy; or (4) death from any cause.
Measured: From date of first neoadjuvant treatment until the date of first documented event, assessed up to 5 years.
iDFS
Invasive disease-free survival (iDFS) is defined as the time from the first neoadjuvant treatment to invasive disease recurrence (including local recurrence, ipsilateral and contralateral invasive breast cancer, distant recurrence), new primary tumor, or death from any cause.
Measured: From date of first neoadjuvant treatment until the date of first documented invasive disease recurrence or death, assessed up to 5 years.
OS
Overall survival (OS) is defined as the time from the first neoadjuvant treatment to death from any cause.
Measured: From date of first neoadjuvant treatment until the date of death from any cause, assessed up to 5 years.
Safety and tolerability
Incidence, severity, and type of treatment-related adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE version 5.0.
Measured: From signing of informed consent through 30 days after the last dose of study treatment, assessed up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start5 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2030 (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 Xijing 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914440
- Sponsor's protocol ID
- XJ-ViBranT-B-001
- Status last verified
- Jun 2026
- First submitted
- 30 Mar 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer: A Single-arm, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT06914440
- Acronym / sponsor ID
- XJ-ViBranT-B-001
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 6 Apr 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.
The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant stereotactic body radiotherapy (SBRT) followed by nab-paclitaxel combined with toripalimab in patients with previously untreated HR+/HER2-negative breast cancer. Eligible patients include those with stage IIB-IIIC disease (cT3N0, cT2-4N1-3 or cT1N2-3) or stage IIA disease (cT2N0 or cT1N1) with at least two of the following high-risk factors: histologic grade 3, Ki-67 ≥50% or premenopausal with age <50 years. A total of 27 enrolled patients will be assigned to receive the combination therapy. The primary question it aims to answer is whether this combination of radiotherapy, de-escalated chemotherapy, and immunotherapy can improve the total pathologic complete response (tpCR) rate (defined as ypT0/Tis ypN0).
Detailed description
HR-positive and HER2-negative (HR+/HER2-) breast cancer is the most common subtype of breast cancer. Although this subtype is generally associated with favorable overall survival, patients with high-risk features remain at substantial risk for late recurrence and distant metastasis. In particular, those presenting with large primary tumors (cT3 or higher) or axillary lymph node involvement face a significantly elevated risk of locoregional recurrence and distant metastasis relative to patients with earlier-stage, lower-risk disease.
In recent years, the role of neoadjuvant therapy in the comprehensive treatment of breast cancer has gained increasing attention. The pathological complete response (pCR) rate following neoadjuvant therapy is closely associated with long-term survival. However, compared to HER2+ or triple-negative breast cancer, HR+/HER2- breast cancer patients exhibit a significantly lower pCR rate with neoadjuvant chemotherapy alone. Neoadjuvant chemotherapy combined with immunotherapy has become a key treatment strategy for TNBC, this combination also improves pCR rates in HR+/HER2- breast cancer, though the benefit is less pronounced than in TNBC. Radiotherapy not only releases a large number of tumor antigens and inflammatory signals to enhance systemic anti-tumor immune responses, but also promotes the exposure of tumor cell surface antigens, thereby increasing the immunogenicity of the tumor microenvironment. The synergistic effect of radiotherapy and immunotherapy, when combined with chemotherapy, may further improve treatment efficacy. Based on these, we designed this clinical trial evaluating the effect of neoadjuvant radiotherapy combined with de-escalated chemotherapy and immunotherapy, aiming to explore its potential to improve pCR rates and long-term outcomes in HR+/HER2- breast cancer patients. Enrolled patients will receive four cycles of single-agent Nab-Paclitaxel plus Toripalimab within one week after stereotactic radiotherapy, followed by surgery and subsequent adjuvant therapy. Postoperative pCR rate and prognosis of participants will be analyzed in our clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT), Drug: Toripalimab, Drug: Neoadjuvant Chemotherapy, Procedure: Surgery, Drug: Adjuvant Chemotherapy, Radiation: Adjuvant Radiotherapy, Drug: Endocrine therapyDuring the neoadjuvant treatment period, participants will undergo stereotactic radiotherapy and subsequently receive chemotherapy combined with immunotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Female patients aged ≥18 and ≤75 years at the time of signing informed consent.
- ECOG PS status of 0-1.
- Histologically confirmed non-metastatic (M0) breast cancer, meeting all of the following:
- Histologically or pathologically confirmed invasive carcinoma, with all of the following:
- Patient deemed eligible for radiotherapy after MDT evaluation.
Key exclusion criteria (23 listed)
- Inflammatory Breast Cancer.
- Comorbidities/Medical History:
- Treatment-Related Exclusions:
- Clinical Trial Participation: participation in another drug trial within 4 weeks prior to enrollment, or within 5 half-lives of the last investigational drug dose.
- Substance Abuse: history of drug/alcohol abuse or dependency.
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 |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)The prescribed dose of radiation is 24 Gy delivered in 3 fractions (8 Gy/fraction) using SBRT technique. Subjects received SBRT for the primary breast cancer lesion at 8Gy/Fraction each time for 3 consecutive days, 1 week before the start of systemic therapy. The first day of radiation is C1D1. | Radiation | Treatment |
| ToripalimabToripalimab will be administered at a fixed dose of 240 mg via intravenous infusion every 3 weeks (q3w). The first dose is given on Cycle 2 Day 1 (C2D1), followed by dosing on the first day of each subsequent cycle for a total of 4 cycles. (Toripalimab×4 240mg D1 q3w) | Drug | Treatment |
| Neoadjuvant ChemotherapyCombined with Toripalimab, Nab-paclitaxel will be dosed at 125 mg/m² based on body surface area, administered by intravenous infusion weekly (Days 1, 8, 15 of each 21-day cycle) for 4 cycles.(T×4, Nab-Paclitaxel 125mg/m2，D1、D8、D15 q3w). | Drug | Treatment |
| SurgerySurgery will be performed 2-6 weeks after completion of neoadjuvant therapy. The surgical approach will be determined by the investigator based on disease status and patient preference. | Procedure or surgery | Treatment |
| Adjuvant ChemotherapyThe anthracycline may be either Epirubicin (body surface area-adjusted 50 mg/m²) or Liposomal Doxorubicin (body surface area-adjusted 30 mg/m²) combined with Cyclophosphamide (body surface area-adjusted 600 mg/m²). Both drugs were administered intravenously every 3 weeks, and then the first day of each course was administered for 4 cycles. (EC×4, Epirubicin 50 mg/m² or Liposomal Doxorubicin 30 mg/m², comined with Cyclophosphamide 600 mg/m², D1, q3w) | Drug | Treatment |
| Adjuvant RadiotherapyConventional radiotherapy will be delivered to the breast/chest wall and regional lymph nodes (investigator-selected technique), with explicit prohibition of tumor bed boost irradiation. | Radiation | Treatment |
| Endocrine therapyInvestigator-selected adjuvant endocrine therapy will be deterimend according to applicable guidelines, considering menopausal status, recurrence risk, treatment history, comorbidities as well as patient preference. | Drug | Treatment |
Primary outcome
Total pathologic complete response (tpCR) rate according to RCB system
Time frame: At definitive surgery, following completion of neoadjuvant SBRT and 4 cycles of nab-paclitaxel plus toripalimab (each cycle is 21 days), approximately 4 months from start of neoadjuvant therapy.
tpCR is defined as the absence of invasive carcinoma in the breast primary lesion and negative regional lymph nodes (ypT0/Tis ypN0) by hematoxylin-eosin staining after completion of the neoadjuvant treatment. RCB system will be used for the pathological evaluation after neoadjuvant therapy
8 secondary outcomes
RCB 0/I rate
Time frame: At definitive surgery, following completion of neoadjuvant SBRT and 4 cycles of nab-paclitaxel plus toripalimab (each cycle is 21 days), approximately 4 months from start of neoadjuvant therapy.
Breast pathologic complete response (bpCR) rate
Time frame: At definitive surgery, following completion of neoadjuvant SBRT and 4 cycles of nab-paclitaxel plus toripalimab (each cycle is 21 days), approximately 4 months from start of neoadjuvant therapy.
Axillary pathologic complete response (apCR) rate
Time frame: At definitive surgery, following completion of neoadjuvant SBRT and 4 cycles of nab-paclitaxel plus toripalimab (each cycle is 21 days), approximately 4 months from start of neoadjuvant therapy.
Objective response rate (ORR)
Time frame: From start of neoadjuvant therapy until definitive surgery, assessed every 2 cycles (each cycle is 21 days) during neoadjuvant treatment.
EFS
Time frame: From date of first neoadjuvant treatment until the date of first documented event, assessed up to 5 years.
iDFS
Time frame: From date of first neoadjuvant treatment until the date of first documented invasive disease recurrence or death, assessed up to 5 years.
OS
Time frame: From date of first neoadjuvant treatment until the date of death from any cause, assessed up to 5 years.
Safety and tolerability
Time frame: From signing of informed consent through 30 days after the last dose of study treatment, assessed up to 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 14 Aug 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT), Toripalimab and Neoadjuvant Chemotherapy in people with Breast Cancer, run by Xijing Hospital at 2 sites 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 22 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 JIAJUN DING (15121089323, yuki_ding1996@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total pathologic complete response (tpCR) rate according to RCB system (time frame: At definitive surgery, following completion of neoadjuvant SBRT and 4 cycles of nab-paclitaxel plus toripalimab (each cycle is 21 days), approximately 4 months from start of neoadjuvant therapy.). 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 14 Aug 2026.