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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer

Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer: A Single-arm, Prospective Clinical Trial

Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer (NCT06914440) is a Phase 2 interventional studying Breast Cancer, sponsored by Xijing Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant radiotherapy followed by chemotherapy combined with immunotherapy in patients with previously untreated stage IIB-IIIC (cT3N0 or cT2-4N1-3) HR-positive and HER2-negative breast cancer. 27 enrolled patients will be assigned to receive stereotactic body radiotherapy followed by Nab-Paclitaxel combined with Toripalimab. The main question it aims th answer is that whether the combination therapy of radiotherapy, de-escalated chemotherapy, and immunotherapy could improve the pCR rate of HR-positive and HER2-negative breast cancer.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Breast Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 27 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Female patients aged ≥18 and ≤75 years at the time of signing willing to sign a consent form. 2. ECOG PS status of 0-1. 3. Breast cancer assessed as non-metastatic (M0), meeting all of the following: 1. Clinical stage: Stage IIB, IIIA, IIIB, or IIIC 2. Required imaging assessments (within 28 days): Abdominal CT, ECT Bone scan, Chest CT and Brain MRI 4. Histologically or pathologically confirmed invasive carcinoma of no special type, with all of the following: 1. Grade 2 or 3 (confirmed by central laboratory); 2. ER-positive (\>1% staining) and/or PR-positive (\>1% staining) by IHC; 3. HER2-negative (IHC 0/1+ or HER2/neu FISH ratio ≤1.8); 4. Ki-67 ≥15%. 5. Patient deemed eligible for radiotherapy after MDT evaluation. 6. No prior antitumor therapy within 1 month before enrollment. 7. Organ Function Requirements (within 7 days prior to enrollment): 1. Complete blood count (no transfusion or hematopoietic growth factors within 7 days): white blood cell count (ANC) at least 1.5×10⁹/L; ALC ≥0.5×10⁹/L; platelet count at least 100×10⁹/L; blood count (hemoglobin) at least 90 g/L; WBC ≥3.0×10⁹/L and ≤15×10⁹/L; 2. 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); 3. Coagulation: PT/APTT ≤1.5×ULN; INR ≤1.5×ULN (if no anticoagulant therapy); 4. Urinalysis: Urine protein \<2+; if ≥2+, 24-hour urine protein must be ≤1g; 5. Thyroid function:TSH ≤1×ULN; if abnormal, normal T3/T4 levels required for eligibility. 8. Women of childbearing potential must: 1. Have a negative serum pregnancy test within 7 days before treatment; 2. Use highly effective contraception during the study and for 180 days after the last dose. 9. Voluntarily sign willing to sign a consent form, demonstrate good compliance, and commit to follow-up. Who Should NOT Join This Trial: 1. Inflammatory Breast Cancer. 2. Comorbidities/Medical History: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Female patients aged ≥18 and ≤75 years at the time of signing informed consent. 2. ECOG PS status of 0-1. 3. Breast cancer assessed as non-metastatic (M0), meeting all of the following: 1. Clinical stage: Stage IIB, IIIA, IIIB, or IIIC 2. Required imaging assessments (within 28 days): Abdominal CT, ECT Bone scan, Chest CT and Brain MRI 4. Histologically or pathologically confirmed invasive carcinoma of no special type, with all of the following: 1. Grade 2 or 3 (confirmed by central laboratory); 2. ER-positive (\>1% staining) and/or PR-positive (\>1% staining) by IHC; 3. HER2-negative (IHC 0/1+ or HER2/neu FISH ratio ≤1.8); 4. Ki-67 ≥15%. 5. Patient deemed eligible for radiotherapy after MDT evaluation. 6. No prior antitumor therapy within 1 month before enrollment. 7. Organ Function Requirements (within 7 days prior to enrollment): 1. 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; 2. 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); 3. Coagulation: PT/APTT ≤1.5×ULN; INR ≤1.5×ULN (if no anticoagulant therapy); 4. Urinalysis: Urine protein \<2+; if ≥2+, 24-hour urine protein must be ≤1g; 5. Thyroid function:TSH ≤1×ULN; if abnormal, normal T3/T4 levels required for eligibility. 8. Women of childbearing potential must: 1. Have a negative serum pregnancy test within 7 days before treatment; 2. Use highly effective contraception during the study and for 180 days after the last dose. 9. Voluntarily sign informed consent, demonstrate good compliance, and commit to follow-up. Exclusion Criteria: 1. Inflammatory Breast Cancer. 2. Comorbidities/Medical History: 1. 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. 2. 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. 3. Interstitial lung disease, non-infectious pneumonitis, or other uncontrolled systemic diseases (e.g., diabetes, pulmonary fibrosis, acute pneumonia); 4. Vaccination: receipt of live attenuated vaccines within 28 days prior to enrollment or planned during the study; 5. 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; 6. Unexplained fever \>38.5°C during screening (unless deemed tumor-related by the investigator); 7. 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); 8. Surgery:Major surgery within 28 days prior to enrollment (diagnostic biopsies or PICC line placement are allowed); 9. Transplant: Prior or planned allogeneic bone marrow or solid organ transplant; 10. Neurological: peripheral neuropathy ≥Grade 2; 11. Gastrointestinal: clinically significant bowel obstruction; 12. Thrombotic Events: arterial/venous thrombosis within 6 months prior to enrollment (e.g., stroke, transient ischemic attack, DVT, pulmonary embolism); 13. 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); 14. 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). 3. Treatment-Related Exclusions: 1. Prior systemic targeted therapy or immunostimulants (e.g., interferon, IL-2) within 4 weeks before treatment; 2. Known allergy to the investigational drug (recombinant humanized anti-PD-1 mAb) or its excipients. 4. 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. 5. Substance Abuse: history of drug/alcohol abuse or dependency. 6. Pregnancy/Lactation: pregnant, breastfeeding, or planning pregnancy during the study. 7. Investigator' s Discretion: other conditions that may compromise subject safety or study integrity (e.g., severe lab abnormalities, social factors).

Treatments Being Tested

RADIATION

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.

DRUG

Toripalimab

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)

DRUG

Neoadjuvant Chemotherapy

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).

PROCEDURE

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.

DRUG

Adjuvant Chemotherapy

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)

RADIATION

Adjuvant Radiotherapy

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.

DRUG

Endocrine therapy

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.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Xijing Hospital Affiliated to Air Force Military Medical University
Xi'an, Shannxi Province, China
Xijing Hospital Affiliated to Air Force Military Medical University
Xi'an, Shannxi, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06914440), the sponsor (Xijing Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06914440 clinical trial studying?

The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant radiotherapy followed by chemotherapy combined with immunotherapy in patients with previously untreated stage IIB-IIIC (cT3N0 or cT2-4N1-3) HR-positive and HER2-negative breast cancer. 27 enrolled patients will be assigned to receive stereotactic body radiotherapy followed by Nab-Paclitaxel combined with Toripalimab. The main question it aims th answer is that whether the combination therapy of radiotherapy, de-escalated chemotherapy, and immunotherapy could improve the pCR rate of HR-positive and HER2-negati… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06914440?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06914440?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06914440. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06914440. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.