Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorXijing Hospital
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.
Eligibility criteria
Qualifiers
Female patients aged ≥18 and ≤75 years at the time of signing informed consent.
ECOG PS status of 0-1.
Clinical stage: Stage IIB, IIIA, IIIB, or IIIC
Required imaging assessments (within 28 days): Abdominal CT, ECT Bone scan, Chest CT and Brain MRI
Disqualifiers
Inflammatory Breast Cancer.
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);
Trial design
Treatments tested in this trial
- Stereotactic Body Radiation Therapy (SBRT)
- Toripalimab
- Neoadjuvant Chemotherapy
- Surgery
- Adjuvant Chemotherapy
- Adjuvant Radiotherapy
- Endocrine therapy
Treatment groups
27 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov