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 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).
Eligibility criteria
Qualifiers
Female patients aged ≥18 and ≤75 years at the time of signing informed consent.
ECOG PS status of 0-1.
Grade 2 or 3 (confirmed by central laboratory);
ER-positive (>1% staining) and/or PR-positive (>1% staining) by IHC;
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