SHR-1316 at a dose 20mg/kg q3wSHR6390 at a dose of 150mg orally, dailySBRT
SHR-1316 at a dose 20mg/kg q3w: Combination of SBRT and SHR1316, followed by SHR1316 plus nab-paclitaxel and carboplatin or cisplatin
SHR6390 at a dose of 150mg orally, daily: SHR6390 plus exemestane with/without ovarian function suppression/ablation (OFS) after SBRT
SBRT: radiation therapy for breast cance before surgery.
Study summary
The study is being conducted to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) combined neoadjuvant treatment for patients with triple-negative and hormone receptor-positive, HER2-negative breast cancer
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Confirmed histologic diagnosis of invasive adenocarcinoma of the breast
* ER, PR and HER2 testing, and
* TNBC patients （ HER2-neu 0-1+ by IHC or FISH-negative by ASCO CAP guidelines）
* ER-positive and HER2-negative breast cancer
* tumor measuring ≥2 cm in maximal diameter as measured by any available standard of care imaging (mammogram, breast ultrasound, breast MRI)
* Any nodal status
* ECOG Performance Status of 0 -1
* Screening laboratory values must meet the following criteria:
i. Absolute neutrophil count (ANC) ≥1.5 × 109/L ii. Platelets ≥100 × 109/L iii. Hemoglobin ≥ 10.0 g/dl for TNBC, ≥ 10.0 g/dl for HR+/HER2-BC iv. Serum creatinine ≤1.5 x upper limit of normal (ULN) v. AST ≤ 2.5 xULN vi. ALT ≤ 2.5 x ULN vii. Total bilirubin ≤ 2.5 xULN viii left ventricular ejection fraction ≥ 50%.
Exclusion Criteria:
* Any kind of prior treatment for breast cancer, including chemotherapy, radiotherapy, endocrine therapy and so on
* Inflammatory breast cancer
* Pregnant and lactating women;
* distant metastasis
* patients who have participated in other clinical trials.
Primary outcome measure(s)
Pathological complete response (pCR) for TNBC group — Up to11 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.
Residual cancer burden (RCB) 0-I index for HER2-/HR+BC group — Up to11 months Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 5 variables are included in a calculation formula to evaluate the total index(0-III), the higher scores mean a worse outcome
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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