Breast Cancer Study of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Drug: SHR-1316 at a dose 20mg/kg q3w; Drug: SHR6390 at a dose of 150mg orally, daily; Radiation: SBRT

• Registration Number: NCT05132790
• Lead Sponsor: Shengjing Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-24
• Study Start: 2023-09-25
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-03
• Primary Completion: 2024-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TNBC	SHR-1316 at a dose 20mg/kg q3w	-
TNBC	SBRT	-
HER2-/HR+BC	SHR6390 at a dose of 150mg orally, daily	-
HER2-/HR+BC	SBRT	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Residual cancer burden (RCB) 0-I index for TNBC 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
Pathological complete response (pCR) forHER2-/HR+BC 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.

Trial Locations

Locations (1)

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China