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

Breast Cancer Clinical Trial

Official title:

Study 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05132790
• Other study ID #: BC-NEO-IIT-SHR1316-SHR6390-RT
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: January 2024
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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

Radiation:
• SBRT
radiation therapy for breast cance before surgery.

Locations

Country	Name	City	State
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning

Sponsors (2)

Lead Sponsor	Collaborator
Shengjing Hospital	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Objective response rate(ORR)	ORR by investigator using RECIST Guideline (Version 1.1)	Up to11 months
Other	Adverse reactions(AE) and Serious adverse reactions (SAE)	Adverse reactions(AE) and Serious adverse reactions during the study	Through study completion, an average of 15 months
Primary	Pathological complete response (pCR) for TNBC group	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.	Up to11 months
Primary	Residual cancer burden (RCB) 0-I index for HER2-/HR+BC group	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	Up to11 months
Secondary	Pathological complete response (pCR) forHER2-/HR+BC group	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.	Up to11 months
Secondary	Residual cancer burden (RCB) 0-I index for TNBC group	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	Up to11 months