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

NCT05132790 | Active Not Recruiting DMC

• 1 other identifier: BC-NEO-IIT-SHR1316-SHR6390-RT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Pathological complete response (pCR) forHER2-/HR+BC group

  Up to11 months

• Residual cancer burden (RCB) 0-I index for TNBC group

  Up to11 months

Other Outcomes (2)

• Objective response rate(ORR)

  Up to11 months

• Adverse reactions（AE） and Serious adverse reactions （SAE)

  Through study completion, an average of 15 months

Study Arms (2)

TNBC

EXPERIMENTAL

Drug: SHR-1316 at a dose 20mg/kg q3w; Radiation: SBRT

HER2-/HR+BC

EXPERIMENTAL

Drug: SHR6390 at a dose of 150mg orally, daily; Radiation: SBRT

Interventions

SHR-1316 at a dose 20mg/kg q3w DRUG

Combination of SBRT and SHR1316, followed by SHR1316 plus nab-paclitaxel and carboplatin or cisplatin

TNBC

SHR6390 at a dose of 150mg orally, daily DRUG

SHR6390 plus exemestane with/without ovarian function suppression/ablation (OFS) after SBRT

HER2-/HR+BC

SBRT RADIATION

radiation therapy for breast cance before surgery.

HER2-/HR+BC; TNBC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shengjing Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

Related Publications (2)

• Zhang Y, Cao S, Niu N, Shan H, Xue J, Chen G, Xu Y, Yin J, Liu C, Sun L, Jiang X, Tang M, Xu Q, Jia M, Zhang X, Zhang Z, Zhang Q, Wang J, Li A, Yang Y, Liu C. Efficacy and safety of neoadjuvant stereotactic body radiation therapy plus dalpiciclib and exemestane for hormone receptor-positive, HER2-negative breast cancer: A prospective pilot study. Elife. 2025 Jul 28;14:RP101583. doi: 10.7554/eLife.101583.

  PMID: 40719174 DERIVED

• Chen G, Gu X, Xue J, Zhang X, Yu X, Zhang Y, Li A, Zhao Y, He G, Tang M, Xing F, Yin J, Bian X, Han Y, Cao S, Liu C, Jiang X, Zhang K, Xia Y, Li H, Niu N, Liu C; Northeastern Clinical Research Alliance of Oncology (NCRAO). Effects of neoadjuvant stereotactic body radiotherapy plus adebrelimab and chemotherapy for triple-negative breast cancer: A pilot study. Elife. 2023 Dec 22;12:e91737. doi: 10.7554/eLife.91737.

  PMID: 38131294 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 24, 2021
• Study Start: September 25, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)