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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: SHR-1316 at a dose 20mg/kg q3w; Radiation: SBRT; Drug: SHR6390 at a dose of 150mg orally, daily

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital Of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TNBC	Drug: SHR-1316 at a dose 20mg/kg q3w; Combination of SBRT and SHR1316, followed by SHR1316 plus nab-paclitaxel and carboplatin or cisplatin; Radiation: SBRT; radiation therapy for breast cance before surgery.
Experimental: HER2-/HR+BC	Radiation: SBRT; radiation therapy for breast cance before surgery.; Drug: SHR6390 at a dose of 150mg orally, daily; SHR6390 plus exemestane with/without ovarian function suppression/ablation (OFS) after SBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate(ORR)	ORR by investigator using RECIST Guideline (Version 1.1)	Up to11 months
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

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: BC-NEO-IIT-SHR1316-SHR6390-RT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Findings from this study will indicate whether stereotactic body radiation therapy (SBRT) combined neoadjuvant treatment for patients with triple-negative and hormone receptor-positive, HER2-negative breast cancer is safe and effective.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No