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

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SHR-1316 at a dose 20mg/kg q3w
SHR6390 at a dose of 150mg orally, daily
SBRT
Sponsored by
Shengjing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Shengjing Hospital of China Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TNBC

HER2-/HR+BC

Arm Description

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
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

Full Information

First Posted
November 1, 2021
Last Updated
April 17, 2023
Sponsor
Shengjing Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05132790
Brief Title
Breast Cancer Study of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 12, 2021 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TNBC
Arm Type
Experimental
Arm Title
HER2-/HR+BC
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SHR-1316 at a dose 20mg/kg q3w
Intervention Description
Combination of SBRT and SHR1316, followed by SHR1316 plus nab-paclitaxel and carboplatin or cisplatin
Intervention Type
Drug
Intervention Name(s)
SHR6390 at a dose of 150mg orally, daily
Intervention Description
SHR6390 plus exemestane with/without ovarian function suppression/ablation (OFS) after SBRT
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
radiation therapy for breast cance before surgery.
Primary Outcome Measure Information:
Title
Pathological complete response (pCR) for TNBC group
Description
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.
Time Frame
Up to11 months
Title
Residual cancer burden (RCB) 0-I index for HER2-/HR+BC group
Description
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
Time Frame
Up to11 months
Secondary Outcome Measure Information:
Title
Pathological complete response (pCR) forHER2-/HR+BC group
Description
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.
Time Frame
Up to11 months
Title
Residual cancer burden (RCB) 0-I index for TNBC group
Description
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
Time Frame
Up to11 months
Other Pre-specified Outcome Measures:
Title
Objective response rate(ORR)
Description
ORR by investigator using RECIST Guideline (Version 1.1)
Time Frame
Up to11 months
Title
Adverse reactions（AE） and Serious adverse reactions （SAE)
Description
Adverse reactions（AE） and Serious adverse reactions during the study
Time Frame
Through study completion, an average of 15 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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