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Active, Not Recruiting

NCT Number: NCT05132790

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR-1316 at a dose 20mg/kg q3w

Drug

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

SHR6390 at a dose of 150mg orally, daily

Drug

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

SBRT

Radiation

radiation therapy for breast cance before surgery.

Primary outcomes

  1. Pathological complete response (pCR) for TNBC group

    Time frame: 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.

  2. Residual cancer burden (RCB) 0-I index for HER2-/HR+BC group

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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

Other outcomes

  1. Objective response rate(ORR)

    Time frame: Up to11 months

    ORR by investigator using RECIST Guideline (Version 1.1)

  2. Adverse reactions(AE) and Serious adverse reactions (SAE)

    Time frame: Through study completion, an average of 15 months

    Adverse reactions(AE) and Serious adverse reactions during the study

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2028
First posted
Nov 24, 2021
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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