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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 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052636
Enrollment
Unknown
Registered
2021-11-02
Start date
2021-11-15
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Control group:stereotactic body radiation therapy
Experimental group:Combination of SBRT and SHR6390 plus endocrine therapy

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed invasive breast cancer; 2. ER, PR and HER2 detection meet the following conditions to enter the corresponding queue: (1) TNBC cohort: ER, PR, HER2-negative breast cancer patients; (2) HR+/HER2-BC cohort: patients with ER-positive and HER2-negative breast cancer. 3. The primary lesion is larger than 2cm; 4. ECOG score 0-1; 5. Laboratory and equipment inspection, meet the following requirements: (1) Neutrophil count >= 1 500/mm3 (1.5 x 10^9/L); (2) Platelet count >= 100 000/mm3 (100 x 10^9/L); (3) Hemoglobin: TNBC cohort >= 10.0 g/dL (100 g/L), HR+/HER2- cohort >= 9.0 g/dL (90 g/L); (4) Serum creatinine = 50%.

Exclusion criteria

Exclusion criteria: 1. Received any form of anti-tumor therapy in the past (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.); 2. Inflammatory breast cancer; 3. There are contraindications to breast cancer radiotherapy; 4. Distant metastasis.

Design outcomes

Primary

MeasureTime frame
TNBC cohort pCR proportion after neoadjuvant therapy;Residual cancer burden (RCB) 0-1 for HR+/HER2-BC;Serious adverse events (SAE);—

Secondary

MeasureTime frame
HR+/HER2-BC cohort pCR ratio after neoadjuvant therapy;Residual cancer burden (RCB) 0-1 for TNBC;Objective response rate(ORR);Adverse events (AE);—

Countries

China

Contacts

Public ContactLiu Caigang

Shengjing Hospital of China Medical University

liucg@sj-hospital.org+86 18940254967

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026