Assessing Combined SBRT in Breast Cancer Non-Responders to Neoadjuvant Chemotherapy

NCT06596018 | Recruiting Phase 1 DMC

• 1 other identifier: Y2024-0756
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess whether the addition of preoperative stereotactic body radiation therapy (SBRT) can improve pathological complete response (pCR) rates and safety in breast cancer patients who do not respond to initial neoadjuvant chemotherapy. The main questions it aims to answer are:

• Can the combination of SBRT with chemotherapy increase pCR rates in non-responders to initial neoadjuvant chemotherapy?
• Does the addition of SBRT to chemotherapy have acceptable safety and tolerability profiles? Participants in this trial will be early or locally advanced breast cancer patients who have shown no response to two cycles of standard neoadjuvant chemotherapy. They will be randomly assigned to either continue with the standard chemotherapy (control group) or receive SBRT in addition to continuing the standard chemotherapy (intervention group). The primary outcome measures will be pCR rate and breast conservation rate. Secondary outcomes will include 3-year local progression-free survival, overall survival, surgical complications, and treatment toxicities.

Conditions

Breast Adenocarcinoma

Keywords

breast cancer; chemo-resistance; neoadjuvant radiation; pCR rate

Outcome Measures

Primary Outcomes (2)

• Breast conservation rate

  Breast conservation rate

  Intraoperative

• pCR rate

  Pathological complete response (pCR), defined by the absence of invasive residual primary tumor in the breast and lymph node.The primary objective of this study is to compare pCR rates after continuing chemotherapy plus SBRT versus continuing chemotherapy alone in patients with non-response to initial 2 cycles of neoadjuvant chemotherapy.

  At the end of chemotherapy up to 21 weeks

Secondary Outcomes (2)

• 3-year PFS

  3 years after completion of treatment

• Acute and late toxicities

  At the end of chemotherapy and after surgery and after radiotherapy At the end of chemotherapy and after surgery and after radiotherapy: up to 30 weeks

Study Arms (2)

The control group

ACTIVE COMPARATOR

Patients in this group will continue to follow the original chemotherapy using anthracycline and/or taxane based regimens, according to their physician's preference and center policy

Drug: Chemotherapy

The SBRT-combined group

EXPERIMENTAL

The intervention group will receive SBRT treatment. The specific plan for SBRT is to target the primary tumor region with 24Gy/3. After the completion of SBRT, patients will continue the remaining courses of neoadjuvant chemotherapy.

Radiation: SBRT; Drug: Chemotherapy

Interventions

SBRT RADIATION

Target the primary tumor region with a single dose of 8Gy using 6MV-X rays, administered once a day for three consecutive days.

The SBRT-combined group

Chemotherapy DRUG

Continue to follow the original chemotherapy regimen（anthracycline and/or taxane based regimens）

The SBRT-combined group; The control group

Eligibility Criteria

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

You may qualify if:

• Confirmed histologic diagnosis of invasive adenocarcinoma of the breast;
• Stage T1-4N+M0 breast cancer (i.e., stages II and III);
• Breast MRI showing no extracapsular extension of lymph node involvement;
• The standard neoadjuvant chemotherapy regimen has been deemed ineffective after two cycles, with disease assessed as stable (SD) or progressive (PD) according to RECIST 1.1 criteria;
• ECOG performance status score of 0-2;
• Screening laboratory values must meet the following criteria:
• i. White blood cells (WBCs) ≥ 2000/μL ii. Absolute neutrophil count (ANC) ≥ 1500/μL iii. Platelets ≥ 100 x 103/μL iv. Hemoglobin ≥ 11.0 g/dL v. Serum creatinine ≤ 2 mg/dL (or glomerular filtration rate ≥ 40 ml/min) vi. AST ≤ 2.5 x upper limit of normal (ULN) vii. ALT ≤ 2.5 x ULN viii. Total bilirubin within normal limits (except subjects with Gilbert\'s syndrome, who must have total bilirubin \< 3.0 mg/dL) ix. INR ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulant(s) x. Negative HIV screening test xi. Negative screening tests for Hepatitis B and Hepatitis C. Patients with positive results that do not indicate true active or chronic infection may enroll after discussion and consensus agreement by the treating physician and principal investigator.

You may not qualify if:

• Evidence of metastatic disease;
• Known additional malignancy that is progressing or has required active treatment within the past 3 years；
• Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug；
• Patients with other concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study；
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Department of Radiation Oncology，the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Ting Zhang

CONTACT

+86-571-87783521; zezht@zju.edu.cn

Yucui Zhao

CONTACT

+86 18818270910; yucui_zhao@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: December 25, 2024
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): September 20, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-09

Locations

CN (1)