Combining SBRT with chemotherapy for breast cancer patients who don't respond to initial treatment

Efficacy and Safety Evaluation of Combined Preoperative Radiotherapy in Breast Cancer Patients With No Response to Initial Neoadjuvant Chemotherapy

This study is testing if adding a special type of radiation therapy to standard chemotherapy can help breast cancer patients who didn't respond to their initial treatment.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy, prednisone, radiation
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06596018 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of adding preoperative stereotactic body radiation therapy (SBRT) to standard chemotherapy in breast cancer patients who have not responded to initial neoadjuvant chemotherapy. Participants will be randomly assigned to either continue with standard chemotherapy or receive SBRT in addition to chemotherapy. The primary focus is on improving the pathological complete response (pCR) rates and assessing the safety and tolerability of this combined approach. The study will track outcomes such as pCR rates and breast conservation rates over time.

Who should consider this trial

Good fit: Ideal candidates include patients with stage II or III breast adenocarcinoma who have shown no response to two cycles of neoadjuvant chemotherapy.

Not a fit: Patients with early-stage breast cancer or those who have responded to initial chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for breast cancer patients who are currently not responding to standard chemotherapy.

How similar studies have performed: While the combination of SBRT with chemotherapy is a novel approach in this context, existing evidence suggests that preoperative radiation can be effective, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Hangzhou, Zhejiang

• The Department of Radiation Oncology，the Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Ting Zhang

Conditions Breast Adenocarcinoma; breast cancer; chemo-resistance; neoadjuvant radiation; pCR rate