Neoadjuvant radiation therapy for locally advanced breast cancer
Official title: Effect of Neoadjuvant Radiation and Prediction of Response to Treatment in Locally Advanced Breast Cancer
Run by Fudan University · NCT05479409 · Data updated 2026-11-12
This study is testing if adding radiation therapy to chemotherapy can help patients with locally advanced breast cancer who can't have surgery feel better and have more treatment options.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 70 (estimated) |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | March 1, 2021 |
| Main results expected | December 25, 2023 |
| Study ends | December 2027 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT05479409 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women with histologically confirmed locally advanced breast carcinoma who are inoperable after prior chemotherapy.
✕Probably not a fit
Patients with other concurrent malignancies, uncontrolled illnesses, or serious underlying medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of neoadjuvant radiation therapy combined with chemotherapy in patients with locally advanced breast cancer who are inoperable after receiving 4-6 courses of chemotherapy. The primary goal is to assess clinical outcomes, while a secondary goal is to identify biomarkers and imaging parameters that may predict treatment response. Patients will undergo ultrasound spectroscopy and provide fresh tumor tissue or blood samples for analysis before treatment. The study aims to improve local-regional control of the disease and enhance surgical options for patients.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and increase the chances of surgery for patients with inoperable locally advanced breast cancer.
How similar studies have gone: While the management of locally advanced breast cancer is complex, similar approaches using neoadjuvant therapies have shown promise in improving outcomes, though this specific combination is being explored in a novel context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or cytologically confirmed locally advanced breast carcinoma * Inoperable with with 4-6 courses of prior chemotherapy * No contradiction of radiation or chemo-radiotherapy * Patients should have the ability to understand and the willingness to sign a written informed consent document * Signed informed consent must be obtained prior to any study specific procedures Exclusion Criteria: * Other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or contralateral breast DCIS * Coagulation disorders * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia * Serious underlying medical illness with life expectancy less than 2 years. * Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
Where it's running
-
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Xiaoli Yu — Fudan University
- Study coordinator: Xiaoli Yu
- Email: xiaoliyu@fudan.edu.cn
- Phone: +86-021-64175590
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.