NCT05479409RecruitingPhase 2
Neoadjuvant Radiation in Locally Advanced Breast Cancer
Effect of Neoadjuvant Radiation and Prediction of Response to Treatment in Locally Advanced Breast Cancer
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy and safety of neoadjuvant radiation therapy in improving local-regional control and facilitating surgical conversion in patients with inoperable locally advanced breast cancer after 2-6 courses of neoadjuvant chemotherapy. This study will also investigate whether beta-alanine supplementation and spatially fractionated radiotherapy can enhance the therapeutic response to neoadjuvant chemoradiotherapy. In addition, this study aims to explore tumor microenvironmental features and molecular biomarkers associated with treatment response, radioresistance, immune activation, and long-term outcomes.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 29 Jun 2022
- Start date
- Mar 2021
- Primary completion date
- Dec 2023
- Lead sponsor
- Fudan University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05479409
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From Mar 2021 to the primary completion date, Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or contralateral breast DCIS
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.