Neoadjuvant Radiation in Locally Advanced Breast Cancer

NCT05479409 · tracked via the Priya Life Science China tracker

Sponsor

Fudan University

Phase

Phase 2

Started

2021-03-01

Last updated

2026-06-26

Condition(s) studied

Breast Neoplasms

Investigational drug(s) / intervention(s)

Neoadjuvant radiotherapyβ-alanineSpatially fractionated radiotherapy

Neoadjuvant radiotherapy: The preoperative radiation dose will be 50 Gy in 25 fractions to the breast and regional lymph node PTV, followed by surgical evaluation. Operable patients will proceed to surgery; inoperable patients will continue radiotherapy to 60 Gy in 30 fractions, with residual breast and nodal lesions boosted to 66 Gy in 33 fractions.

β-alanine: β-alanine, 1.7g, tid, p.o

Spatially fractionated radiotherapy: Spatially fractionated radiotherapy will be delivered as a lattice radiotherapy boost. The high-dose gross tumor volume (GTV) will receive 15 Gy in 1 fraction. The conventional clinical target volume (CTV), including the ipsilateral breast and regional lymphatic drainage area, will receive 40.05 Gy in 15 fractions. The boost volume, if applicable, including positive lymphatic drainage areas, will receive an additional 10 Gy in 5 fractions.

Study summary

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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

70 Years

Healthy volunteers

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.

Primary outcome measure(s)

Pathological response rate — 1 year
only for operable patients
Fbjective response rate(ORR) — 3 year
for inoperable patients
Event free survival(EFS) — 3 year
for all patients

Trial sites (1)

Facility	City	Region	Status
Fudan University Shanghai Cancer Center	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05479409 on ClinicalTrials.gov ↗ ← All trials in China