Recruiting

Neoadjuvant Radiation in Locally Advanced Breast Cancer

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…

ClinicalTrials.gov IDNCT05479409

PhasePHASE2

Enrollment70

SponsorFudan University

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Neoplasms

About this study

Interventions

Radiation: 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.
Dietary Supplement: β-alanine — β-alanine, 1.7g, tid, p.o
Radiation: 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.

Primary outcomes

Pathological response rate (1 year)
Fbjective response rate(ORR) (3 year)
Event free survival(EFS) (3 year)

Eligibility information

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.

Study locations

Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality 200032 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-03.