Neoadjuvant Radiation in Locally Advanced Breast Cancer

NCT05479409 | Recruiting Phase 2

• 1 other identifier: FDRT-BC016
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Neoplasms

Keywords

breast cancer; neoadjuvant radiotherapy; biomarkers

Outcome Measures

Primary Outcomes (3)

• Pathological response rate

  only for operable patients

  1 year

• Fbjective response rate(ORR)

  for inoperable patients

  3 year

• Event free survival(EFS)

  for all patients

  3 year

Secondary Outcomes (2)

• Time to progression

  3 year

• Radiation Toxicity

  6 months

Other Outcomes (2)

• Biologic predictor for treatment response

  before treatment

• The role of ultrasound in predicting treatment response

  before and 1 month after treatment

Study Arms (3)

Neoadjuvant radiotherapy

EXPERIMENTAL

Radiation: Neoadjuvant radiotherapy

β-alanine plus neoadjuvant radiotherapy

EXPERIMENTAL

Radiation: Neoadjuvant radiotherapy; Dietary Supplement: β-alanine

Spatially fractionated radiotherapy

EXPERIMENTAL

Radiation: Spatially fractionated radiotherapy

Interventions

Neoadjuvant radiotherapy RADIATION

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.

Neoadjuvant radiotherapy; β-alanine plus neoadjuvant radiotherapy

β-alanine DIETARY_SUPPLEMENT

β-alanine, 1.7g, tid, p.o

β-alanine plus neoadjuvant radiotherapy

Spatially fractionated radiotherapy RADIATION

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.

Spatially fractionated radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Xiaoli Yu

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoli Yu

CONTACT

+86-021-64175590; xiaoliyu@fudan.edu.cn

Jin Meng

CONTACT

+86 18121299532; jinmeng@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 29, 2022
• Study Start: March 1, 2021
• Primary Completion: December 25, 2023
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)