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Neoadjuvant Radiation in Locally Advanced Breast Cancer

ConditionBreast Neoplasms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFudan University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • β-alanine

    Dietary supplement

    β-alanine, 1.7g, tid, p.o

  • 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.

Treatment groups

70 Participants
are divided into 3 treatment groups
Group A: Neoadjuvant radiotherapyExperimental treatment 1 intervention
Group B: β-alanine plus neoadjuvant radiotherapyExperimental treatment 2 interventions
Group C: Spatially fractionated radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pathological response rate

only for operable patients

Time frame
1 year
2

Fbjective response rate(ORR)

for inoperable patients

Time frame
3 year
3

Event free survival(EFS)

for all patients

Time frame
3 year

Secondary outcomes

1

Time to progression

including local-regional recurrence, disease-free survival, overall survival

Time frame
3 year
2

Radiation Toxicity

using CTCAE 4.0 and RTOG classification

Time frame
6 months

Other outcomes

1

Biologic predictor for treatment response

biopsies of the original tumor before treatment for future molecular biology studies in LABC

Time frame
before treatment
2

The role of ultrasound in predicting treatment response

shear wave elastography(SWE) technology

Time frame
before and 1 month after treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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