Breast NeoplasmsPhase 2NCT05479409
Neoadjuvant Radiation in Locally Advanced Breast Cancer
A Phase 2 study testing Neoadjuvant radiotherapy, β-alanine and Spatially fractionated radiotherapy in people with Breast Neoplasms, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Neoadjuvant radiotherapy, β-alanine and Spatially fractionated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiaoli Yu, xiaoliyu@fudan.edu.cn
About this study
Official title: Effect of Neoadjuvant Radiation and Prediction of Response to Treatment 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 microenvironmental features and molecular biomarkers associated with treatment response, radioresistance, immune activation, and long-term outcomes.
Read the detailed description
RATIONALE:
The optimal management of patients with locally advanced breast cancer(LABC) remains unknown. Neoadjuvant chemotherapy is currently accepted as a standard treatment strategy for patients with inoperable LABC; however, a substantial proportion of patients do not achieve sufficient tumor regression and may remain unsuitable for surgery. For these patients, radiation therapy before surgery may provide an opportunity for further tumor downstaging, improve the chance of surgical conversion, and enhance local-regional control.
OUTLINE:
This is a prospective, open-label, multi-arm phase II study. Eligible patients are women with inoperable locally advanced breast cancer who remain unsuitable for surgery following 2-6 courses of neoadjuvant chemotherapy.
Patients will receive one of the following treatment strategies: neoadjuvant radiation therapy, beta-alanine supplementation plus neoadjuvant radiation therapy, or spatially fractionated radiotherapy.
The primary objective of this study is to evaluate the clinical efficacy of these radiation-based strategies, including local-regional control and surgical conversion. Secondary objectives include treatment safety, tumor response, pathological response when surgery is performed, and long-term clinical outcomes.
This study will also investigate early predictors of treatment response. Fresh tumor tissue and peripheral blood samples will be collected and stored before treatment for biomarker analysis. Molecular and tumor microenvironmental characteristics associated with radiotherapy sensitivity, radioresistance, immune activation, and treatment outcomes will be explored. Imaging assessments will be performed before and after treatment, and ultrasound-based parameters, including shear wave elastography, will be evaluated as potential early imaging predictors of treatment response.
- Conditions
- Breast Neoplasms
- Being tested
- Neoadjuvant radiotherapy, β-alanine, Spatially fractionated radiotherapy
- Keywords
- breast cancer, neoadjuvant radiotherapy, biomarkers
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant radiotherapyRadiation
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-alanineDietary supplement
β-alanine, 1.7g, tid, p.o
Spatially fractionated radiotherapyRadiation
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 group | Role | What they receive |
|---|---|---|
| Neoadjuvant radiotherapy | Experimental | Not described Receives: Radiation: Neoadjuvant radiotherapy |
| β-alanine plus neoadjuvant radiotherapy | Experimental | Not described Receives: Radiation: Neoadjuvant radiotherapy; Dietary Supplement: β-alanine |
| Spatially fractionated radiotherapy | Experimental | Not described Receives: Radiation: Spatially fractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response rate
only for operable patients
Measured: 1 year
Fbjective response rate(ORR)
for inoperable patients
Measured: 3 year
Event free survival(EFS)
for all patients
Measured: 3 year
Secondary outcomes (2)
Time to progression
including local-regional recurrence, disease-free survival, overall survival
Measured: 3 year
Radiation Toxicity
using CTCAE 4.0 and RTOG classification
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Mar 2021
- Primary completion25 Dec 2023
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoli Yu, Fudan University
- Investigators
- Xiaoli Yu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479409
- Sponsor's protocol ID
- FDRT-BC016
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2022
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neoadjuvant Radiation and Prediction of Response to Treatment in Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05479409
- Acronym / sponsor ID
- FDRT-BC016
- Conditions
- Breast Neoplasms
- Keywords
- breast cancer, neoadjuvant radiotherapy, biomarkers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RATIONALE:
The optimal management of patients with locally advanced breast cancer(LABC) remains unknown. Neoadjuvant chemotherapy is currently accepted as a standard treatment strategy for patients with inoperable LABC; however, a substantial proportion of patients do not achieve sufficient tumor regression and may remain unsuitable for surgery. For these patients, radiation therapy before surgery may provide an opportunity for further tumor downstaging, improve the chance of surgical conversion, and enhance local-regional control.
OUTLINE:
This is a prospective, open-label, multi-arm phase II study. Eligible patients are women with inoperable locally advanced breast cancer who remain unsuitable for surgery following 2-6 courses of neoadjuvant chemotherapy.
Patients will receive one of the following treatment strategies: neoadjuvant radiation therapy, beta-alanine supplementation plus neoadjuvant radiation therapy, or spatially fractionated radiotherapy.
The primary objective of this study is to evaluate the clinical efficacy of these radiation-based strategies, including local-regional control and surgical conversion. Secondary objectives include treatment safety, tumor response, pathological response when surgery is performed, and long-term clinical outcomes.
This study will also investigate early predictors of treatment response. Fresh tumor tissue and peripheral blood samples will be collected and stored before treatment for biomarker analysis. Molecular and tumor microenvironmental characteristics associated with radiotherapy sensitivity, radioresistance, immune activation, and treatment outcomes will be explored. Imaging assessments will be performed before and after treatment, and ultrasound-based parameters, including shear wave elastography, will be evaluated as potential early imaging predictors of treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant radiotherapyThe 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. | Radiation | Neoadjuvant radiotherapy, β-alanine plus neoadjuvant radiotherapy |
| β-alanineβ-alanine, 1.7g, tid, p.o | Dietary supplement | β-alanine plus neoadjuvant radiotherapy |
| Spatially fractionated radiotherapySpatially 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. | Radiation | Spatially fractionated radiotherapy |
Primary outcome
Pathological response rate
Time frame: 1 year
only for operable patients
Fbjective response rate(ORR)
Time frame: 3 year
for inoperable patients
Event free survival(EFS)
Time frame: 3 year
for all patients
2 secondary outcomes
Time to progression
Time frame: 3 year
Radiation Toxicity
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoli Yu principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant radiotherapy, β-alanine and Spatially fractionated radiotherapy in people with Breast Neoplasms, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Yu (+86-021-64175590, xiaoliyu@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological response rate (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.