Breast AdenocarcinomaPhase 1/2NCT06596018
Assessing Combined SBRT in Breast Cancer Non-Responders to Neoadjuvant Chemotherapy
A Phase 1/2 study testing SBRT and Chemotherapy in people with Breast Adenocarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to assess whether the addition of preoperative stereotactic body radiation therapy (SBRT) can improve pathological complete response (pCR) rates and safety in breast cancer patients who do not respond to initial neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Adenocarcinoma
- What is being tested?
- SBRT and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2024to 20 Sep 2028
- Phase
- Phase 1/2
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed histologic diagnosis of invasive adenocarcinoma of the breast;
- Stage T1-4N+M0 breast cancer (i.e., stages II and III);
- Breast MRI showing no extracapsular extension of lymph node involvement;
- The standard neoadjuvant chemotherapy regimen has been deemed ineffective after two cycles, with disease assessed as stable (SD) or progressive (PD) according to RECIST 1.1 criteria;
- ECOG performance status score of 0-2;
- Screening laboratory values must meet the following criteria:
- White blood cells (WBCs) ≥ 2000/μL ii. Absolute neutrophil count (ANC) ≥ 1500/μL iii. Platelets ≥ 100 x 103/μL iv. Hemoglobin ≥ 11.0 g/dL v. Serum creatinine ≤ 2 mg/dL (or glomerular filtration rate ≥ 40 ml/min) vi. AST ≤ 2.5 x upper limit of normal (ULN) vii. ALT ≤ 2.5 x ULN viii. Total bilirubin within normal limits (except subjects with Gilbert\'s syndrome, who must have total bilirubin \< 3.0 mg/dL) ix. INR ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulant(s) x. Negative HIV screening test xi. Negative screening tests for Hepatitis B and Hepatitis C. Patients with positive results that do not indicate true active or chronic infection may enroll after discussion and consensus agreement by the treating physician and principal investigator.
Who cannot join
- Evidence of metastatic disease;
- Known additional malignancy that is progressing or has required active treatment within the past 3 years；
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug；
- Patients with other concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study；
- Pregnancy or breastfeeding.
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
The Department of Radiation Oncology，the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Ting Zhang, +86-15157125533, zezht@zju.edu.cn
About this study
Official title: Efficacy and Safety Evaluation of Combined Preoperative Radiotherapy in Breast Cancer Patients With No Response to Initial Neoadjuvant Chemotherapy
The goal of this clinical trial is to assess whether the addition of preoperative stereotactic body radiation therapy (SBRT) can improve pathological complete response (pCR) rates and safety in breast cancer patients who do not respond to initial neoadjuvant chemotherapy. The main questions it aims to answer are:
- Can the combination of SBRT with chemotherapy increase pCR rates in non-responders to initial neoadjuvant chemotherapy?
- Does the addition of SBRT to chemotherapy have acceptable safety and tolerability profiles?
Participants in this trial will be early or locally advanced breast cancer patients who have shown no response to two cycles of standard neoadjuvant chemotherapy. They will be randomly assigned to either continue with the standard chemotherapy (control group) or receive SBRT in addition to continuing the standard chemotherapy (intervention group). The primary outcome measures will be pCR rate and breast conservation rate. Secondary outcomes will include 3-year local progression-free survival, overall survival, surgical complications, and treatment toxicities.
Read the detailed description
Neoadjuvant chemotherapy is a crucial component in the comprehensive treatment of breast cancer patients, particularly for those with large initial tumors, axillary lymph node metastasis, HER-2 positive, or triple-negative disease. However, some patients do not achieve the desired pathological complete response (pCR) after neoadjuvant chemotherapy. The CTNeoBC meta-analysis has shown that breast cancer patients who achieve pCR after neoadjuvant therapy have a better prognosis compared to those who do not. Specifically, patients who reach pCR exhibit a recurrence rate of less than 10%, whereas those who fail to achieve pCR may have a recurrence rate as high as 50%. On the other hand, in breast-conserving therapy, patients typically undergo boost radiotherapy targeted at the tumor bed, which is administered after the completion of whole-breast radiotherapy. Existing evidence suggests that advancing the radiotherapy boost to the preoperative period is equally effective and safe. To enhance the treatment outcomes for patients who do not respond to initial standard chemotherapy, the investigators have designed this prospective preliminary study to assess the efficacy and safety of stereotactic body radiation therapy (SBRT) when added to neoadjuvant therapy in this population of chemotherapy non-responders.
This study is a prospective, randomized controlled trial. Patients first undergo standard neoadjuvant chemotherapy, with tumor size evaluated through physical examination or ultrasound after each cycle, and breast MRI for tumor assessment after two cycles. Patients who are assessed as having stable disease (SD) or progressive disease (PD) according to RECIST criteria are considered non-responders to initial neoadjuvant chemotherapy. Participants will be randomly allocated in a 1:1 ratio to either the control group or the intervention group. The control group will continue to follow the original chemotherapy regimen, while the intervention group will receive SBRT treatment. The specific plan for SBRT is to target the primary tumor region with a single dose of 8Gy using 6MV-X rays, administered once a day for three consecutive days. After the completion of SBRT, patients will continue the remaining courses of neoadjuvant chemotherapy. Both groups of patients will subsequently undergo standard surgery based on efficacy assessment, followed by whole-breast hypofractionated radiotherapy 4-6 weeks postoperatively, with a plan of 40-42.5Gy/15-16 fractions, without a boost to the original tumor area.
- Conditions
- Breast Adenocarcinoma
- Being tested
- SBRT, Chemotherapy
- Keywords
- breast cancer, chemo-resistance, neoadjuvant radiation, pCR rate
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Target the primary tumor region with a single dose of 8Gy using 6MV-X rays, administered once a day for three consecutive days.
ChemotherapyDrug
Continue to follow the original chemotherapy regimen（anthracycline and/or taxane based regimens）
| Study group | Role | What they receive |
|---|---|---|
| The control group | Active comparator | Patients in this group will continue to follow the original chemotherapy using anthracycline and/or taxane based regimens, according to their physician's preference and center policy Receives: Drug: Chemotherapy |
| The SBRT-combined group | Experimental | The intervention group will receive SBRT treatment. The specific plan for SBRT is to target the primary tumor region with 24Gy/3. After the completion of SBRT, patients will continue the remaining courses of neoadjuvant chemotherapy. Receives: Radiation: SBRT; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast conservation rate
Breast conservation rate
Measured: Intraoperative
pCR rate
Pathological complete response (pCR), defined by the absence of invasive residual primary tumor in the breast and lymph node.The primary objective of this study is to compare pCR rates after continuing chemotherapy plus SBRT versus continuing chemotherapy alone in patients with non-response to initial 2 cycles of neoadjuvant chemotherapy.
Measured: At the end of chemotherapy up to 21 weeks
Secondary outcomes (2)
3-year PFS
PFS is a measure of the time from the start of treatment until the disease progresses or a recurrence is observed, or until death occurs from any cause.
Measured: 3 years after completion of treatment
Acute and late toxicities
Acute and late toxicities (CTCAE v 4.0)
Measured: At the end of chemotherapy and after surgery and after radiotherapy At the end of chemotherapy and after surgery and after radiotherapy: up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start25 Dec 2024
- Primary completion20 Sep 2027 (estimated)
- Study completion20 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596018
- Sponsor's protocol ID
- Y2024-0756
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Combined Preoperative Radiotherapy in Breast Cancer Patients With No Response to Initial Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT06596018
- Acronym / sponsor ID
- Y2024-0756
- Conditions
- Breast Adenocarcinoma
- Keywords
- breast cancer, chemo-resistance, neoadjuvant radiation, pCR rate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 20 Sep 2027 (estimated)
- Study completion
- 20 Sep 2028 (estimated)
- First posted
- 19 Sep 2024 (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 goal of this clinical trial is to assess whether the addition of preoperative stereotactic body radiation therapy (SBRT) can improve pathological complete response (pCR) rates and safety in breast cancer patients who do not respond to initial neoadjuvant chemotherapy. The main questions it aims to answer are:
- Can the combination of SBRT with chemotherapy increase pCR rates in non-responders to initial neoadjuvant chemotherapy?
- Does the addition of SBRT to chemotherapy have acceptable safety and tolerability profiles?
Participants in this trial will be early or locally advanced breast cancer patients who have shown no response to two cycles of standard neoadjuvant chemotherapy. They will be randomly assigned to either continue with the standard chemotherapy (control group) or receive SBRT in addition to continuing the standard chemotherapy (intervention group). The primary outcome measures will be pCR rate and breast conservation rate. Secondary outcomes will include 3-year local progression-free survival, overall survival, surgical complications, and treatment toxicities.
Detailed description
Neoadjuvant chemotherapy is a crucial component in the comprehensive treatment of breast cancer patients, particularly for those with large initial tumors, axillary lymph node metastasis, HER-2 positive, or triple-negative disease. However, some patients do not achieve the desired pathological complete response (pCR) after neoadjuvant chemotherapy. The CTNeoBC meta-analysis has shown that breast cancer patients who achieve pCR after neoadjuvant therapy have a better prognosis compared to those who do not. Specifically, patients who reach pCR exhibit a recurrence rate of less than 10%, whereas those who fail to achieve pCR may have a recurrence rate as high as 50%. On the other hand, in breast-conserving therapy, patients typically undergo boost radiotherapy targeted at the tumor bed, which is administered after the completion of whole-breast radiotherapy. Existing evidence suggests that advancing the radiotherapy boost to the preoperative period is equally effective and safe. To enhance the treatment outcomes for patients who do not respond to initial standard chemotherapy, the investigators have designed this prospective preliminary study to assess the efficacy and safety of stereotactic body radiation therapy (SBRT) when added to neoadjuvant therapy in this population of chemotherapy non-responders.
This study is a prospective, randomized controlled trial. Patients first undergo standard neoadjuvant chemotherapy, with tumor size evaluated through physical examination or ultrasound after each cycle, and breast MRI for tumor assessment after two cycles. Patients who are assessed as having stable disease (SD) or progressive disease (PD) according to RECIST criteria are considered non-responders to initial neoadjuvant chemotherapy. Participants will be randomly allocated in a 1:1 ratio to either the control group or the intervention group. The control group will continue to follow the original chemotherapy regimen, while the intervention group will receive SBRT treatment. The specific plan for SBRT is to target the primary tumor region with a single dose of 8Gy using 6MV-X rays, administered once a day for three consecutive days. After the completion of SBRT, patients will continue the remaining courses of neoadjuvant chemotherapy. Both groups of patients will subsequently undergo standard surgery based on efficacy assessment, followed by whole-breast hypofractionated radiotherapy 4-6 weeks postoperatively, with a plan of 40-42.5Gy/15-16 fractions, without a boost to the original tumor area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | Active comparator | Drug: ChemotherapyPatients in this group will continue to follow the original chemotherapy using anthracycline and/or taxane based regimens, according to their physician's preference and center policy |
| The SBRT-combined group | Experimental | Radiation: SBRT, Drug: ChemotherapyThe intervention group will receive SBRT treatment. The specific plan for SBRT is to target the primary tumor region with 24Gy/3. After the completion of SBRT, patients will continue the remaining courses of neoadjuvant chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed histologic diagnosis of invasive adenocarcinoma of the breast;
- Stage T1-4N+M0 breast cancer (i.e., stages II and III);
- Breast MRI showing no extracapsular extension of lymph node involvement;
- The standard neoadjuvant chemotherapy regimen has been deemed ineffective after two cycles, with disease assessed as stable (SD) or progressive (PD) according to RECIST 1.1 criteria;
- ECOG performance status score of 0-2;
Key exclusion criteria (5 listed)
- Evidence of metastatic disease;
- Known additional malignancy that is progressing or has required active treatment within the past 3 years；
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug；
- Patients with other concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study；
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| SBRTTarget the primary tumor region with a single dose of 8Gy using 6MV-X rays, administered once a day for three consecutive days. | Radiation | The SBRT-combined group |
| ChemotherapyContinue to follow the original chemotherapy regimen（anthracycline and/or taxane based regimens） | Drug | The SBRT-combined group, The control group |
Primary outcome
Breast conservation rate
Time frame: Intraoperative
Breast conservation rate
pCR rate
Time frame: At the end of chemotherapy up to 21 weeks
Pathological complete response (pCR), defined by the absence of invasive residual primary tumor in the breast and lymph node.The primary objective of this study is to compare pCR rates after continuing chemotherapy plus SBRT versus continuing chemotherapy alone in patients with non-response to initial 2 cycles of neoadjuvant chemotherapy.
2 secondary outcomes
3-year PFS
Time frame: 3 years after completion of treatment
Acute and late toxicities
Time frame: At the end of chemotherapy and after surgery and after radiotherapy At the end of chemotherapy and after surgery and after radiotherapy: up to 30 weeks
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 30 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SBRT and Chemotherapy in people with Breast Adenocarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 7 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 30 Dec 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Ting Zhang (+86-571-87783521, zezht@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast conservation rate (time frame: Intraoperative). The study lists 2 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 30 Dec 2025.