Breast CancerPhase 2NCT07113613
Prospective Study on Exemption of Tumor Bed Boost Radiotherapy for pCR Patients After Breast Conserving Surgery With Neoadjuvant Therapy
A Phase 2 study testing Exemption from additional radiotherapy on the tumor bed after surgery in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study is a multicenter, single-arm, phase II clinical trial, aiming to evaluate the safety and efficacy of tumor bed dose escalation radiotherapy for patients with primary breast lesions achieving pCR (ypT0) after neoadjuvant chemotherapy and breast-conserving surgery. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Exemption from additional radiotherapy on the tumor bed after surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2031
- 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 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation, good compliance, able to cooperate with the trial observation, and having signed a written informed consent form; (2) Confirmed as invasive cancer through pathological tissue examination, and received baseline breast MR or PET/MR examination before neoadjuvant therapy; (3) Received the standard neoadjuvant treatment plan recommended by the guidelines based on molecular typing; (4) Single lesion, initially diagnosed as cT1-3N0-3a; (5) Underwent breast-conserving surgery, with negative surgical margins and a margin distance of ≥1mm, and achieved pCR of the primary breast lesion after NAC (ypT0); (6) Age 30-75 years, ECOG score 0-1; (7) Met the basic requirements for adjuvant radiotherapy, including basically normal peripheral blood count, no significant abnormalities in heart, liver, and kidney functions, and basically normal electrocardiogram; (8) Had no previous chest radiotherapy.
Who cannot join
- Pregnant women, lactating women, or women with reproductive capacity but without contraceptive measures in place; (2) Known to carry mutated susceptibility genes for breast cancer (including BRCA-1 and BRCA-2); (3) Diagnosed with cT4, N3b-c, bilateral breast cancer, with multiple primary lesions, multicentricity or non-bulky enhancement at the primary site; (4) Not receiving the standard neoadjuvant treatment regimen recommended by guidelines, or the primary breast lesion did not achieve pCR (including ypTis) after NAC; (5) Suffering from other malignant tumors or participating in other clinical trials simultaneously; (6) Unable to start radiotherapy within 8 weeks after breast cancer surgery; (7) Diagnosed with distant metastasis through initial imaging or pathology; (8) Previous history of breast cancer, history of radiotherapy in the neck, chest or ipsilateral axilla; (9) Severe non-tumor-related medical comorbidities affecting the implementation of radiotherapy; (10) Suffering from uncontrollable neurological, mental disorders or mental impairments, with poor compliance and inability to cooperate and describe treatment responses.
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 First Affiliated with Nanjing Medical University (Jiangsu Province People's Hospital)
Nanjing, Jiangsu, 210029
Xinchen Sun, Doctor, 86-13770662828, 13770662828@163.com
About this study
Official title: A Multicenter, Single-arm Phase II Clinical Study on Exempting Tumor Bed Boost Radiotherapy for Patients Achieving pCR After Breast Conserving Surgery With Neoadjuvant Therapy
This study is a multicenter, single-arm, phase II clinical trial, aiming to evaluate the safety and efficacy of tumor bed dose escalation radiotherapy for patients with primary breast lesions achieving pCR (ypT0) after neoadjuvant chemotherapy and breast-conserving surgery.
Read the detailed description
New neoadjuvant chemotherapy (NAC) is mainly used for patients with locally advanced or those who wish to preserve their breast. It not only helps to downstage the tumor but also increases the success rate and possibility of breast-conserving treatment for patients. Moreover, NAC provides doctors with the opportunity to assess the chemotherapy response, which can be used to predict the survival of patients. Studies have shown that patients who achieve pathological complete response (PCR) after NAC and surgery have a lower local-regional recurrence rate, higher disease-free survival rate and overall survival rate. Currently, there are no treatment guidelines for this group of patients. Avoiding unnecessary tumor bed dose escalation can reduce radiotherapy toxicity and help promote the effective utilization of medical resources. This study is the first prospective single-arm study to explore the prognostic significance of NAC and breast-conserving surgery without tumor bed dose escalation for patients with pCR breast cancer. The aim is to identify the appropriate population for exemption from tumor bed dose escalation and to develop more precise adjuvant radiotherapy plans.
- Conditions
- Breast Cancer
- Being tested
- Exemption from additional radiotherapy on the tumor bed after surgery
- Keywords
- Radiotherapy, Exemption of tumor bed dosage increase, Breast-conserving treatment, Neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exemption from additional radiotherapy on the tumor bed after surgeryRadiation
For patients who met the inclusion criteria and were enrolled, postoperative tumor bed boost radiotherapy was waived, and only whole breast and/or regional lymph node irradiation was administered.
| Study group | Role | What they receive |
|---|---|---|
| Exempted tumor bed radiotherapy group | Experimental | The total breast irradiation dose was 43.5 Gy/15 fractions, with each fraction being 2.9 Gy, administered once a day, 5 times a week; the dose for the regional lymph nodes was also 43.5 Gy/15 fractions, with each fraction being 2.9 Gy, administered once a day, 5 times a week. Receives: Radiation: Exemption from additional radiotherapy on the tumor bed after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year ipsilateral breast recurrence rate (IBTR)
The recurrence of the same-sided breast occurred for the first time within 5 years.
Measured: 5 years
5-year local-regional recurrence (LRR)
Recurrence of the same-side breast, the same-side axillary fossa, the same-side supraclavicular lymph nodes, or the same-side internal mammary lymph nodes for the first time within 5 years.
Measured: 5 years
Secondary outcomes (6)
Local regional control rate (LRC)
The time from NAC to the occurrence of the first LRR
Measured: 5 years
Disease-free survival time (DFS)
The time from NAC to recurrence or death
Measured: 5 years
Overall survival time (OS)
The time from chemotherapy to death due to any cause
Measured: 5 years
Safety-related study endpoints
acute or chronic radiotherapy-related adverse reactions: including skin damage, breast pain, lung damage, heart damage, upper limb edema, upper limb functional impairment, brachial plexus injury, etc.
Measured: 5 years
cosmetic effect
evaluation of cosmetic effect after breast-conserving surgery using the Harvard standard.
Measured: 5 years
quality of life evaluation
quality of life evaluation using the Chinese version of the QLQ-BR23 scale.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Xinchen, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Xinchen Sun, Doctor, Principal investigator, The First Affiliated with Nanjing Medical University (Jiangsu Province People's Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113613
- Sponsor's protocol ID
- 2024-SR-983
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm Phase II Clinical Study on Exempting Tumor Bed Boost Radiotherapy for Patients Achieving pCR After Breast Conserving Surgery With Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT07113613
- Acronym / sponsor ID
- 2024-SR-983
- Conditions
- Breast Cancer
- Keywords
- Radiotherapy, Exemption of tumor bed dosage increase, Breast-conserving treatment, Neoadjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 11 Aug 2025 (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.
This study is a multicenter, single-arm, phase II clinical trial, aiming to evaluate the safety and efficacy of tumor bed dose escalation radiotherapy for patients with primary breast lesions achieving pCR (ypT0) after neoadjuvant chemotherapy and breast-conserving surgery.
Detailed description
New neoadjuvant chemotherapy (NAC) is mainly used for patients with locally advanced or those who wish to preserve their breast. It not only helps to downstage the tumor but also increases the success rate and possibility of breast-conserving treatment for patients. Moreover, NAC provides doctors with the opportunity to assess the chemotherapy response, which can be used to predict the survival of patients. Studies have shown that patients who achieve pathological complete response (PCR) after NAC and surgery have a lower local-regional recurrence rate, higher disease-free survival rate and overall survival rate. Currently, there are no treatment guidelines for this group of patients. Avoiding unnecessary tumor bed dose escalation can reduce radiotherapy toxicity and help promote the effective utilization of medical resources. This study is the first prospective single-arm study to explore the prognostic significance of NAC and breast-conserving surgery without tumor bed dose escalation for patients with pCR breast cancer. The aim is to identify the appropriate population for exemption from tumor bed dose escalation and to develop more precise adjuvant radiotherapy plans.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exempted tumor bed radiotherapy group | Experimental | Radiation: Exemption from additional radiotherapy on the tumor bed after surgeryThe total breast irradiation dose was 43.5 Gy/15 fractions, with each fraction being 2.9 Gy, administered once a day, 5 times a week; the dose for the regional lymph nodes was also 43.5 Gy/15 fractions, with each fraction being 2.9 Gy, administered once a day, 5 times a week. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Voluntary participation, good compliance, able to cooperate with the trial observation, and having signed a written informed consent form; (2) Confirmed as invasive cancer through pathological tissue examination, and received baseline breast MR or PET/MR examination before neoadjuvant therapy; (3) Received the standard neoadjuvant treatment plan recommended by the guidelines based on molecular typing; (4) Single lesion, initially diagnosed as cT1-3N0-3a; (5) Underwent breast-conserving surgery, with negative surgical margins and a margin distance of ≥1mm, and achieved pCR of the primary breast lesion after NAC (ypT0); (6) Age 30-75 years, ECOG score 0-1; (7) Met the basic requirements for adjuvant radiotherapy, including basically normal peripheral blood count, no significant abnormalities in heart, liver, and kidney functions, and basically normal electrocardiogram; (8) Had no previous chest radiotherapy.
Key exclusion criteria (1 listed)
- Pregnant women, lactating women, or women with reproductive capacity but without contraceptive measures in place; (2) Known to carry mutated susceptibility genes for breast cancer (including BRCA-1 and BRCA-2); (3) Diagnosed with cT4, N3b-c, bilateral breast cancer, with multiple primary lesions, multicentricity or non-bulky enhancement at the primary site; (4) Not receiving the standard neoadjuvant treatment regimen recommended by guidelines, or the primary breast lesion did not achieve pCR (including ypTis) after NAC; (5) Suffering from other malignant tumors or participating in other clinical trials simultaneously; (6) Unable to start radiotherapy within 8 weeks after breast cancer surgery; (7) Diagnosed with distant metastasis through initial imaging or pathology; (8) Previous history of breast cancer, history of radiotherapy in the neck, chest or ipsilateral axilla; (9) Severe non-tumor-related medical comorbidities affecting the implementation of radiotherapy; (10) Suffering from uncontrollable neurological, mental disorders or mental impairments, with poor compliance and inability to cooperate and describe treatment responses.
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 |
|---|---|---|
| Exemption from additional radiotherapy on the tumor bed after surgeryFor patients who met the inclusion criteria and were enrolled, postoperative tumor bed boost radiotherapy was waived, and only whole breast and/or regional lymph node irradiation was administered. | Radiation | Exempted tumor bed radiotherapy group |
Primary outcome
5-year ipsilateral breast recurrence rate (IBTR)
Time frame: 5 years
The recurrence of the same-sided breast occurred for the first time within 5 years.
5-year local-regional recurrence (LRR)
Time frame: 5 years
Recurrence of the same-side breast, the same-side axillary fossa, the same-side supraclavicular lymph nodes, or the same-side internal mammary lymph nodes for the first time within 5 years.
6 secondary outcomes
Local regional control rate (LRC)
Time frame: 5 years
Disease-free survival time (DFS)
Time frame: 5 years
Overall survival time (OS)
Time frame: 5 years
Safety-related study endpoints
Time frame: 5 years
cosmetic effect
Time frame: 5 years
quality of life evaluation
Time frame: 5 years
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 11 Aug 2025.
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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.
Xinchen Sun, Doctor principal investigator
The First Affiliated with Nanjing Medical University (Jiangsu Province People's Hospital)
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 Exemption from additional radiotherapy on the tumor bed after surgery in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical 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 1 inclusion and 1 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 11 Aug 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 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 Xinchen Sun, Doctor (13770662828, 13770662828@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year ipsilateral breast recurrence rate (IBTR) (time frame: 5 years). 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 11 Aug 2025.