Breast CancerNCT06938360
Clinical Efficacy and Safety Assessment of Breast-Conserving Surgery for Central Breast Cancer: A Prospective Randomized Controlled Trial
A study testing breast-conserving surgery combined with radiotherapy in people with Breast Cancer, run by Xijing Hospital at 1 site in China.
Trial summary
This study enrolled 158 patients with primary central early-stage breast cancer and randomly assigned them to two groups. The control group underwent total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction), while the experimental group received breast-conserving surgery combined… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- breast-conserving surgery combined with radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2025to 20 Feb 2030
- Phase
- Interventional
- 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
- Female patients aged 18-70 years with primary breast cancer;
- Histopathologically confirmed invasive breast cancer (meeting latest ASCO/CAP guidelines criteria) with:
- TNM stage T1-2;
- Nodal stage N0-1;
- Ductal carcinoma in situ (DCIS) with maximum tumor diameter <3 cm;
- Paget's disease;
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- Neoadjuvant chemotherapy permitted for eligible patients;
- Unicentric lesion confirmed by breast ultrasound, mammography, and MRI;
- Nipple-areolar complex resection required for preoperative imaging or pathologically confirmed nipple involvement;
- Enrolled patients randomized 1:1 to breast-conserving surgery or total mastectomy group;
- Participants voluntarily signed informed consent forms and completed ethics review procedures.
Who cannot join
- Tumor-related characteristics
- Metastatic or bilateral breast cancer
- Inflammatory breast cancer
- Multicentric lesions
- Comorbidities/treatment history
- History of other malignancies (except cured cervical carcinoma in situ/basal cell carcinoma/squamous cell carcinoma) or prior anticancer therapy (systemic/local)
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- Major non-breast surgery within 4 weeks before enrollment (excluding diagnostic biopsy/PICC placement) without full recovery
- Active infections/immune disorders:
- HIV/AIDS Viral hepatitis (HBV-DNA≥500 IU/ml; HCV antibody-positive with detectable HCV-RNA) Autoimmune hepatitis HBV/HCV coinfection
- Allogeneic bone marrow/solid organ transplantation history or planned
- Cardiovascular diseases:
- Heart failure or LVEF<50%
- Uncontrolled arrhythmias (resting heart rate>100 bpm, ventricular tachycardia, Mobitz II/third-degree AV block)
- Angina requiring antianginal drugs
- Clinically significant valvulopathy
- Transmural myocardial infarction on ECG
- Uncontrolled hypertension (SBP>180 mmHg and/or DBP>100 mmHg)
- Reproductive status
- Pregnancy/lactation, or reproductive-aged women with:
- Positive baseline pregnancy test
- Refusal of effective contraception
- Neuropsychiatric disorders Epilepsy, dementia, psychoactive substance abuse, or alcoholism
- Other investigator-determined exclusionary conditions
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
Xijing hospital
Xi'an, Shaanxi, 710032
Ju liang J L Zhang, 029-84775271, vascularzhang@163.com
About this study
This study enrolled 158 patients with primary central early-stage breast cancer and randomly assigned them to two groups. The control group underwent total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction), while the experimental group received breast-conserving surgery combined with radiotherapy (nipple resection with concurrent nipple reconstruction and oncoplastic surgery when nipple involvement was present; conversion to total mastectomy required for intraoperative or postoperative positive margins). The primary endpoint was local recurrence rate, with secondary endpoints including disease-free survival (DFS), overall survival (OS), patient-reported outcomes (PRO), and surgery-related complications.
Read the detailed description
This prospective, open-label, multicenter, randomized clinical trial plans to enroll 158 patients with primary central early-stage breast cancer. Participants will be randomly assigned to two groups: the control group undergoing total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction), and the experimental group receiving breast-conserving surgery with radiotherapy (nipple resection with concurrent nipple reconstruction and oncoplastic surgery when nipple involvement is present; conversion to total mastectomy required for intraoperative or postoperative positive margins). All enrolled patients will initiate surgical treatment within 24 hours after eligibility confirmation. Experimental group patients must complete preoperative breast ultrasound, mammography, and MRI to assess breast-conserving feasibility. All patients receive standardized adjuvant therapy (chemotherapy, endocrine therapy, targeted therapy, and immunotherapy) according to guidelines. Those meeting neoadjuvant therapy criteria may receive preoperative systemic treatments (chemotherapy, endocrine therapy, targeted therapy, and immunotherapy), excluding neoadjuvant radiotherapy.
Primary Endpoint:
local recurrence rate
Secondary Endpoints:
disease-free survival (DFS), overall survival (OS), patient-reported outcomes (PRO), and surgery-related complications.
Inclusion Criteria:
- Female patients aged 18-70 years with primary breast cancer;
- Histopathologically confirmed invasive breast cancer (meeting latest ASCO/CAP guidelines criteria) with:
- TNM stage T1-2;
- Nodal stage N0-1;
- Ductal carcinoma in situ (DCIS) with maximum tumor diameter <3 cm;
- Paget's disease;
- Neoadjuvant chemotherapy permitted for eligible patients;
- Unicentric lesion confirmed by breast ultrasound, mammography, and MRI;
- Nipple-areolar complex resection required for preoperative imaging or pathologically confirmed nipple involvement;
- Enrolled patients randomized 1:1 to breast-conserving surgery or total mastectomy group;
- Participants voluntarily signed informed consent forms and completed ethics review procedures.
- Conditions
- Breast Cancer
- Being tested
- breast-conserving surgery combined with radiotherapy
- Keywords
- breast-conserving surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast-conserving surgery combined with radiotherapyProcedure or surgery
The experimental group received breast-conserving surgery combined with radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction) | No intervention | Prosthetic implantation or autologous tissue transfer reconstruction was permitted |
| breast-conserving surgery combined with radiotherapy | Experimental | nipple resection with concurrent nipple reconstruction and oncoplastic surgery when nipple involvement was present; conversion to total mastectomy required for intraoperative or postoperative positive margins Receives: Procedure: breast-conserving surgery combined with radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence rate (LRR)
Local recurrence rate (LRR) was defined as tumor recurrence in the ipsilateral breast, chest wall, skin, or surgical scar area.
Measured: From enrollment to 3 years later or death
Secondary outcomes (3)
Disease-free survival (DFS)
Disease-free survival (DFS) was defined as the time from randomization to the first occurrence of any of the following events: ipsilateral/contralateral breast cancer recurrence; local/regional recurrence; distant metastasis; or all-cause death.
Measured: From enrollment to 3 years later or death
Overall survival (OS)
Overall survival (OS) was defined as the time interval from enrollment to all-cause death.
Measured: From enrollment to 3 years later or death
Patient-reported outcomes (PRO)
Patient-reported outcomes (PRO) were assessed using the BREAST-Q Cosmetic Module, with scores ranging from 0 to 100 (higher scores indicating better cosmetic outcomes).
Measured: From enrollment to 3 years later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start20 Feb 2025
- Primary completion20 Feb 2028 (estimated)
- Study completion20 Feb 2030 (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 Xijing HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study enrolled 158 patients with primary central early-stage breast cancer and randomly assigned them to two groups. The control group underwent total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction), while the experimental group received breast-conserving surgery combined with radiotherapy (nipple resection with concurrent nipple reconstruction and oncoplastic surgery when nipple involvement was present; conversion to total mastectomy required for intraoperative or postoperative positive margins).
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shaanxi Provincial People's Hospital, Tang-Du Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938360
- Sponsor's protocol ID
- KY20242433-F-1
- Status last verified
- Feb 2025
- First submitted
- 14 Apr 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety Assessment of Breast-Conserving Surgery for Central Breast Cancer: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06938360
- Acronym / sponsor ID
- KY20242433-F-1
- Conditions
- Breast Cancer
- Keywords
- breast-conserving surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Shaanxi Provincial People's Hospital, Tang-Du Hospital
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 20 Feb 2028 (estimated)
- Study completion
- 20 Feb 2030 (estimated)
- First posted
- 22 Apr 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 enrolled 158 patients with primary central early-stage breast cancer and randomly assigned them to two groups. The control group underwent total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction), while the experimental group received breast-conserving surgery combined with radiotherapy (nipple resection with concurrent nipple reconstruction and oncoplastic surgery when nipple involvement was present; conversion to total mastectomy required for intraoperative or postoperative positive margins). The primary endpoint was local recurrence rate, with secondary endpoints including disease-free survival (DFS), overall survival (OS), patient-reported outcomes (PRO), and surgery-related complications.
Detailed description
This prospective, open-label, multicenter, randomized clinical trial plans to enroll 158 patients with primary central early-stage breast cancer. Participants will be randomly assigned to two groups: the control group undergoing total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction), and the experimental group receiving breast-conserving surgery with radiotherapy (nipple resection with concurrent nipple reconstruction and oncoplastic surgery when nipple involvement is present; conversion to total mastectomy required for intraoperative or postoperative positive margins). All enrolled patients will initiate surgical treatment within 24 hours after eligibility confirmation. Experimental group patients must complete preoperative breast ultrasound, mammography, and MRI to assess breast-conserving feasibility. All patients receive standardized adjuvant therapy (chemotherapy, endocrine therapy, targeted therapy, and immunotherapy) according to guidelines. Those meeting neoadjuvant therapy criteria may receive preoperative systemic treatments (chemotherapy, endocrine therapy, targeted therapy, and immunotherapy), excluding neoadjuvant radiotherapy.
Primary Endpoint:
local recurrence rate
Secondary Endpoints:
disease-free survival (DFS), overall survival (OS), patient-reported outcomes (PRO), and surgery-related complications.
Inclusion Criteria:
- Female patients aged 18-70 years with primary breast cancer;
- Histopathologically confirmed invasive breast cancer (meeting latest ASCO/CAP guidelines criteria) with:
- TNM stage T1-2;
- Nodal stage N0-1;
- Ductal carcinoma in situ (DCIS) with maximum tumor diameter <3 cm;
- Paget's disease;
- Neoadjuvant chemotherapy permitted for eligible patients;
- Unicentric lesion confirmed by breast ultrasound, mammography, and MRI;
- Nipple-areolar complex resection required for preoperative imaging or pathologically confirmed nipple involvement;
- Enrolled patients randomized 1:1 to breast-conserving surgery or total mastectomy group;
- Participants voluntarily signed informed consent forms and completed ethics review procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study enrolled 158 patients with primary central early-stage breast cancer and randomly assigned them to two groups. The control group underwent total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction), while the experimental group received breast-conserving surgery combined with radiotherapy (nipple resection with concurrent nipple reconstruction and oncoplastic surgery when nipple involvement was present; conversion to total mastectomy required for intraoperative or postoperative positive margins).
| Arm | Type | Receives |
|---|---|---|
| Total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction) | No intervention | –Prosthetic implantation or autologous tissue transfer reconstruction was permitted |
| breast-conserving surgery combined with radiotherapy | Experimental | Procedure: breast-conserving surgery combined with radiotherapynipple resection with concurrent nipple reconstruction and oncoplastic surgery when nipple involvement was present; conversion to total mastectomy required for intraoperative or postoperative positive margins |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female patients aged 18-70 years with primary breast cancer;
- Histopathologically confirmed invasive breast cancer (meeting latest ASCO/CAP guidelines criteria) with:
- Ductal carcinoma in situ (DCIS) with maximum tumor diameter <3 cm;
- Paget's disease;
- Neoadjuvant chemotherapy permitted for eligible patients;
Key exclusion criteria (23 listed)
- Tumor-related characteristics
- Comorbidities/treatment history
- HIV/AIDS Viral hepatitis (HBV-DNA≥500 IU/ml; HCV antibody-positive with detectable HCV-RNA) Autoimmune hepatitis HBV/HCV coinfection
- Reproductive status
- Neuropsychiatric disorders Epilepsy, dementia, psychoactive substance abuse, or alcoholism
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 |
|---|---|---|
| breast-conserving surgery combined with radiotherapyThe experimental group received breast-conserving surgery combined with radiotherapy | Procedure or surgery | breast-conserving surgery combined with radiotherapy |
Primary outcome
Local recurrence rate (LRR)
Time frame: From enrollment to 3 years later or death
Local recurrence rate (LRR) was defined as tumor recurrence in the ipsilateral breast, chest wall, skin, or surgical scar area.
3 secondary outcomes
Disease-free survival (DFS)
Time frame: From enrollment to 3 years later or death
Overall survival (OS)
Time frame: From enrollment to 3 years later or death
Patient-reported outcomes (PRO)
Time frame: From enrollment to 3 years later
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 22 Apr 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 study testing breast-conserving surgery combined with radiotherapy in people with Breast Cancer, run by Xijing Hospital 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 11 inclusion and 23 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 22 Apr 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.
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 Ju liang J L Zhang (029-84775271, vascularzhang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence rate (LRR) (time frame: From enrollment to 3 years later or death). 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 22 Apr 2025.