Breast CancerNCT07677956
Safety of Breast-Conserving Surgery for Multifocal or Multicentric Breast Cancer
An observational study of Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
The objective of this observational study is to evaluate the oncological safety of breast-conserving surgery combined with standard postoperative radiotherapy in adult female patients diagnosed with multifocal or multicentric breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast-conserving surgery, postoperative radiotherapy and individualized adjuvant systemic therapy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 30 Dec 2036
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This single-center prospective cohort enrolls women aged ≥18 years with an ECOG performance status of 0-1 and pathologically confirmed unilateral multifocal/multicentric breast cancer without distant metastasis. Eligible candidates are suitable for breast-conserving surgery with negative margins and postoperative adjuvant radiotherapy. Patients with inflammatory breast cancer, extensive unresectable lesions, severe vital organ dysfunction, pregnancy or lactation, or poor follow-up compliance will be excluded. All participants provide written informed consent and receive standard routine treatment, with long-term follow-up conducted to observe oncological outcomes, surgical complications and patient-reported quality of life.
Who may be able to join
- Female patients aged ≥18 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Pathologically confirmed invasive breast carcinoma or ductal carcinoma in situ (DCIS);
- Radiologically confirmed unilateral multifocal or multicentric breast cancer;
- No systemic distant metastasis detected on preoperative imaging;
- Comprehensive clinical evaluation predicts all tumor lesions can be completely resected by breast-conserving surgery (BCS) to obtain negative surgical margins, and patients are suitable for standardized adjuvant whole-breast radiotherapy postoperatively;
- Adequate function of vital organs (cardiac, hepatic, renal and hematopoietic systems) to tolerate surgery, subsequent adjuvant radiotherapy and chemotherapy;
- Voluntarily agree to participate in the study after fully understanding the study purpose, procedures, potential risks and benefits, and provide written informed consent.
Who cannot join
- Inflammatory breast cancer;
- Extensive tumor burden that prevents complete resection via breast-conserving surgery or attainment of negative surgical margins;
- Severe dysfunction or failure of vital organs (heart, liver, kidney, lung) making patients unable to tolerate surgery, radiotherapy or chemotherapy;
- Pregnant or lactating women who are ineligible for postoperative radiotherapy;
- Patients who are unwilling or unable to complete long-term postoperative follow-up and data collection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety Evaluation of Breast-Conserving Surgery for Multifocal or Multicentric Breast Cancer: A Prospective Cohort Study
The objective of this observational study is to evaluate the oncological safety of breast-conserving surgery combined with standard postoperative radiotherapy in adult female patients diagnosed with multifocal or multicentric breast cancer. The main questions it aims to answer are:
What is the local recurrence rate and the time distribution of local recurrence after breast-conserving therapy in patients with multifocal or multicentric breast cancer? What independent risk factors are associated with postoperative local recurrence among these patients? There is no separate comparison group in this single-arm prospective cohort study.
Read more
Participants will:
Receive standardized breast-conserving surgery plus routine postoperative radiotherapy and individualized adjuvant therapy in accordance with clinical guidelines; Complete regular clinical follow-up visits, telephone and WeChat follow-ups for at least 3 years after surgery to collect data on surgical complications, tumor recurrence, metastasis and survival status; Fill out standardized questionnaires including Breast-Q, SDS, SAS and EORTC QLQ-C30 to assess postoperative breast satisfaction, psychological status and quality of life.
Read the detailed description
This single-center, single-arm prospective observational cohort study enrolls female patients aged ≥18 years with unilateral multifocal or multicentric breast cancer treated at the Department of Breast Surgery, the First Affiliated Hospital of Nanjing Medical University. Subjects are screened in strict accordance with unified inclusion and exclusion criteria. All enrolled patients receive breast-conserving surgery followed by standardized postoperative radiotherapy and individualized adjuvant therapy without trial-specific interventions, and all treatment regimens are formulated in line with domestic guidelines for breast cancer diagnosis and treatment. All participants sign written informed consent prior to enrollment.
Uniform baseline data including demographic characteristics, menstrual and reproductive history, family history of malignancy, imaging findings, pathological profiles, molecular subtypes, and surgical information are collected. Postoperative 30-day surgical complications are documented to evaluate short-term surgical safety. Standardized long-term follow-up lasting no less than 3 years is conducted after surgery via outpatient visits, telephone calls and WeChat communication to continuously track oncological endpoints such as ipsilateral breast tumor local recurrence, regional lymph node recurrence, contralateral breast malignancy and distant metastasis, as well as data on disease-free survival and overall survival. Validated standardized questionnaires including Breast-Q, SDS, SAS and EORTC QLQ-C30 are administered at scheduled follow-up time points to assess patients' satisfaction with breast appearance, anxiety and depression status, and overall quality of life.
All data are double-entered, subjected to regular quality control and anonymized for privacy protection. Statistical analyses consist of descriptive statistics, univariate analyses, multivariate Logistic regression, Cox proportional hazards regression, and Kaplan-Meier survival analysis. Subgroup analyses stratified by molecular subtype, lesion distribution pattern and axillary lymph node status are performed, and a nomogram predicting the risk of postoperative local recurrence is constructed to facilitate individualized clinical risk assessment.
Patients with inflammatory breast cancer, extensive lesions precluding negative surgical margins, severe vital organ dysfunction, pregnancy or lactation incompatible with radiotherapy, or inability to complete long-term follow-up are excluded from the study. Lost-to-follow-up cases are treated as censored data in survival analyses, and baseline characteristics are compared between lost and fully followed patients to mitigate attrition bias. This study receives no external funding. All study procedures strictly comply with the Declaration of Helsinki and institutional ethical review requirements. The study aims to clarify the oncological safety of comprehensive breast-conserving therapy for multifocal or multicentric breast cancer, identify independent risk factors for postoperative local recurrence, and provide native evidence-based references for individualized surgical management of such patients in China.
- Conditions
- Breast Cancer
- Being tested
- Breast-conserving surgery, postoperative radiotherapy and individualized adjuvant systemic therapy
- Keywords
- Multifocal or multicentric breast cancer, Breast-conserving surgery, Local recurrence
- 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, postoperative radiotherapy and individualized adjuvant systemic therapyOther
All patients receive routine standard clinical treatment rather than investigational interventions, including breast-conserving surgery, axillary staging surgery, postoperative adjuvant radiotherapy, and guideline-concordant chemotherapy, endocrine therapy or anti-HER2 targeted therapy according to pathological and molecular characteristics.
| Study group | Role | What they receive |
|---|---|---|
| Multifocal or Multicentric Breast Cancer Patients Undergoing Breast-Conserving Surgery | This cohort consists of female patients aged ≥18 years with pathologically confirmed unilateral multifocal or multicentric breast cancer who meet all inclusion and exclusion criteria. All participants receive standardized breast-conserving surgery combined with sentinel lymph node biopsy or axillary lymph node dissection as clinically indicated. Postoperatively, all subjects undergo standard adjuvant radiotherapy followed by individualized systemic adjuvant therapy (chemotherapy, endocrine therapy, anti-HER2 targeted therapy) formulated in accordance with national breast cancer clinical guidelines. No investigational interventions are administered, all treatments are routine standard clinical care. Participants will complete long-term follow-up for at least 3 years and finish validated patient-reported outcome (PRO) questionnaires at scheduled visits. Receives: Other: Breast-conserving surgery, postoperative radiotherapy and individualized adjuvant systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence rate of ipsilateral breast
Ipsilateral breast local recurrence rate within 3 years after breast-conserving surgery
Measured: 3 years after surgery
Secondary outcomes (10)
Incidence of postoperative surgical complications
Incidence of short-term complications after surgery, short-term complications (hemorrhage, wound infection, skin flap necrosis) occurring within 30 days after surgery. Long-term upper extremity lymphedema will be monitored for up to 3 years.
Measured: Within 3 years after surgery
Disease-free survival (DFS)
DFS is defined as the time interval from surgery to the first event of tumor recurrence, distant metastasis, or breast cancer-related death.
Measured: 3 years after surgery
Overall survival (OS)
OS is defined as the time from surgery to all-cause death
Measured: At least 3 years after surgery
Regional lymph node recurrence rate
Incidence of ipsilateral axillary regional lymph node recurrence during follow-up
Measured: 3 years after surgery
Contralateral breast malignancy rate
Incidence of new malignant lesions in the contralateral breast
Measured: 3 years after surgery
Distant metastasis rate
Incidence of systemic distant metastasis at any site during follow-up
Measured: 3 years after surgery
Breast-Q patient-reported outcome
Patient-reported breast satisfaction and cosmetic outcomes assessed via the validated Breast-Q questionnaire.
Measured: Baseline, 1 year, 2 years and 3 years after surgery
Self-rating anxiety scale (SAS) score
Anxiety status measured by the validated Self-Rating Anxiety Scale (SAS).
Measured: Baseline, 1 year, 2 years and 3 years after surgery
Self-rating depression scale (SDS) score
Depressive symptoms assessed using the validated Self-Rating Depression Scale (SDS).
Measured: Baseline, 1 year, 2 years and 3 years after surgery
EORTC QLQ-C30 global quality of life score
Overall cancer-related quality of life evaluated with the validated EORTC QLQ-C30 questionnaire.
Measured: Baseline, 1 year, 2 years and 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion30 Dec 2031 (estimated)
- Study completion30 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677956
- Sponsor's protocol ID
- NJMU-BC14
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data involves sensitive personal clinical information of patients, and there is no established data sharing protocol approved by the ethics committee for external researchers at present. Therefore, IPD will not be shared after the study is finished.
Publications
Poenaru MO, Amza M, Toma CV, Augustin FE, Pacu I, Zampieri G, Ples L, Sima RM, Diaconescu AS. Multicentric and Multifocal Breast Tumors-Narrative Literature Review. Cancers (Basel). 2025 Oct 20;17(20):3380. doi: 10.3390/cancers17203380.
PubMed 41154435Sun Y, Gao L, Zhou X, Wang Z, Li Y, Sun Q. Local Recurrence and Survival Outcomes of Multifocal/Multicentric Breast Cancer After Breast Conserving Therapy: A systematic Review and Meta-Analysis. Clin Breast Cancer. 2025 Apr;25(3):e229-e239.e9. doi: 10.1016/j.clbc.2024.10.009. Epub 2024 Oct 18.
PubMed 39542811Masannat YA, Rocco N, Garreffa E, Gulluoglu BM, Kothari A, Maglia A, Nava MB, Omar OS, Potter S, Catanuto G. Global variations in the definition and management of multifocal and multicentric breast cancer: the MINIM international survey. Br J Surg. 2022 Jul 15;109(8):656-659. doi: 10.1093/bjs/znac080. No abstract available.
PubMed 35352093De Lorenzi F, Borelli F, Pagan E, Bagnardi V, Peradze N, Jereczek-Fossa BA, Leonardi C, Mazzarol G, Favia G, Corso G, Montagna E, Rietjens M, Veronesi P. Oncoplastic Breast-Conserving Surgery for Synchronous Multicentric and Multifocal Tumors: Is It Oncologically Safe? A Retrospective Matched-Cohort Analysis. Ann Surg Oncol. 2022 Jan;29(1):427-436. doi: 10.1245/s10434-021-10800-w. Epub 2021 Oct 6.
PubMed 34613536Koppiker C, Joshi S, Mishra R, Kelkar DA, Chigurupati P, Joshi A, John J, Kadu S, Bagdia A, Thakkar D, Deshmukh C, Allampati H, Sharan G, Dhar U, Nare S, Nagarkar S, Busheri L, Varghese B, Pai M. Therapeutic mammoplasty: a "wise" oncoplastic choice-lessons from the largest single-center cohort from Asia. Front Oncol. 2023 Apr 14;13:1131951. doi: 10.3389/fonc.2023.1131951. eCollection 2023.
PubMed 37124516Zhang J, Fang H, Zhao Z, Guo Y, Li Y, Wang Y, Guo X, Ning Z, Wang H. Clinicopathological characteristics and prognostic analysis of multifocal/multicentric breast cancer. Sci Rep. 2025 Dec 29;15(1):44869. doi: 10.1038/s41598-025-28687-y.
PubMed 41462542Tong Y, Sun F, Zhang C, Yang S, Yu Z, Zhao Y. Multifocal/multicentric breast cancer: Does each focus matter? Cancer Med. 2023 Apr;12(7):8815-8824. doi: 10.1002/cam4.5626. Epub 2023 Feb 3.
PubMed 36734288Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.
PubMed 36633525
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation of Breast-Conserving Surgery for Multifocal or Multicentric Breast Cancer: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07677956
- Acronym / sponsor ID
- NJMU-BC14
- Conditions
- Breast Cancer
- Keywords
- Multifocal or multicentric breast cancer, Breast-conserving surgery, Local recurrence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2031 (estimated)
- Study completion
- 30 Dec 2036 (estimated)
- First posted
- 1 Jul 2026 (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 objective of this observational study is to evaluate the oncological safety of breast-conserving surgery combined with standard postoperative radiotherapy in adult female patients diagnosed with multifocal or multicentric breast cancer. The main questions it aims to answer are:
What is the local recurrence rate and the time distribution of local recurrence after breast-conserving therapy in patients with multifocal or multicentric breast cancer? What independent risk factors are associated with postoperative local recurrence among these patients? There is no separate comparison group in this single-arm prospective cohort study.
Participants will:
Receive standardized breast-conserving surgery plus routine postoperative radiotherapy and individualized adjuvant therapy in accordance with clinical guidelines; Complete regular clinical follow-up visits, telephone and WeChat follow-ups for at least 3 years after surgery to collect data on surgical complications, tumor recurrence, metastasis and survival status; Fill out standardized questionnaires including Breast-Q, SDS, SAS and EORTC QLQ-C30 to assess postoperative breast satisfaction, psychological status and quality of life.
Detailed description
This single-center, single-arm prospective observational cohort study enrolls female patients aged ≥18 years with unilateral multifocal or multicentric breast cancer treated at the Department of Breast Surgery, the First Affiliated Hospital of Nanjing Medical University. Subjects are screened in strict accordance with unified inclusion and exclusion criteria. All enrolled patients receive breast-conserving surgery followed by standardized postoperative radiotherapy and individualized adjuvant therapy without trial-specific interventions, and all treatment regimens are formulated in line with domestic guidelines for breast cancer diagnosis and treatment. All participants sign written informed consent prior to enrollment.
Uniform baseline data including demographic characteristics, menstrual and reproductive history, family history of malignancy, imaging findings, pathological profiles, molecular subtypes, and surgical information are collected. Postoperative 30-day surgical complications are documented to evaluate short-term surgical safety. Standardized long-term follow-up lasting no less than 3 years is conducted after surgery via outpatient visits, telephone calls and WeChat communication to continuously track oncological endpoints such as ipsilateral breast tumor local recurrence, regional lymph node recurrence, contralateral breast malignancy and distant metastasis, as well as data on disease-free survival and overall survival. Validated standardized questionnaires including Breast-Q, SDS, SAS and EORTC QLQ-C30 are administered at scheduled follow-up time points to assess patients' satisfaction with breast appearance, anxiety and depression status, and overall quality of life.
All data are double-entered, subjected to regular quality control and anonymized for privacy protection. Statistical analyses consist of descriptive statistics, univariate analyses, multivariate Logistic regression, Cox proportional hazards regression, and Kaplan-Meier survival analysis. Subgroup analyses stratified by molecular subtype, lesion distribution pattern and axillary lymph node status are performed, and a nomogram predicting the risk of postoperative local recurrence is constructed to facilitate individualized clinical risk assessment.
Patients with inflammatory breast cancer, extensive lesions precluding negative surgical margins, severe vital organ dysfunction, pregnancy or lactation incompatible with radiotherapy, or inability to complete long-term follow-up are excluded from the study. Lost-to-follow-up cases are treated as censored data in survival analyses, and baseline characteristics are compared between lost and fully followed patients to mitigate attrition bias. This study receives no external funding. All study procedures strictly comply with the Declaration of Helsinki and institutional ethical review requirements. The study aims to clarify the oncological safety of comprehensive breast-conserving therapy for multifocal or multicentric breast cancer, identify independent risk factors for postoperative local recurrence, and provide native evidence-based references for individualized surgical management of such patients in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multifocal or Multicentric Breast Cancer Patients Undergoing Breast-Conserving Surgery | – | Other: Breast-conserving surgery, postoperative radiotherapy and individualized adjuvant systemic therapyThis cohort consists of female patients aged ≥18 years with pathologically confirmed unilateral multifocal or multicentric breast cancer who meet all inclusion and exclusion criteria. All participants receive standardized breast-conserving surgery combined with sentinel lymph node biopsy or axillary lymph node dissection as clinically indicated. Postoperatively, all subjects undergo standard adjuvant radiotherapy followed by individualized systemic adjuvant therapy (chemotherapy, endocrine therapy, anti-HER2 targeted therapy) formulated in accordance with national breast cancer clinical guidelines. No investigational interventions are administered, all treatments are routine standard clinical care. Participants will complete long-term follow-up for at least 3 years and finish validated patient-reported outcome (PRO) questionnaires at scheduled visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This single-center prospective cohort enrolls women aged ≥18 years with an ECOG performance status of 0-1 and pathologically confirmed unilateral multifocal/multicentric breast cancer without distant metastasis. Eligible candidates are suitable for breast-conserving surgery with negative margins and postoperative adjuvant radiotherapy. Patients with inflammatory breast cancer, extensive unresectable lesions, severe vital organ dysfunction, pregnancy or lactation, or poor follow-up compliance will be excluded. All participants provide written informed consent and receive standard routine treatment, with long-term follow-up conducted to observe oncological outcomes, surgical complications and patient-reported quality of life.
Key inclusion criteria (7 listed)
- Female patients aged ≥18 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Pathologically confirmed invasive breast carcinoma or ductal carcinoma in situ (DCIS);
- Radiologically confirmed unilateral multifocal or multicentric breast cancer;
- No systemic distant metastasis detected on preoperative imaging;
- Comprehensive clinical evaluation predicts all tumor lesions can be completely resected by breast-conserving surgery (BCS) to obtain negative surgical margins, and patients are suitable for standardized adjuvant whole-breast radiotherapy postoperatively;
Key exclusion criteria (5 listed)
- Inflammatory breast cancer;
- Extensive tumor burden that prevents complete resection via breast-conserving surgery or attainment of negative surgical margins;
- Severe dysfunction or failure of vital organs (heart, liver, kidney, lung) making patients unable to tolerate surgery, radiotherapy or chemotherapy;
- Pregnant or lactating women who are ineligible for postoperative radiotherapy;
- Patients who are unwilling or unable to complete long-term postoperative follow-up and data collection.
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, postoperative radiotherapy and individualized adjuvant systemic therapyAll patients receive routine standard clinical treatment rather than investigational interventions, including breast-conserving surgery, axillary staging surgery, postoperative adjuvant radiotherapy, and guideline-concordant chemotherapy, endocrine therapy or anti-HER2 targeted therapy according to pathological and molecular characteristics. | Other | Multifocal or Multicentric Breast Cancer Patients Undergoing Breast-Conserving Surgery |
Primary outcome
Local recurrence rate of ipsilateral breast
Time frame: 3 years after surgery
Ipsilateral breast local recurrence rate within 3 years after breast-conserving surgery
10 secondary outcomes
Incidence of postoperative surgical complications
Time frame: Within 3 years after surgery
Disease-free survival (DFS)
Time frame: 3 years after surgery
Overall survival (OS)
Time frame: At least 3 years after surgery
Regional lymph node recurrence rate
Time frame: 3 years after surgery
Contralateral breast malignancy rate
Time frame: 3 years after surgery
Distant metastasis rate
Time frame: 3 years after surgery
Breast-Q patient-reported outcome
Time frame: Baseline, 1 year, 2 years and 3 years after surgery
Self-rating anxiety scale (SAS) score
Time frame: Baseline, 1 year, 2 years and 3 years after surgery
Self-rating depression scale (SDS) score
Time frame: Baseline, 1 year, 2 years and 3 years after surgery
EORTC QLQ-C30 global quality of life score
Time frame: Baseline, 1 year, 2 years and 3 years after surgery
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 1 Jul 2026.
- Background: PubMed 41154435Poenaru MO, Amza M, Toma CV, Augustin FE, Pacu I, Zampieri G, Ples L, Sima RM, Diaconescu AS. Multicentric and Multifocal Breast Tumors-Narrative Literature Review. Cancers (Basel). 2025 Oct 20;17(20):3380. doi: 10.3390/cancers17203380.
- Background: PubMed 39542811Sun Y, Gao L, Zhou X, Wang Z, Li Y, Sun Q. Local Recurrence and Survival Outcomes of Multifocal/Multicentric Breast Cancer After Breast Conserving Therapy: A systematic Review and Meta-Analysis. Clin Breast Cancer. 2025 Apr;25(3):e229-e239.e9. doi: 10.1016/j.clbc.2024.10.009. Epub 2024 Oct 18.
- Background: PubMed 35352093Masannat YA, Rocco N, Garreffa E, Gulluoglu BM, Kothari A, Maglia A, Nava MB, Omar OS, Potter S, Catanuto G. Global variations in the definition and management of multifocal and multicentric breast cancer: the MINIM international survey. Br J Surg. 2022 Jul 15;109(8):656-659. doi: 10.1093/bjs/znac080. No abstract available.
- Background: PubMed 34613536De Lorenzi F, Borelli F, Pagan E, Bagnardi V, Peradze N, Jereczek-Fossa BA, Leonardi C, Mazzarol G, Favia G, Corso G, Montagna E, Rietjens M, Veronesi P. Oncoplastic Breast-Conserving Surgery for Synchronous Multicentric and Multifocal Tumors: Is It Oncologically Safe? A Retrospective Matched-Cohort Analysis. Ann Surg Oncol. 2022 Jan;29(1):427-436. doi: 10.1245/s10434-021-10800-w. Epub 2021 Oct 6.
- Background: PubMed 37124516Koppiker C, Joshi S, Mishra R, Kelkar DA, Chigurupati P, Joshi A, John J, Kadu S, Bagdia A, Thakkar D, Deshmukh C, Allampati H, Sharan G, Dhar U, Nare S, Nagarkar S, Busheri L, Varghese B, Pai M. Therapeutic mammoplasty: a "wise" oncoplastic choice-lessons from the largest single-center cohort from Asia. Front Oncol. 2023 Apr 14;13:1131951. doi: 10.3389/fonc.2023.1131951. eCollection 2023.
- Background: PubMed 41462542Zhang J, Fang H, Zhao Z, Guo Y, Li Y, Wang Y, Guo X, Ning Z, Wang H. Clinicopathological characteristics and prognostic analysis of multifocal/multicentric breast cancer. Sci Rep. 2025 Dec 29;15(1):44869. doi: 10.1038/s41598-025-28687-y.
- Background: PubMed 36734288Tong Y, Sun F, Zhang C, Yang S, Yu Z, Zhao Y. Multifocal/multicentric breast cancer: Does each focus matter? Cancer Med. 2023 Apr;12(7):8815-8824. doi: 10.1002/cam4.5626. Epub 2023 Feb 3.
- Background: PubMed 36633525Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.
- Individual participant dataSharing planned: No. The individual participant data involves sensitive personal clinical information of patients, and there is no established data sharing protocol approved by the ethics committee for external researchers at present. Therefore, IPD will not be shared after the study is finished.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
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: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 WenBin Zhou, Ph.D (025-68308161, Zhouwenbin@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence rate of ipsilateral breast (time frame: 3 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07677956, which also lists 8 linked publications.
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 1 Jul 2026.