Breast CancerNCT07668362
Prospective Cohort Study of Local Recurrence After Radical Breast Cancer Resection
An observational study of Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
The goal of this observational study is to analyze clinicopathological characteristics and identify independent prognostic risk factors, as well as compare treatment outcomes in female patients aged ≥18 years with pathologically confirmed local recurrence of breast cancer after radical surgery (breast-conserving… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Individualized therapy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This single-center prospective observational cohort enrolls female patients aged ≥18 years from the Department of Breast Surgery, Jiangsu Provincial People's Hospital. Eligible participants previously received breast-conserving surgery or total mastectomy for pathologically confirmed invasive breast carcinoma or ductal carcinoma in situ (DCIS), with newly pathologically proven isolated local breast cancer recurrence and no distant metastasis. Subjects must have ECOG performance status 0 or 1 to tolerate salvage reoperation and anti-tumor therapy, and sign written informed consent voluntarily. Patients are excluded if they have concurrent distant metastasis at recurrence, severe cardiac, hepatic, renal or other vital organ dysfunction that prevents treatment, or fail to comply with long-term follow-up.
Who may be able to join
- Patients with a prior history of breast-conserving surgery or total mastectomy, with postoperative pathological diagnosis of invasive breast carcinoma or ductal carcinoma in situ (DCIS);
- Pathologically confirmed isolated local recurrence of breast cancer after primary surgery, without evidence of distant metastasis;
- Aged ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and eligible to receive reoperation and subsequent anti-tumor therapy;
- Voluntarily participate in this study and provide written informed consent.
Who cannot join
- Presence of concurrent distant metastasis at the time of breast cancer local recurrence;
- Severe dysfunction or failure of vital organs (cardiac, hepatic, renal, etc.) that contraindicates reoperation or systemic anti-tumor treatment;
- Inability to complete scheduled long-term follow-up as required by the study.
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: Clinicopathological Characteristics and Prognosis of Local Recurrence After Radical Mastectomy for Breast Cancer: A Prospective Cohort Study
The goal of this observational study is to analyze clinicopathological characteristics and identify independent prognostic risk factors, as well as compare treatment outcomes in female patients aged ≥18 years with pathologically confirmed local recurrence of breast cancer after radical surgery (breast-conserving surgery or total mastectomy) without distant metastasis. The main questions it aims to answer are:
What clinical and pathological factors independently affect progression-free survival (PFS) and overall survival (OS) of breast cancer patients with postoperative local recurrence? Do clinical features and long-term prognosis differ between patients with local recurrence after breast-conserving surgery and those after total mastectomy? Can we identify optimal individualized treatment regimens and suitable populations for re-breast-conserving surgery and postoperative radiotherapy after R0 resection?
Read more
Participants will:
Provide complete baseline demographic, initial clinicopathological, primary surgical and adjuvant treatment data, local recurrence lesion characteristics and post-recurrence treatment information via standardized case report forms; Undergo routine clinical examinations, imaging reviews and pathological rechecks as standard clinical practice; Receive standardized follow-up for at least 3 years through outpatient visits supplemented by telephone/WeChat contact to record disease progression, secondary local recurrence, distant metastasis, all-cause death and treatment adverse events.
Read the detailed description
This is a single-center, prospective, non-interventional cohort study. It aims to analyze the clinicopathological characteristics of female patients with isolated local recurrence without distant metastasis after radical breast cancer surgery, identify independent prognostic risk factors affecting progression-free survival (PFS) and overall survival (OS), compare the clinical features and long-term prognostic differences between patients with local recurrence after breast-conserving surgery and those after total mastectomy, and explore eligible populations and optimal individualized treatment strategies after local recurrence. Female patients treated at the Department of Breast Surgery, Jiangsu Provincial People's Hospital, aged ≥18 years, pathologically confirmed to have postoperative local breast cancer recurrence without distant metastasis, tolerant to anti-tumor therapy and capable of completing full follow-up will be consecutively enrolled, and all subjects will sign informed consent forms. Baseline demographic data, primary clinicopathological information, initial surgical and adjuvant treatment records, characteristics of recurrent lesions, and comprehensive treatment data after local recurrence will be uniformly collected to establish a standardized electronic database with double-data entry for quality control. Standardized follow-up of at least 3 years will be conducted starting from the date of confirmed local recurrence, mainly through outpatient reexaminations supplemented by telephone and WeChat follow-up. Endpoint events including secondary local recurrence, distant metastasis, all-cause death and treatment-related adverse reactions will be recorded. Statistical analyses will be performed using SPSS 26.0 and R 4.3.0. Kaplan-Meier survival analysis and the Log-rank test will be adopted for univariate prognostic comparison. Multivariate Cox regression and Logistic regression models will be constructed to screen independent influencing factors. Subgroup and interaction analyses will be carried out stratified by initial surgical modality, molecular subtype, recurrence interval and lesion size. A prognostic nomogram prediction model will be developed based on regression models, with its discrimination and calibration validated. This study will not interfere with routine clinical treatment regimens; all patients will receive treatment in accordance with domestic breast cancer guidelines and institutional MDT standards. All research data will be anonymized throughout the study. After follow-up completion, data will be locked uniformly, and multiple imputation and sensitivity analyses will be performed to ensure robust results. The findings of this study can provide prospective evidence for risk stratification, prognostic assessment and the formulation of individualized treatment regimens for breast cancer patients with postoperative local recurrence.
- Conditions
- Breast Cancer
- Being tested
- Individualized therapy
- Keywords
- Breast cancer, Local recurrence, Prospective cohort study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized therapyOther
This is a non-interventional prospective cohort study. No experimental treatments are provided by researchers. All therapeutic interventions are standard salvage therapies formulated by the hospital MDT team following official breast cancer guidelines, including salvage reoperation, postoperative radiotherapy, chemotherapy, endocrine therapy and anti-HER2 targeted therapy. The study only retrospectively collects and compares routine clinical treatment data to explore their associations with patients' survival outcomes, and will not adjust or allocate any treatment plans for participants.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients with local recurrence after radical surgery | This cohort includes female patients aged ≥18 with pathologically confirmed isolated local breast cancer recurrence after radical surgery (breast-conserving surgery or total mastectomy) and no distant metastasis, who can tolerate anti-tumor therapy and complete long-term follow-up. This is a non-interventional prospective cohort without experimental interventions; all patients receive standard salvage therapies per national breast cancer guidelines and hospital MDT rules. Treatments of interest are salvage reoperation, postoperative radiotherapy, chemotherapy, endocrine therapy and anti-HER2 targeted therapy for recurrent lesions. Researchers collect full baseline, primary tumor, surgery and recurrence treatment data, and conduct ≥3 years of follow-up to record PFS, OS, secondary local recurrence, distant metastasis and adverse events. Receives: Other: Individualized therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Time from confirmed local recurrence to first disease progression (secondary local recurrence, regional lymph node metastasis, distant metastasis) or all-cause death.
Measured: At least 3 years of follow-up
Overall Survival (OS)
Time interval from the date of confirmed local breast cancer recurrence to death from any cause.
Measured: At least 3 years of follow-up
Secondary outcomes (3)
Secondary Local Recurrence Rate
Percentage of participants who develop secondary local lesion recurrence during follow-up period.
Measured: At least 3 years of follow-up
Distant Metastasis Rate
Percentage of participants who develop systemic distant metastasis during follow-up period.
Measured: At least 3 years of follow-up
Incidence of Treatment-Related Adverse Events
Percentage of participants experiencing adverse events during post-recurrence anti-tumor treatment.
Measured: At least 3 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start20 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
- NCT07668362
- Sponsor's protocol ID
- NJMU-BC15
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 25 Jun 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
Qu FL, Wu SY, Li JJ, Shao ZM. Ipsilateral breast tumor recurrence after breast-conserving surgery: insights into biology and treatment. Breast Cancer Res Treat. 2023 Nov;202(2):215-220. doi: 10.1007/s10549-023-07071-2. Epub 2023 Aug 1.
PubMed 37528263Arthur DW, Winter KA, Kuerer HM, Haffty B, Cuttino L, Todor DA, Anne PR, Anderson P, Woodward WA, McCormick B, Cheston S, Sahijdak WM, Canaday D, Brown DR, Currey A, Fisher CM, Jagsi R, Moughan J, White JR. Effectiveness of Breast-Conserving Surgery and 3-Dimensional Conformal Partial Breast Reirradiation for Recurrence of Breast Cancer in the Ipsilateral Breast: The NRG Oncology/RTOG 1014 Phase 2 Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):75-82. doi: 10.1001/jamaoncol.2019.4320.
PubMed 31750868Cheun JH, Kim HK, Moon HG, Han W, Lee HB. Locoregional Recurrence Patterns in Patients With Different Molecular Subtypes of Breast Cancer. JAMA Surg. 2023 Aug 1;158(8):841-852. doi: 10.1001/jamasurg.2023.2150.
PubMed 37342035De Rose F, Meduri B, De Santis MC, Ferro A, Marino L, Colciago RR, Gregucci F, Vanoni V, Apolone G, Di Cosimo S, Delaloge S, Cortes J, Curigliano G. Rethinking breast cancer follow-up based on individual risk and recurrence management. Cancer Treat Rev. 2022 Sep;109:102434. doi: 10.1016/j.ctrv.2022.102434. Epub 2022 Jul 1.
PubMed 35933845Mahvi DA, Liu R, Grinstaff MW, Colson YL, Raut CP. Local Cancer Recurrence: The Realities, Challenges, and Opportunities for New Therapies. CA Cancer J Clin. 2018 Nov;68(6):488-505. doi: 10.3322/caac.21498. Epub 2018 Oct 17.
PubMed 30328620Hanson SE, Lei X, Roubaud MS, DeSnyder SM, Caudle AS, Shaitelman SF, Hoffman KE, Smith GL, Jagsi R, Peterson SK, Smith BD. Long-term Quality of Life in Patients With Breast Cancer After Breast Conservation vs Mastectomy and Reconstruction. JAMA Surg. 2022 Jun 1;157(6):e220631. doi: 10.1001/jamasurg.2022.0631. Epub 2022 Jun 8.
PubMed 35416926Rajan KK, Fairhurst K, Birkbeck B, Novintan S, Wilson R, Savovic J, Holcombe C, Potter S. Overall survival after mastectomy versus breast-conserving surgery with adjuvant radiotherapy for early-stage breast cancer: meta-analysis. BJS Open. 2024 May 8;8(3):zrae040. doi: 10.1093/bjsopen/zrae040.
PubMed 38758563Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinicopathological Characteristics and Prognosis of Local Recurrence After Radical Mastectomy for Breast Cancer: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07668362
- Acronym / sponsor ID
- NJMU-BC15
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Local recurrence, Prospective cohort study
- 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
- 20 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2031 (estimated)
- Study completion
- 30 Dec 2036 (estimated)
- First posted
- 25 Jun 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 goal of this observational study is to analyze clinicopathological characteristics and identify independent prognostic risk factors, as well as compare treatment outcomes in female patients aged ≥18 years with pathologically confirmed local recurrence of breast cancer after radical surgery (breast-conserving surgery or total mastectomy) without distant metastasis. The main questions it aims to answer are:
What clinical and pathological factors independently affect progression-free survival (PFS) and overall survival (OS) of breast cancer patients with postoperative local recurrence? Do clinical features and long-term prognosis differ between patients with local recurrence after breast-conserving surgery and those after total mastectomy? Can we identify optimal individualized treatment regimens and suitable populations for re-breast-conserving surgery and postoperative radiotherapy after R0 resection?
Participants will:
Provide complete baseline demographic, initial clinicopathological, primary surgical and adjuvant treatment data, local recurrence lesion characteristics and post-recurrence treatment information via standardized case report forms; Undergo routine clinical examinations, imaging reviews and pathological rechecks as standard clinical practice; Receive standardized follow-up for at least 3 years through outpatient visits supplemented by telephone/WeChat contact to record disease progression, secondary local recurrence, distant metastasis, all-cause death and treatment adverse events.
Detailed description
This is a single-center, prospective, non-interventional cohort study. It aims to analyze the clinicopathological characteristics of female patients with isolated local recurrence without distant metastasis after radical breast cancer surgery, identify independent prognostic risk factors affecting progression-free survival (PFS) and overall survival (OS), compare the clinical features and long-term prognostic differences between patients with local recurrence after breast-conserving surgery and those after total mastectomy, and explore eligible populations and optimal individualized treatment strategies after local recurrence. Female patients treated at the Department of Breast Surgery, Jiangsu Provincial People's Hospital, aged ≥18 years, pathologically confirmed to have postoperative local breast cancer recurrence without distant metastasis, tolerant to anti-tumor therapy and capable of completing full follow-up will be consecutively enrolled, and all subjects will sign informed consent forms. Baseline demographic data, primary clinicopathological information, initial surgical and adjuvant treatment records, characteristics of recurrent lesions, and comprehensive treatment data after local recurrence will be uniformly collected to establish a standardized electronic database with double-data entry for quality control. Standardized follow-up of at least 3 years will be conducted starting from the date of confirmed local recurrence, mainly through outpatient reexaminations supplemented by telephone and WeChat follow-up. Endpoint events including secondary local recurrence, distant metastasis, all-cause death and treatment-related adverse reactions will be recorded. Statistical analyses will be performed using SPSS 26.0 and R 4.3.0. Kaplan-Meier survival analysis and the Log-rank test will be adopted for univariate prognostic comparison. Multivariate Cox regression and Logistic regression models will be constructed to screen independent influencing factors. Subgroup and interaction analyses will be carried out stratified by initial surgical modality, molecular subtype, recurrence interval and lesion size. A prognostic nomogram prediction model will be developed based on regression models, with its discrimination and calibration validated. This study will not interfere with routine clinical treatment regimens; all patients will receive treatment in accordance with domestic breast cancer guidelines and institutional MDT standards. All research data will be anonymized throughout the study. After follow-up completion, data will be locked uniformly, and multiple imputation and sensitivity analyses will be performed to ensure robust results. The findings of this study can provide prospective evidence for risk stratification, prognostic assessment and the formulation of individualized treatment regimens for breast cancer patients with postoperative local recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients with local recurrence after radical surgery | – | Other: Individualized therapyThis cohort includes female patients aged ≥18 with pathologically confirmed isolated local breast cancer recurrence after radical surgery (breast-conserving surgery or total mastectomy) and no distant metastasis, who can tolerate anti-tumor therapy and complete long-term follow-up. This is a non-interventional prospective cohort without experimental interventions; all patients receive standard salvage therapies per national breast cancer guidelines and hospital MDT rules. Treatments of interest are salvage reoperation, postoperative radiotherapy, chemotherapy, endocrine therapy and anti-HER2 targeted therapy for recurrent lesions. Researchers collect full baseline, primary tumor, surgery and recurrence treatment data, and conduct ≥3 years of follow-up to record PFS, OS, secondary local recurrence, distant metastasis and adverse events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This single-center prospective observational cohort enrolls female patients aged ≥18 years from the Department of Breast Surgery, Jiangsu Provincial People's Hospital. Eligible participants previously received breast-conserving surgery or total mastectomy for pathologically confirmed invasive breast carcinoma or ductal carcinoma in situ (DCIS), with newly pathologically proven isolated local breast cancer recurrence and no distant metastasis. Subjects must have ECOG performance status 0 or 1 to tolerate salvage reoperation and anti-tumor therapy, and sign written informed consent voluntarily. Patients are excluded if they have concurrent distant metastasis at recurrence, severe cardiac, hepatic, renal or other vital organ dysfunction that prevents treatment, or fail to comply with long-term follow-up.
Key inclusion criteria (4 listed)
- Patients with a prior history of breast-conserving surgery or total mastectomy, with postoperative pathological diagnosis of invasive breast carcinoma or ductal carcinoma in situ (DCIS);
- Pathologically confirmed isolated local recurrence of breast cancer after primary surgery, without evidence of distant metastasis;
- Aged ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and eligible to receive reoperation and subsequent anti-tumor therapy;
- Voluntarily participate in this study and provide written informed consent.
Key exclusion criteria (3 listed)
- Presence of concurrent distant metastasis at the time of breast cancer local recurrence;
- Severe dysfunction or failure of vital organs (cardiac, hepatic, renal, etc.) that contraindicates reoperation or systemic anti-tumor treatment;
- Inability to complete scheduled long-term follow-up as required by the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized therapyThis is a non-interventional prospective cohort study. No experimental treatments are provided by researchers. All therapeutic interventions are standard salvage therapies formulated by the hospital MDT team following official breast cancer guidelines, including salvage reoperation, postoperative radiotherapy, chemotherapy, endocrine therapy and anti-HER2 targeted therapy. The study only retrospectively collects and compares routine clinical treatment data to explore their associations with patients' survival outcomes, and will not adjust or allocate any treatment plans for participants. | Other | Breast cancer patients with local recurrence after radical surgery |
Primary outcome
Progression-Free Survival (PFS)
Time frame: At least 3 years of follow-up
Time from confirmed local recurrence to first disease progression (secondary local recurrence, regional lymph node metastasis, distant metastasis) or all-cause death.
Overall Survival (OS)
Time frame: At least 3 years of follow-up
Time interval from the date of confirmed local breast cancer recurrence to death from any cause.
3 secondary outcomes
Secondary Local Recurrence Rate
Time frame: At least 3 years of follow-up
Distant Metastasis Rate
Time frame: At least 3 years of follow-up
Incidence of Treatment-Related Adverse Events
Time frame: At least 3 years of follow-up
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 25 Jun 2026.
- Background: PubMed 37528263Qu FL, Wu SY, Li JJ, Shao ZM. Ipsilateral breast tumor recurrence after breast-conserving surgery: insights into biology and treatment. Breast Cancer Res Treat. 2023 Nov;202(2):215-220. doi: 10.1007/s10549-023-07071-2. Epub 2023 Aug 1.
- Background: PubMed 31750868Arthur DW, Winter KA, Kuerer HM, Haffty B, Cuttino L, Todor DA, Anne PR, Anderson P, Woodward WA, McCormick B, Cheston S, Sahijdak WM, Canaday D, Brown DR, Currey A, Fisher CM, Jagsi R, Moughan J, White JR. Effectiveness of Breast-Conserving Surgery and 3-Dimensional Conformal Partial Breast Reirradiation for Recurrence of Breast Cancer in the Ipsilateral Breast: The NRG Oncology/RTOG 1014 Phase 2 Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):75-82. doi: 10.1001/jamaoncol.2019.4320.
- Background: PubMed 37342035Cheun JH, Kim HK, Moon HG, Han W, Lee HB. Locoregional Recurrence Patterns in Patients With Different Molecular Subtypes of Breast Cancer. JAMA Surg. 2023 Aug 1;158(8):841-852. doi: 10.1001/jamasurg.2023.2150.
- Background: PubMed 35933845De Rose F, Meduri B, De Santis MC, Ferro A, Marino L, Colciago RR, Gregucci F, Vanoni V, Apolone G, Di Cosimo S, Delaloge S, Cortes J, Curigliano G. Rethinking breast cancer follow-up based on individual risk and recurrence management. Cancer Treat Rev. 2022 Sep;109:102434. doi: 10.1016/j.ctrv.2022.102434. Epub 2022 Jul 1.
- Background: PubMed 30328620Mahvi DA, Liu R, Grinstaff MW, Colson YL, Raut CP. Local Cancer Recurrence: The Realities, Challenges, and Opportunities for New Therapies. CA Cancer J Clin. 2018 Nov;68(6):488-505. doi: 10.3322/caac.21498. Epub 2018 Oct 17.
- Background: PubMed 35416926Hanson SE, Lei X, Roubaud MS, DeSnyder SM, Caudle AS, Shaitelman SF, Hoffman KE, Smith GL, Jagsi R, Peterson SK, Smith BD. Long-term Quality of Life in Patients With Breast Cancer After Breast Conservation vs Mastectomy and Reconstruction. JAMA Surg. 2022 Jun 1;157(6):e220631. doi: 10.1001/jamasurg.2022.0631. Epub 2022 Jun 8.
- Background: PubMed 38758563Rajan KK, Fairhurst K, Birkbeck B, Novintan S, Wilson R, Savovic J, Holcombe C, Potter S. Overall survival after mastectomy versus breast-conserving surgery with adjuvant radiotherapy for early-stage breast cancer: meta-analysis. BJS Open. 2024 May 8;8(3):zrae040. doi: 10.1093/bjsopen/zrae040.
- Background: PubMed 38572751Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- 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 4 inclusion and 3 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 25 Jun 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?
Progression-Free Survival (PFS) (time frame: At least 3 years of follow-up). 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?
On the ClinicalTrials.gov record for NCT07668362, 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 25 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.