Prospective Cohort Study of Local Recurrence After Radical Breast Cancer Resection

June 22, 2026 updated by: The First Affiliated Hospital with Nanjing Medical University

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?

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. 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);
  2. Pathologically confirmed isolated local recurrence of breast cancer after primary surgery, without evidence of distant metastasis;
  3. Aged ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and eligible to receive reoperation and subsequent anti-tumor therapy;
  4. Voluntarily participate in this study and provide written informed consent.

Exclusion Criteria:

  1. Presence of concurrent distant metastasis at the time of breast cancer local recurrence;
  2. Severe dysfunction or failure of vital organs (cardiac, hepatic, renal, etc.) that contraindicates reoperation or systemic anti-tumor treatment;
  3. Inability to complete scheduled long-term follow-up as required by the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Individualized therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At least 3 years of follow-up
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.
At least 3 years of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Local Recurrence Rate
Time Frame: At least 3 years of follow-up
Percentage of participants who develop secondary local lesion recurrence during follow-up period.
At least 3 years of follow-up
Distant Metastasis Rate
Time Frame: At least 3 years of follow-up
Percentage of participants who develop systemic distant metastasis during follow-up period.
At least 3 years of follow-up
Incidence of Treatment-Related Adverse Events
Time Frame: At least 3 years of follow-up
Percentage of participants experiencing adverse events during post-recurrence anti-tumor treatment.
At least 3 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 20, 2026

Primary Completion (Estimated)

December 30, 2031

Study Completion (Estimated)

December 30, 2036

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJMU-BC15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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