Prospective Cohort Study of Local Recurrence After Radical Breast Cancer Resection

Official title

Clinicopathological Characteristics and Prognosis of Local Recurrence After Radical Mastectomy for Breast Cancer: A Prospective Cohort Study

Overview

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.

Interventions

• 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 pati

Primary outcome measures

• Progression-Free Survival (PFS) [Time frame: At least 3 years of follow-up]
• Overall Survival (OS) [Time frame: At least 3 years of follow-up]

Secondary outcome measures (3)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 37528263
• Arthur 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 PMID 31750868
• Cheun 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. PMID 37342035
• De 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. PMID 35933845
• Mahvi 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. PMID 30328620
• Hanson 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. PMID 35416926
• Rajan 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. PMID 38758563
• Bray 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. PMID 38572751

Identifiers

NCT: NCT07668362 · NJMU-BC15

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗