Clinical trial · Observational
Prospective Cohort Study of Local Recurrence After Radical Breast Cancer Resection
Clinicopathological Characteristics and Prognosis of Local Recurrence After Radical Mastectomy for Breast Cancer: A Prospective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualized therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer patients with local recurrence after radical surgery
- description
- 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.
- interventionNames
- Other: Individualized therapy
Primary outcomes (2)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- At least 3 years of follow-up
- description
- Time from confirmed local recurrence to first disease progression (secondary local recurrence, regional lymph node metastasis, distant metastasis) or all-cause death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (8)
- BACKGROUNDQu 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
- BACKGROUNDArthur 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. PMID 31750868
- BACKGROUNDCheun 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
- BACKGROUNDDe 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
- BACKGROUNDMahvi 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
- BACKGROUNDHanson 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.