Prospective Cohort Study of Local Recurrence After Radical Breast Cancer Resection

NCT07668362 | Not Yet Recruiting

• 1 other identifier: NJMU-BC15
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Breast Cancer

Keywords

Breast cancer; Local recurrence; Prospective cohort study

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At least 3 years of follow-up

Secondary Outcomes (3)

• Secondary Local Recurrence Rate

  At least 3 years of follow-up

• Distant Metastasis Rate

  At least 3 years of follow-up

• Incidence of Treatment-Related Adverse Events

  At least 3 years of follow-up

Study Arms (1)

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

Interventions

Individualized therapy OTHER

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.

Breast cancer patients with local recurrence after radical surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Related Publications (8)

• 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 BACKGROUND

• 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 Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):75-82. doi: 10.1001/jamaoncol.2019.4320.

  PMID: 31750868 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

WenBin Zhou, Ph.D

CONTACT

025-68308161; zhouwenbin@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 25, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): December 30, 2031
• Study Completion (Estimated): December 30, 2036
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share