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.
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.
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.
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.
Cohort
Prospective
Individualized therapy
Other interventionThis 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.
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.
Overall Survival (OS)
Time interval from the date of confirmed local breast cancer recurrence to death from any cause.
Secondary Local Recurrence Rate
Percentage of participants who develop secondary local lesion recurrence during follow-up period.
Distant Metastasis Rate
Percentage of participants who develop systemic distant metastasis during follow-up period.
Incidence of Treatment-Related Adverse Events
Percentage of participants experiencing adverse events during post-recurrence anti-tumor treatment.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
