Prospective Cohort Study of Local Recurrence After Radical Breast Cancer Resection

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Individualized therapy

Treatment groups

100 Participants
are divided into 1 treatment group

Locations

This trial has no locations