Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 2:25 AM
Study NCT ID:
NCT06938360
Status:
RECRUITING
Last Update Posted:
2025-04-22
First Post:
2025-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy and Safety Assessment of Breast-Conserving Surgery for Central Breast Cancer: A Prospective Randomized Controlled Trial
Sponsor:
Xijing Hospital
Organization:
Study Overview
Official Title:
Clinical Efficacy and Safety Assessment of Breast-Conserving Surgery for Central Breast Cancer: A Prospective Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study enrolled 158 patients with primary central early-stage breast cancer and randomly assigned them to two groups. The control group underwent total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction), while the experimental group received breast-conserving surgery combined with radiotherapy (nipple resection with concurrent nipple reconstruction and oncoplastic surgery when nipple involvement was present; conversion to total mastectomy required for intraoperative or postoperative positive margins). The primary endpoint was local recurrence rate, with secondary endpoints including disease-free survival (DFS), overall survival (OS), patient-reported outcomes (PRO), and surgery-related complications.
Detailed Description:
This prospective, open-label, multicenter, randomized clinical trial plans to enroll 158 patients with primary central early-stage breast cancer. Participants will be randomly assigned to two groups: the control group undergoing total mastectomy (with optional prosthetic implantation or autologous tissue reconstruction), and the experimental group receiving breast-conserving surgery with radiotherapy (nipple resection with concurrent nipple reconstruction and oncoplastic surgery when nipple involvement is present; conversion to total mastectomy required for intraoperative or postoperative positive margins). All enrolled patients will initiate surgical treatment within 24 hours after eligibility confirmation. Experimental group patients must complete preoperative breast ultrasound, mammography, and MRI to assess breast-conserving feasibility. All patients receive standardized adjuvant therapy (chemotherapy, endocrine therapy, targeted therapy, and immunotherapy) according to guidelines. Those meeting neoadjuvant therapy criteria may receive preoperative systemic treatments (chemotherapy, endocrine therapy, targeted therapy, and immunotherapy), excluding neoadjuvant radiotherapy.
Primary Endpoint:
local recurrence rate
Secondary Endpoints:
disease-free survival (DFS), overall survival (OS), patient-reported outcomes (PRO), and surgery-related complications.
Inclusion Criteria:
1. Female patients aged 18-70 years with primary breast cancer;
2. Histopathologically confirmed invasive breast cancer (meeting latest ASCO/CAP guidelines criteria) with:
* TNM stage T1-2;
* Nodal stage N0-1;
3. Ductal carcinoma in situ (DCIS) with maximum tumor diameter \<3 cm;
4. Paget's disease;
5. Neoadjuvant chemotherapy permitted for eligible patients;
6. Unicentric lesion confirmed by breast ultrasound, mammography, and MRI;
7. Nipple-areolar complex resection required for preoperative imaging or pathologically confirmed nipple involvement;
8. Enrolled patients randomized 1:1 to breast-conserving surgery or total mastectomy group;
9. Participants voluntarily signed informed consent forms and completed ethics review procedures.
Primary Endpoint:
local recurrence rate
Secondary Endpoints:
disease-free survival (DFS), overall survival (OS), patient-reported outcomes (PRO), and surgery-related complications.
Inclusion Criteria:
1. Female patients aged 18-70 years with primary breast cancer;
2. Histopathologically confirmed invasive breast cancer (meeting latest ASCO/CAP guidelines criteria) with:
* TNM stage T1-2;
* Nodal stage N0-1;
3. Ductal carcinoma in situ (DCIS) with maximum tumor diameter \<3 cm;
4. Paget's disease;
5. Neoadjuvant chemotherapy permitted for eligible patients;
6. Unicentric lesion confirmed by breast ultrasound, mammography, and MRI;
7. Nipple-areolar complex resection required for preoperative imaging or pathologically confirmed nipple involvement;
8. Enrolled patients randomized 1:1 to breast-conserving surgery or total mastectomy group;
9. Participants voluntarily signed informed consent forms and completed ethics review procedures.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: