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Clinical research of modified Skin-preserved radical mastectomy and I/II phase breast reconstruction in patients with stage I and II invasive breast cancer

Clinical research of modified Skin-preserved radical mastectomy and I/II phase breast reconstruction in patients with stage I and II invasive breast cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TNRC-10001276
Enrollment
Unknown
Registered
2010-10-19
Start date
2009-09-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

2:routine modified radical mastectomy
1:routine modified radical mastectomy

Sponsors

West China hospital, SCU
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: NAC+I group (meet each criteria): 1. Single or multiple mass in breast confirmed by Breast high-frequency Doppler and mammography, whose diameter is >=4 cm and 2cm away from nipple; 2. No nipple discharge, erosion or pathologic papillary retraction and invagination. No skin invasion of neoplasm; 3. Hollow needle biopsy showed invasive carcinoma or intraductal carcinoma, negative result of intraoperative frozen section of enlarged lymph node or Sentinel lymph node biopsy; 4. No immune disease; 5. Patients who voluntarily accept breast construction and are able to afford the expense of implantation body and complied the follow-up well; 6. Relative small breast and breast appearance is not satisfying after breast conserving operation. NAC+II group (meet each criteria): 1. Single or multiple mass in breast confirmed by Breast high-frequency Doppler and mammography, whose diameter is >=4 cm and 2cm away from nipple. MRI showed no NAC invasion; 2. No nipple discharge, erosion or pathologic papillary retraction and invagination. No skin invasion of neoplasm; 3. Hollow needle biopsy showed invasive carcinoma or intraductal carcinoma, axillary lymph nodes is less than 4; 4. No immune disease; 5. Abdominal color Doppler, chest x ray or total bone scan show no distant metastasis; 6. Patients who voluntarily accept breast construction and are able to afford the expense of implantation body and complied the follow-up well; 7. Relative small breast and breast appearance is not satisfying after breast conserving operation.Conserving skin and removing nipple I group (meet each criteria) 1. Single or multiple mass in breast confirmed by Breast high-frequency Doppler and mammography, whose diameter is <4 cm and 1-2 cm away from nipple. There is no finding of enlargement or abnormal structure ipsilateral axillary lymph node; 2. No nipple discharge, erosion or pathologic papillary retraction and invagination. No skin invasion of neoplasm. Suspicious or confirmed NAC invasion by MRI; 3. Hollow needle biopsy showed invasive carcinoma or intraductal carcinoma, axillary lymph nodes is less than 4; 4. No immune disease; 5. Abdominal color Doppler, chest x ray or total bone scan show no distant metastasis.

Exclusion criteria

Exclusion criteria: 1. Abdominal color Doppler, chest x ray or total bone scan showed distant metastasis; 2. Inflammatory breast cancer; 3. Immune disease; 4. Tumor invaded skin except nipple and areola papillaris.

Design outcomes

Primary

MeasureTime frame
3 yrs and 5 yrs local tumor recurrent rate, tumor-free survival, quality of life and total survival;

Secondary

MeasureTime frame
Self-satisfying score of breast appearance;Complication;

Countries

China

Contacts

Public ContactQing Lv
lqlq1963@163.com+86 028-85422921

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026