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Randomized Controlled Trial of Safety and Aesthetic Outcomes of Breast-conserving Surgery With the Peri-areolar Incision Approach


Phase 3
18 Years
60 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Randomized Controlled Trial of Safety and Aesthetic Outcomes of Breast-conserving Surgery With the Peri-areolar Incision Approach


The Trial aims to determine whether BCS with the peri-areolar approach: 1) is safe in terms
of the rates of recurrence and metastasis; 2) can improve the post-operative aesthetic score
and QOL score.


Inclusion Criteria:



- patients desire for breast conserving surgery;

- fulfills criteria for breast conserving surgery;

- the maximum diameter of the tumor should be less than the semi-perimeter of the
areola and that the proximal margin of tumor should be at least 1 cm away from the
areola;

- patients suitable to receive BCS with either the peri-areolar incision or the
traditional incision were included;

Exclusion Criteria:

- patients not suitable for breast conserving surgery;

- skin or sub-cutaneous tumor invasion as definite contra-indication of skin-sparing;

- male or bilateral breast cancers who might bring up bias in deciding aesthetic
outcomes and expenditure;

- Patients who were supposed to benefit from a certain kind of incision were also
excluded at the researcher's discretion.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

event free survival

Outcome Description:

local recurrence, regional recurrence, distant metastasis, death

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Sun Qiang, Master

Investigator Role:

Study Chair

Investigator Affiliation:

PUMCH

Authority:

China: Ministry of Health

Study ID:

PUMCH- BCS

NCT ID:

NCT01412788

Start Date:

January 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Conserving Surgery
  • Peri-areolar Incision
  • Breast Neoplasms

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