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Aesthetic Outcomes of Oncoplastic Breast Surgery for Breast Cancer in the Upper Inner Quadrant

Primary Purpose

Oncoplastic Breast Surgery, Breast Cancer, Aesthetic Outcomes

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Oncoplastic technique with a droplet-shaped glandular flap
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oncoplastic Breast Surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed the informed consent.
  • Female aged between 18 and 70 years.
  • Pathologically diagnosed operable breast cancer.
  • WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Cancer located in the upper inner quadrant; Single tumor or multiple tumors in the same quadrant.
  • The important organ functions meet the following criteria:
  • WBC >=3.0 x 10^9/L; Neutrophilic granulocytes >=1.5×10^9/L; Platelet >=100 x 10^9/L; Hb >=9 g/dL;
  • Total bilirubin no more than 1.5 times the normal upper limit (ULN); AST and ALT no more than 1.5 times ULN; AKP no more than 2.5 times ULN;
  • Serum creatinine no more than 1.5 times ULN or Clearance rate of creatinine >= 60ml/min;
  • Thyroid stimulating hormone (TSH) <= ULN (T3, T4 levels need to be detected simultaneously if abnormalities, the patient can be included if T3, T4 levels is normal);
  • LVEF basement >= 50%.
  • Adjust to the criteria of breast conserving surgery.

Exclusion Criteria:

  • Multifocal or multicentric disease.
  • Tumor localized in the central quadrant or the distance to the nipple < 2 cm；
  • Diffused calcifications with fine plemorphic or fine linear or fine-linear branching morphology.
  • The ratio of tumor to breast > 20%;
  • The diameter of tumor is up to 4 cm;
  • Women in the early or intermediate stage of pregnancy;
  • Prior history of breast radiation;
  • Any severe comorbidities, inability to give informed consent or unavailability for follow-up.

Sites / Locations

  • Shicheng SuRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oncoplastic technique with a droplet-shaped glandular flap

Arm Description

Outcomes

Primary Outcome Measures

aesthetic outcomes
ABNSW system. The total score was 15 points, outcomes were good when it was 11-14, fair when it was 6-10, and poor when it was 0-5.

Secondary Outcome Measures

Patients' quality of life
EORTC QLQ-C30 questionnaire
Local recurrence
Local recurrence defined as histologic evidence of ductal carcinoma in situ or invasive breast cancer in the ipsilateral breast or chest wall.
Patients complications after surgery
The occurence of scarring, radiation fibrosis, seroma, fat necrosis and infection

Full Information

First Posted
December 12, 2021
Last Updated
February 8, 2022
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05179304
Brief Title
Aesthetic Outcomes of Oncoplastic Breast Surgery for Breast Cancer in the Upper Inner Quadrant
Official Title
Aesthetic Outcomes of Oncoplastic Breast Surgery With a Droplet-Shaped Glandular Flap for Breast Cancer in the Upper Inner Quadrant
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Oncoplastic breast surgery, combining oncological resection with plastic surgical techniques, has emerged as an important surgical strategy to optimize conventional breast-conserving surgery. The upper inner quadrant is one of the most difficult and challenging tumor locations for surgeons to perform oncoplastic breast surgery. There is a pressing need to develop a simple and effective oncoplastic surgical technique to cope with the unfavorable anatomy and location of tumors in the UIQ. Here, we present a new oncoplastic volume displacement technique for UIQ using the DSG flap. This trial was design to estimate the aesthetic outcomes of an oncoplastic technique using a droplet-shaped glandular flap for breast cancer in the upper inner quadrant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncoplastic Breast Surgery, Breast Cancer, Aesthetic Outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oncoplastic technique with a droplet-shaped glandular flap
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Oncoplastic technique with a droplet-shaped glandular flap
Intervention Description
A droplet-shaped glandular flap (DSG) is in a shape of a water drop, with the pedicle at the top of the defect and the base underlying nipple-areolar complex (NAC). It runs from the outer upper quadrant to the center along a line parallel to the radial line. We harvest a DSG flap by dissociating the supplement mammary gland from the lateral of the defect after resection, developing deep to the pectoralis fascia, from the cusp at the defect and the round pore underlying nipple-areolar complex (NAC). The DSG flap was rotated inwards around the cusp, reaching the top of the defect. This tailored redistribution allowed the defects to be "plugged" with the lateral glandular flaps.
Primary Outcome Measure Information:
Title
aesthetic outcomes
Description
ABNSW system. The total score was 15 points, outcomes were good when it was 11-14, fair when it was 6-10, and poor when it was 0-5.
Time Frame
half a year to one year
Secondary Outcome Measure Information:
Title
Patients' quality of life
Description
EORTC QLQ-C30 questionnaire
Time Frame
half a year to one year
Title
Local recurrence
Description
Local recurrence defined as histologic evidence of ductal carcinoma in situ or invasive breast cancer in the ipsilateral breast or chest wall.
Time Frame
half a year to one year
Title
Patients complications after surgery
Description
The occurence of scarring, radiation fibrosis, seroma, fat necrosis and infection
Time Frame
half a year to one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed the informed consent. Female aged between 18 and 70 years. Pathologically diagnosed operable breast cancer. WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Cancer located in the upper inner quadrant; Single tumor or multiple tumors in the same quadrant. The important organ functions meet the following criteria: WBC >=3.0 x 10^9/L; Neutrophilic granulocytes >=1.5×10^9/L; Platelet >=100 x 10^9/L; Hb >=9 g/dL; Total bilirubin no more than 1.5 times the normal upper limit (ULN); AST and ALT no more than 1.5 times ULN; AKP no more than 2.5 times ULN; Serum creatinine no more than 1.5 times ULN or Clearance rate of creatinine >= 60ml/min; Thyroid stimulating hormone (TSH) <= ULN (T3, T4 levels need to be detected simultaneously if abnormalities, the patient can be included if T3, T4 levels is normal); LVEF basement >= 50%. Adjust to the criteria of breast conserving surgery. Exclusion Criteria: Multifocal or multicentric disease. Tumor localized in the central quadrant or the distance to the nipple < 2 cm； Diffused calcifications with fine plemorphic or fine linear or fine-linear branching morphology. The ratio of tumor to breast > 20%; The diameter of tumor is up to 4 cm; Women in the early or intermediate stage of pregnancy; Prior history of breast radiation; Any severe comorbidities, inability to give informed consent or unavailability for follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shicheng Su, M.D.,Ph.d.
Phone
+8613631304227
Email
sushch@mail.sysu.edu.cn
Facility Information:
Facility Name
Shicheng Su
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shicheng Su, M.D., Ph.D.
Phone
+86 13631304227
Email
sushch@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Aesthetic Outcomes of Oncoplastic Breast Surgery for Breast Cancer in the Upper Inner Quadrant

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