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

Aesthetic Outcomes of Oncoplastic Breast Surgery With a Droplet-Shaped Glandular Flap for Breast Cancer in the Upper Inner Quadrant

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Oncoplastic Breast Surgery; Aesthetic Outcomes
• Intervention / Treatment: Procedure: Oncoplastic technique with a droplet-shaped glandular flap

• Study Type: Interventional
• Enrollment (Anticipated): 109
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shicheng Su, M.D.,Ph.D.; Phone Number: +8613631304227; Email: sushch@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Shicheng Su

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Oncoplastic technique with a droplet-shaped glandular flap

Procedure: Oncoplastic technique with a droplet-shaped glandular flap; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	half a year to one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: December 12, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2021-KY-124-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No