Clinical trial NCT05179304: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Oncoplastic Breast Surgery
Breast Cancer
Aesthetic Outcomes
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: aesthetic outcomes
timeFrame: half a year to one year
Secondary outcomes:
measure: Patients' quality of life
timeFrame: half a year to one year
measure: Local recurrence
timeFrame: half a year to one year
measure: Patients complications after surgery
timeFrame: half a year to one year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Shicheng Su
state: Guangdong
Study officials:
References: