Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients

Local Recurrence of Malignant Tumor of Breast Clinical Trial

Official title:

Prospective Non-randomized Evaluation of Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02376413
• Other study ID #: sysubcr001
• Status: Withdrawn
• Phase: N/A
• First received: February 17, 2015
• Last updated: December 2, 2015
• Start date: March 2015
• Est. completion date: December 2022

Study information

• Verified date: December 2015
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Observational

Clinical Trial Summary

Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast cancer patients. There are evidences indicating that oncoplastic-BCS (displacement technique) could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as traditional BCS does. However, there are no prospective trial comparing oncoplastic-BCS vs. traditional BCS in terms of cosmetic outcomes and oncological safety. In this study, the investigators are going to address this issue by assigning patients into traditional and oncoplastic-BCS group, based on their preference.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Informed consent signed

• ECOG<=2

• Non-metastatic breast cancer patients with unilateral breast cancer confirmed by pathology.

• Operable or operable after neoadjuvant chemotherapy.

• Extensive, diffuse micro-calcifications on mammography before surgery

• No history of breast surgery or breast radiation therapy before.

• Able to follow the standard of care in adjuvant chemotherapy, radiation therapy, endocrine therapy and targeted therapy after surgery.

Exclusion Criteria:

• Multifocal/multicentric diseases noticed before surgery.

• Inflammatory breast cancer or invasive micro-papillary carcinoma of the breast confirmed by pathology before surgery.

• Tumor size > 5 cm revealed by physical examination, Ultrasound or mammography before surgery.

• Tumor size/breast size ratio >0.5 revealed by by physical examination, Ultrasound or mammography before surgery.

• Have other malignant tumors.

• Have severe co-morbidities that compromise the patients' compliance to our protocol, or endanger the patients.

• Participated in other clinical trials.

• Pathologically confirmed metastatic breast cancer, bilateral breast cancer or DCIS patients.

• Patients with any organ failure.

• Pregnancy women

• Patients who desire to have mastectomy before surgery.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Local Recurrence of Malignant Tumor of Breast
• Neoplasms
• Recurrence

Intervention

Procedure:
• Breast surgery
Traditional breast-conserving surgery, oncoplastic breast-conserving surgery or modified radical mastectomy

Drug:
• Chemotherapy or endocrine therapy or Trastuzumab therapy

Radiation:
• Radiation therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harvard/NSABP/RTOG breast cosmesis grading scale		5 years	No
Secondary	Positivity rate of cavity margin		Intraoperatively.	No
Secondary	Local-recurrence free survival		5 years	No
Secondary	Disease free survival		5 years	No
Secondary	Breast Cancer Treatment Outcome Scale (BCTOS)		5 years	No
Secondary	Morbidity		1 year	No