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

December 2, 2015 updated by: Erwei Song, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Non-metastatic breast cancer patients received surgical treatment in Sun Yat-sen Memorial Hospital, Sun Yat-sen University. Informed consent must be obtained for all of the included patients.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Traditional BCS
Breast-conserving surgery. Modified radical mastectomy.
Radiation: Radiation therapy
Procedure: Breast surgery
Traditional breast-conserving surgery, oncoplastic breast-conserving surgery or modified radical mastectomy
Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy
Oncoplastic-BCS

Breast-conserving surgery. Modified radical mastectomy. Oncoplastic-BCS based on surgeon preference and/or tumor location.

  • Superior pedicle mammoplasty / inverted T
  • Superior pedicle mammoplasty / V scar
  • Batwing
  • Inferior pedicle mammoplasty
  • Racquet mammoplasty/radial scar
  • vertical-scar mammoplasty
Radiation: Radiation therapy
Procedure: Breast surgery
Traditional breast-conserving surgery, oncoplastic breast-conserving surgery or modified radical mastectomy
Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Harvard/NSABP/RTOG breast cosmesis grading scale
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease free survival
Time Frame: 5 years
5 years
Morbidity
Time Frame: 1 year
1 year
Positivity rate of cavity margin
Time Frame: Intraoperatively.
Intraoperatively.
Local-recurrence free survival
Time Frame: 5 years
5 years
Breast Cancer Treatment Outcome Scale (BCTOS)
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

  • Principal Investigator: Erwei Song, M.D. Ph.D., Sun Yat-sen Memorial Hospital,Sun Yat-sen University
  • Study Director: Fengxi Su, M.D., Yat-sen Memorial Hospital, Sun Yat-sen University.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sysubcr001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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