NCT02376413

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

7 years

First QC Date

February 17, 2015

Last Update Submit

December 2, 2015

Conditions

Local Recurrence of Malignant Tumor of Breast

Keywords

MorbidityThe Breast Cancer Treatment Outcome ScaleDisease free survivalPositivity cavity margin rateHarvard/NSABP/RTOG breast cosmesis grading scale

Outcome Measures

Primary Outcomes (1)

  • Harvard/NSABP/RTOG breast cosmesis grading scale

    5 years

Secondary Outcomes (5)

  • Positivity rate of cavity margin

    Intraoperatively.

  • Local-recurrence free survival

    5 years

  • Disease free survival

    5 years

  • Breast Cancer Treatment Outcome Scale (BCTOS)

    5 years

  • Morbidity

    1 year

Study Arms (2)

Traditional BCS

Breast-conserving surgery. Modified radical mastectomy.

Procedure: Breast surgeryDrug: Chemotherapy or endocrine therapy or Trastuzumab therapyRadiation: Radiation 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

Procedure: Breast surgeryDrug: Chemotherapy or endocrine therapy or Trastuzumab therapyRadiation: Radiation therapy

Interventions

Breast surgeryPROCEDURE

Traditional breast-conserving surgery, oncoplastic breast-conserving surgery or modified radical mastectomy

Oncoplastic-BCSTraditional BCS
Chemotherapy or endocrine therapy or Trastuzumab therapyDRUG
Oncoplastic-BCSTraditional BCS
Radiation therapyRADIATION
Oncoplastic-BCSTraditional BCS

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Mastectomy, SegmentalDrug TherapyRadiotherapy

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, OperativeTherapeutics

Study Officials

  • Erwei Song, M.D. Ph.D.

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

    PRINCIPAL INVESTIGATOR

  • Fengxi Su, M.D.

    Yat-sen Memorial Hospital, Sun Yat-sen University.

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 17, 2015

First Posted

March 3, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2022

Study Completion

December 1, 2022

Last Updated

December 3, 2015

Record last verified: 2015-12