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

NCT ID: NCT02376413

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Local Recurrence of Malignant Tumor of Breast

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Traditional BCS

Breast-conserving surgery. Modified radical mastectomy.

Breast surgery

Intervention Type PROCEDURE

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

Chemotherapy or endocrine therapy or Trastuzumab therapy

Intervention Type DRUG

Radiation therapy

Intervention Type RADIATION

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

Breast surgery

Intervention Type PROCEDURE

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

Chemotherapy or endocrine therapy or Trastuzumab therapy

Intervention Type DRUG

Radiation therapy

Intervention Type RADIATION

Interventions

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Breast surgery

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

Intervention Type PROCEDURE

Chemotherapy or endocrine therapy or Trastuzumab therapy

Intervention Type DRUG

Radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Erwei Song, M.D., Ph.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erwei Song, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Fengxi Su, M.D.

Role: STUDY_DIRECTOR

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

Other Identifiers

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sysubcr001

Identifier Type: -

Identifier Source: org_study_id