Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer

Multicenter (Phase II) Study of Oncoplastic Surgical Techniques for Breast Conservation in Breast Cancers

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00870415

Enrollment

263

Registered

2009-03-27

Start date

2007-04-30

Completion date

2010-12-31

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIC breast cancer, ductal breast carcinoma, invasive ductal breast carcinoma

Brief summary

RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. PURPOSE: This phase II trial is studying different breast-conserving surgery techniques in treating women with breast cancer.

Detailed description

OBJECTIVES: Primary * Evaluate the percentage of histologically healthy margins maintained during resection in women with breast cancer. Secondary * Evaluate local recurrence at 5 years. * Evaluate aesthetic results. * Evaluate quality of life using the QLQC30 and BR23 questionnaires. OUTLINE: This is a multicenter study. Patients undergo oncoplastic conservative surgery according to defined modalities across the various centers. Quality of life is assessed periodically. After completion of study treatment, patients are followed every 6 months for 2 years and then for at least 3 years.

Interventions

PROCEDUREquality-of-life assessment

PROCEDUREtherapeutic conventional surgery

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 120 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Diagnosis of intraductal breast cancer requiring a wide local resection * Diagnosis of infiltrating ductal breast cancer within range * Diagnosis of invasive breast cancer that has not responded well to neoadjuvant treatment * No multicentric tumor * No gigantomastia * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * No patients subject to a measure of legal protection or unable to express consent * No patients deprived of liberty by judicial or administrative decision or hospitalized without patient consent * Not pregnant or nursing PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the diseased breast * No prior adjuvant treatment * No concurrent participation in another clinical research study

Design outcomes

Primary

Measure	Time frame
Percentage of histologically healthy margins maintained during resection	From inclusion to end of intervention

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026