Cosmetic and Functional Outcomes After Breast Conserving Surgery

National Institute of Oncology, Hungary

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Radiotherapy; Procedure: Lumpectomy, axillary block dissection, breast conserving surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01496001

NIO-BCS-QoL

Details and patient eligibility

About

The initial aesthetic and functional conditions are recorded with the help of the Breast Cancer Treatment Outcome Scale (BCTOS),an international validated questionnaire, and the Breast Cancer Conservative Treatment - cosmetic results (BCCT.core) validated computer software, allowing for comparison. Determination of the initial quality of life is measured with the European Organisation of Research and Treatment of Cancer - Quality of Life Questionnaire number C30-BR23 (EORTC QoL C30-BR23).

Patients then undergo surgical treatment according to institutional protocols. Following conventional marking of the orientation of the specimen, it is measured by an analytical scale.

Histological examination of the specimen will record the largest diameters, and parameters of the lymph nodes, according to the institutional protocol.

On the 4th week following surgery, assuming that wound healing is completed, patients' data are again recorded in BCTOS, BCCT.core and EORTC QoL C30-BR23. A third set of data are gained after completion of adjuvant radiotherapy, on the 8th postoperative month. Magnetic resonance imaging is performed to assess the volume of the contralateral breast.

Tumor - breast volume ratio is calculated, and matched up with cosmetic results in each quadrant, threshold value in the quadrants, above of which it is not advisable to perform conventional breast conserving surgery due to poor outcomes.

Enrollment: 300 patients

Sex: Female

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• early breast cancer
• unilateral tumor
• tumor size is less than 3 cm

Exclusion criteria

• age over 70
• malignant invasive tumor in the past
• pregnancy
• previous surgical treatment of the breast or axilla
• central breast tumor sizing <3 cm
• a need for mastectomy
• tumor size >3 cm measured by mammography or physical examination
• surgical excisions resulting in positive margins
• surgical or radiotherapeutic complication

Trial design

300 participants in 1 patient group

Cohort

Experimental group

Treatment:

Procedure: Lumpectomy, axillary block dissection, breast conserving surgery

Other: Radiotherapy