Factors Influencing Breast Cancer Resection Volumes And Their Impact on Treatment Outcome (FIBRATIO)

NCT05257577 | Active Not Recruiting

• 1 other identifier: R21052
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 4

Brief Summary

The number of breast cancer survivors is constantly growing. Breast conserving surgery (BCS) is equal or superior to mastectomy both regarding survival and quality of life (QoL). Hence, as many patients as possible should be treated using BCS. The results indicate that the rate of mastectomies in Finland is higher than in Europe, while the rate of reoperations due to insufficient margins after BCS is lower in Finland than globally. With this study we aim to identify the optimal balance of radicality and tissue-conservation in BCS. The aim of this study is to measure the volume of the resected breast tissue and the width of the healthy tissue margins and to compare these with the radiological and histological tumor size and with the size of the breast and their correlation with theoretically optimal and excised volumes. This is a national prospective multicenter study conducted in five breast units. 250 women with primary, unilateral, cTis-T2 breast cancer eligible for BCS will be recruited. The diagnostics and treatment of the patients will be carried out following the Finnish national guideline. The size of the breast and the radiological size of the tumor will be measured preoperatively using mammograms and MRI. The histological tumor volume and the resection volume will be measured postoperatively. The optimal resection volume is calculated as the difference of the total resection volume and the volume of the tumor with an added 1 cm margin. To map the impact of the treatment on QoL and body image, the patients are surveyed using EORTC-QLQ-C30 and BREAST-Q Breast Conserving Therapy Module QoL questionnaires preoperatively, 3-8 weeks postoperatively, and two years after the radiotherapy. Objective evaluation of the aesthetic outcome is assessed by the BCCT.core software that uses medical photographs taken at the same time points as the questionnaires are filled.

Conditions

Breast Cancer; Quality of Life; Patient Satisfaction; Resection Margin; Surgical Margin; Multidisciplinary Communication

Keywords

breast conserving surgery; quality of life; resection margin; resection volume; reoperation rate

Outcome Measures

Primary Outcomes (3)

• Breast-related quality of life assessed by EORTC QLQ-C30, BREAST-Q Version 2.0 Breast Conserving Therapy Module and BCCT.core

  What is the effect of breast-related QoL and objective aesthetic outcome, as measured by two QoL questionnires and with BCCT.core, of the treatment on patient's overall QoL?

  2-3 years

• Differences in resection volumes (cm3) and patient reported outcomes between surgeons and breast units

  Are there differences in resection volumes and patient-related outcomes between surgeons or breast centers?

  2 years

• Calculated resection rate

  The ratio of theoretically optimal and excised resection volume for the tumor

  2 months

Secondary Outcomes (4)

• Radiotherapy effects on the breast assessed by bilateral breast volume measurement by mammogram, and by BCCT.core

  2-3 years

• Significance of the multidisciplinary team treatment plan on treatment outcome

  2-3 years

• Reoperation rate

  1-7 months

• Effect of the tumor subtype, tumor size, DCIS component, tumor palpability or preoperative MRI imaging on the resection margins?

  2 months

Study Arms (1)

Study group

Breast conserving surgery

Procedure: Breast conserving surgery

Interventions

Breast conserving surgery PROCEDURE

Patients receive standard of care breast surgery and subsequent whole breast irradiation

Study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Biological female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Females ages 18 - 80 years of age scheduled to undergo breast conserving surgery and subsequent whole breast radiotherapy for unilateral DCIS or invasive breast cancer

You may qualify if:

• primary, solitary/multifocal, unilateral cTis-T2 breast cancer eligible for BCS
• DCIS, ductal, lobular and other subtypes of invasive breast cancer (excluding LCIS and ADH)
• ASA 1-2 and life expectancy more than 3 years
• mammogram done with a device showing compression thickness
• no previous breast surgery (bilateral reduction mammoplasty or mastopexy accepted)

You may not qualify if:

• metastatic breast cancer
• previous ipsi- or contralateral breast cancer
• bilateral breast cancer
• hereditary breast cancer
• contralateral symmetrization procedure in conjunction with the cancer surgery
• contraindication for radiotherapy
• neoadjuvant treatment
• pregnancy or breastfeeding
• inability to provide informed consent

Sponsors & Collaborators

• Tampere University Hospital: lead
• Jyväskylä Central Hospital: collaborator
• Turku University Hospital: collaborator
• Kuopio University Hospital: collaborator

Study Sites (4)

Hospital Nova of Central Finland

Jyväskylä, 40620, Finland

Location

Kuopio University Hospital

Kuopio, 70210, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (20)

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  BACKGROUND

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  BACKGROUND

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MeSH Terms

Conditions

Breast Neoplasms; Patient Satisfaction; Margins of Excision

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• Niku KJ Oksala, Professor

  Tampere University Hospital, Tampere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 25, 2022
• Study Start: May 28, 2022
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (4)