Clinical trial · Observational
Factors Influencing Breast Cancer Resection Volumes And Their Impact on Treatment Outcome (FIBRATIO)
Factors Influencing Breast Cancer Resection Volumes And Their Impact on Treatment Outcome: a Prospective Multicenter Study (FIBRATIO)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Multidisciplinary Communication | — | UNRESOLVED | — |
| Patient Satisfaction | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Resection Margin | — | UNRESOLVED | — |
| Surgical Margin | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast conserving surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study group
- description
- Breast conserving surgery
- interventionNames
- Procedure: Breast conserving surgery
Primary outcomes (3)
- measure
- Breast-related quality of life assessed by EORTC QLQ-C30, BREAST-Q Version 2.0 Breast Conserving Therapy Module and BCCT.core
- timeFrame
- 2-3 years
- description
- 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?
- measure
- Differences in resection volumes (cm3) and patient reported outcomes between surgeons and breast units
- timeFrame
- 2 years
- description
- Are there differences in resection volumes and patient-related outcomes between surgeons or breast centers?
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: * 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
References
Publications (20)
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- BACKGROUNDAgarwal S, Pappas L, Neumayer L, Kokeny K, Agarwal J. Effect of breast conservation therapy vs mastectomy on disease-specific survival for early-stage breast cancer. JAMA Surg. 2014 Mar;149(3):267-74. doi: 10.1001/jamasurg.2013.3049. PMID 24429935
- BACKGROUNDWaljee JF, Hu ES, Ubel PA, Smith DM, Newman LA, Alderman AK. Effect of esthetic outcome after breast-conserving surgery on psychosocial functioning and quality of life. J Clin Oncol. 2008 Jul 10;26(20):3331-7. doi: 10.1200/JCO.2007.13.1375. PMID 18612149
- BACKGROUNDKelsall JE, McCulley SJ, Brock L, Akerlund MTE, Macmillan RD. Comparing oncoplastic breast conserving surgery with mastectomy and immediate breast reconstruction: Case-matched patient reported outcomes. J Plast Reconstr Aesthet Surg. 2017 Oct;70(10):1377-1385. doi: 10.1016/j.bjps.2017.05.009. Epub 2017 May 18. PMID 28712883
- BACKGROUNDCardoso F, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rubio IT, Zackrisson S, Senkus E; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-updagger. Ann Oncol. 2019 Aug 1;30(8):1194-1220. doi: 10.1093/annonc/mdz173. No abstract available. PMID 31161190
- BACKGROUNDVolders JH, Negenborn VL, Haloua MH, Krekel NMA, Jozwiak K, Meijer S, M van den Tol P. Cosmetic outcome and quality of life are inextricably linked in breast-conserving therapy. J Surg Oncol. 2017 Jun;115(8):941-948. doi: 10.1002/jso.24615. Epub 2017 Mar 23. PMID 28334419
- Valero MG, Mallory MA, Losk K, Tukenmez M, Hwang J, Camuso K, Bunnell C, King T, Golshan M. Surgeon Variability and Factors Predicting for Reoperation Following Breast-Conserving Surgery. Ann Surg Oncol. 2018 Sep;25(9):2573-2578. doi: 10.1245/s10434-018-6526-2. Epub 2018 May 21.