Clinical trial · Observational
Evaluation of the Prevalence of Pelvic Static Disorders in Women With Localized Breast Cancer
Evaluation of the Prevalence of Pelvic Static Disorders in Women Treated for Localized Breast Cancer During Adjuvant Hormone Therapy.
NCT04515888CI-TRIAL-00054890STATICBREASTcompletedClinicalTrials.gov clinicaltrialsProvenance
- 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)
In this study, investigator propose to assess the prevalence of pelvic static disorders in women undergoing adjuvant hormone therapy for localized breast cancer and to assess the overall quality of life in these patients
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PFDI-20 / PFIQ-7 questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- target population
- description
- The target population of the study consists of breast cancer female patients over 50 years old followed for an invasive carcinoma expressing hormone receptors, non metastatic, undergoing adjuvant hormone therapy.
- interventionNames
- Other: PFDI-20 / PFIQ-7 questionnaires
- label
- control population
- description
- The control group will be composed of patients followed for an in situ carcinoma treated by surgery +/- radiotherapy, without hormone therapy.
- interventionNames
- Other: PFDI-20 / PFIQ-7 questionnaires
Primary outcomes (1)
- measure
- Evaluate the prevalence of pelvic static disorders in patients treated for localized breast cancer and undergoing adjuvant hormone therapy (Hormontherapy +).
- timeFrame
- Day 1
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Women with Age ≥ 50 years * Menopaused * Patient followed for carcinoma in situ or infiltrating the breast with or without hormone therapy * Patient who was treated by surgery after June 2015, whether or not followed by radiotherapy or chemotherapy. * Patient who agreed, after receiving information, to participate to the study. Exclusion Criteria: * Metastatic breast cancer * Patient with a history of pelvic static surgery * Patient with a history of pelvic irradiation * Patient unable or unwilling to complete the questionnaires * Patient with a history of urinary incontinence treatment * Patient not affiliated to the French social security system * Subject under tutelage, curatorship or safeguard of justice, * Patient in an emergency situation, * Patient whose regular monitoring is impossible for psychological, family, social or geographical reasons, * Pregnant and / or breastfeeding woman.
References
Publications (14)
- RESULTCowppli-Bony A, Colonna M, Ligier K, Jooste V, Defossez G, Monnereau A; le Reseau Francim; Reseau des registres de cancer Francim. [Descriptive epidemiology of cancer in metropolitan France: Incidence, survival and prevalence]. Bull Cancer. 2019 Jul-Aug;106(7-8):617-634. doi: 10.1016/j.bulcan.2018.11.016. Epub 2019 Mar 2. French. PMID 30833045
- RESULTJones SE, Cantrell J, Vukelja S, Pippen J, O'Shaughnessy J, Blum JL, Brooks R, Hartung NL, Negron AG, Richards DA, Rivera R, Holmes FA, Chittoor S, Whittaker TL, Bordelon JH, Ketchel SJ, Davis JC, Ilegbodu D, Kochis J, Asmar L. Comparison of menopausal symptoms during the first year of adjuvant therapy with either exemestane or tamoxifen in early breast cancer: report of a Tamoxifen Exemestane Adjuvant Multicenter trial substudy. J Clin Oncol. 2007 Oct 20;25(30):4765-71. doi: 10.1200/JCO.2007.10.8274. PMID 17947724
- RESULTKelley C. Estrogen and its effect on vaginal atrophy in post-menopausal women. Urol Nurs. 2007 Feb;27(1):40-5. PMID 17390926
- RESULTChin SN, Trinkaus M, Simmons C, Flynn C, Dranitsaris G, Bolivar R, Clemons M. Prevalence and severity of urogenital symptoms in postmenopausal women receiving endocrine therapy for breast cancer. Clin Breast Cancer. 2009 May;9(2):108-17. doi: 10.3816/CBC.2009.n.020. PMID 19433392
- RESULTSousa MS, Peate M, Jarvis S, Hickey M, Friedlander M. A clinical guide to the management of genitourinary symptoms in breast cancer survivors on endocrine therapy. Ther Adv Med Oncol. 2017 Apr;9(4):269-285. doi: 10.1177/1758834016687260. Epub 2017 Jan 31. PMID 28491147
- RESULTRobinson PJ, Bell RJ, Christakis MK, Ivezic SR, Davis SR. Aromatase Inhibitors Are Associated With Low Sexual Desire Causing Distress and Fecal Incontinence in Women: An Observational Study. J Sex Med. 2017 Dec;14(12):1566-1574. doi: 10.1016/j.jsxm.2017.09.018. Epub 2017 Oct 21. PMID 29066307