An interventional study of Determination of acceptance and / or rejection of mastectomy in Breast Cancer, sponsored by Central Hospital Saint Quentin. Status unknown at 1 site in France. Open to female participants aged 75 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by Central Hospital Saint Quentin · Not applicable, Interventional, and Diagnostic
Among 1,208 studies in Breast Neoplasms with a site in France — 207 open to participants now, 342 under way, 83 of them phase 3. Breast Neoplasms · France.
Among the 1,208 studies in Breast Neoplasms with a site in France, this one is the 452nd largest by planned enrollment of the 997 interventional ones that give a count, is one of 53 that started in 2016, is one of 339 with no phase, and was the 599th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →207 of the 1,208 studies in Breast Neoplasms with a site in France are open now. Recruiting first, the newest first:
Institut Claudius Regaud · Sites in France
Daiichi Sankyo · Sites in France, United States, Belgium and 5 more countries
Centre Antoine Lacassagne · Sites in France
Institut Bergonié · Sites in France
Institut du Cancer de Montpellier - Val d'Aurelle · Sites in France
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 75 Years to 100 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,208 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 146 · Phase 2 324 · Phase 3 254 · Phase 4 17
First in 1990; this study’s year is marked. 53 started in 2016.
This study's planned enrollment of 174 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 150 across the 997 interventional studies, 200 across the 202 observational. Of the 787 that completed or were terminated, 254 (32%) have results posted.
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449 of 1,208 have an industry lead sponsor. The 10 most frequent:
Central Hospital Saint Quentin is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Central Hospital Saint Quentin has 2 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
80 of the studies in Breast Neoplasms with a site in France that are under way reach primary completion within a year, 19 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT03820830Phase 3ETOP IBCSG Partners FoundationPalbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer | 2026-12 |
| NCT05894239Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer | 2026-12-31 |
| NCT05038735Phase 3Novartis PharmaceuticalsStudy to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. | 2027-01-28 |
| NCT04208178Phase 3Novartis PharmaceuticalsStudy of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation | 2027-02-26 |
Among the 1,208 studies in Breast Neoplasms with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Background :
Breast cancer is a disease that occurs primarily in elderly women: 54057 of breast cancer occurred on women in 2008, 15.2% were between 75 and 84 years and 5.4% were over 85 years. Elderly women cancers care exposes to several problems: the opportunity for screening, knowing that mammography is not recommended after 75 years old, and the level of treatment depending on the background and the existence of weaknesses. It should determine whether patients are in adequate physiological condition to tolerate classical and "complete" treatment or conversely in a precarious state with advanced fragility, justifying only lightened and adapted symptomatic treatment.
Purpose :
The purpose of this research theme is to assess the quality of life of elderly patients who underwent mastectomy for breast cancer. The objectives are:
Abstract :
The total mastectomy allow, oncologically, a more valid treatment than a lumpectomy, in many cases of women suffering from a breast cancer, but its relevance and acceptability are poorly known. Some think that an elderly woman, postmenopausal, is less concerned with her aesthetics and feminine attributes, which would allow her to accept easily the mastectomy.
The research hypothesis is that the acceptability of mastectomy is not good in elderly women
Primary outcome:
Better detection of comorbidity and geriatric syndromes in vulnerable patients Better detection of a degradation of the quality of life at D0 (at diagnosis)
Secondary outcomes:
Better support for quality of life and psychological support after mastectomy (revaluation to 6 months) Integration of patients in the geriatric sector and implementation of regular monitoring Study design: prospective, multicenter
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Assess the determinants of acceptance of mastectomy based on personal background,Measured by questionnaires: self-image (Rosenberg),personal background (level of fragility, self-image),quality of life SF-36, QLQC30,pain (BPI-SF) and Big Five Inventory.
Other: Determination of acceptance and / or rejection of mastectomy
Assess the determinants of rejection of mastectomy based on personal background, Measured by questionnaires: self-image (Rosenberg),personal background (level of fragility, self-image),quality of life SF-36, QLQC30,pain (BPI-SF) and Big Five Inventory.
Other: Determination of acceptance and / or rejection of mastectomy
Blood exams,Participants completed a questionnaire translated in French language : Rosenberg,SF-36, QLQC30, Big Five Inventory,BPI-SF.:-)
Evaluation of quality of life change by SF-36 (The Short Form Health Survey) between baseline and six months
the 36-Item Short Form Health Survey (SF-36). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized monitoring and assessment of care outcomes in adult patients. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability
Time frame: Baseline and 6 months
QLQ-C30 (Global Health Status)
Quality of life (QoL or QOL) is the perceived quality of an individual's daily life, that is, an assessment of their well-being or lack thereof. This includes all emotional, social and physical aspects of the individual's life;All of the scales and single-item measures range in score from 0 to 100.
Time frame: Baseline and 6 months
Psychological profile
Big Five Inventory (BFI),personality inventory for research settings, minimum = 45 points and maximum scores = 180 points .
Time frame: Baseline and 6 months
Plan to share: No — Participants completed a questionnaire that included the test sociodemographic characteristics and a number of standardized validated instruments translated in French language designed to assess for quality of life and psychological profile. Participants will undergo blood test, electrocardiogram, blood pressure monitoring, geriatric standard evaluation.
No publications or documents are linked to this record.
Started Dec 2016 (actual). Primary completion is estimated for Dec 2020, 48 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 48 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Central Hospital Saint Quentin