E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study will include patients with genetic predisposition to development of breast cancer, who are offered prophylactic bilateral skin-sparring mastectomy. |
Studiet vil inkludere patienter, der er arveligt disponerede til at udvikle brystkræft, som tilbydes en profylaktisk hudbesparende bilateral mastektomi. |
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E.1.1.1 | Medical condition in easily understood language |
Women with a predisposition to breast cancer who are offered removal of the breast tissue. |
Kvinder med arvelig disponering til brystkræft, der vil blive tilbudt operativ fjernelse af brystet. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10071981 |
E.1.2 | Term | BRCA2 gene mutation |
E.1.2 | System Organ Class | 10018065 - General disorders and administration site conditions |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10071980 |
E.1.2 | Term | BRCA1 gene mutation |
E.1.2 | System Organ Class | 10018065 - General disorders and administration site conditions |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The addition of ex-vivo expanded Adipose Derived-Stem Cells (ASC) can improve volume retention of fat grafts for breast reconstruction following mastectomy. |
Formålet med forsøget er at bruge stamceller fra fedtvæv til at øge overlevelsen af fedttransplantater, som bruges til brystrekonstruktion efter mastektomi. |
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E.2.2 | Secondary objectives of the trial |
It is hypothesized that the improvement of fat graft volume retention can decrease the number of treatments needed for complete reconstruction. |
Målet er at nedbringe antallet af kirurgiske indgreb med fedttransplantation som skal anvendes til brystrekonstruktion. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age 25 - 45 years (25 and 45 included) 2. Females who are offered prophylactic, bilateral nipple-sparring mastectomy due to an estimated familial predisposition to develop breast cancer. 3. Patients who are deemed fit for breast reconstruction with fat grafting by a plastic surgeon in terms of available fat supply, breast symmetry and small, non-ptotic breast mound. 4. Signed informed consent by the patient 5. Mutual agreement on acceptable breast volume for point of complete reconstruction between patient and surgeon.
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E.4 | Principal exclusion criteria |
1. Smoking. 2. Diabetes or other comorbidities that may increase the risk of surgical complications assessed by the surgeon. 3. Genetic syndromes associated with high risk of cancers other than breast- and ovarian cancer. 4. Previous- or planned radiotherapy. 5. Asymmetry of the breasts or thorax. 6. Pacemaker or other implanted foreign objects in the vicinity of the breast.
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E.5 End points |
E.5.1 | Primary end point(s) |
Graft retention of the total volume of injected grafts one year after the final reconstructive procedure, determined by MRI of the breast. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Six months and one year after complete reconstruction of the breasts. |
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E.5.2 | Secondary end point(s) |
1. Number of treatments needed for complete breast reconstruction. 2. Radiological changes in the breast after conventional and stem cell-enriched fat injection based on MRI one year after ended treatment with fat grafting to the breast. 3. Graft retention rate of the first, second and any subsequent grafting sessions.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Six months and one year after complete reconstruction of the breasts. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last patient will be 12 months after complete breast reconstruction. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |