Women at high risk of developing breast cancer
Conditions
Interventions
Trade Name: VITAMINA D3 KERN PHARMA solución oleosa
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: COLECALCIFEROL-COLESTEROL
Other descriptive name: COLECALCIFEROL-COLESTEROL
Concentra
Sponsors
José Esteban Castelao Fernández
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women at high risk of developing breast cancer (BC) with at least one of the following criteria: a. - Five-year Gail risk of at least 1.7%, or a calculated risk of at least 5 times the average for their age group (20-29 years - calculated Gail risk of at least 5 years 0.1% 30-39 years - calculated Gail risk of at least 5 years 1.0% 40 and older - calculated Gail risk of at least 5 years 1.7%). b. - Known BRCA1/BRCA2 mutation carrier. c. - Family history of hereditary BC (at least 4 family members with BC at any age / at least 2 first degree relatives under 50 years diagnosed with BC / BC and ovarian cancer (OC) diagnosed in the same relative / at least 2 BC cases and 1 OC case at any age in the family). d. - previous biopsy showing atypical hyperplasia or lobular carcinoma in situ. e. - Women with a history of unilateral DCIS or invasive BC in remission (stage I) who have completed standard systemic therapy and local levels. f. - A history of OC in remission for more than 5 years. 2. Serum creatinine =1500, platelets >=100,000. Hemoglobin >=8.0 g / dl. 4. Baseline mammogram within 6 months prior to study entry with no interpretation of suspicious for malignancy (BIRADS 1-3). 5. SWOG performance less than or equal to 1. 6. All patients must provide written informed consent. 7. Age > 18 years. 8. Patients are not candidates for standard BC reduction strategies (prophylactic oophorectomy, prophylactic mastectomy, tamoxifene, raloxifene). 9. Patients of childbearing potential should be using, during the study period, non-hormonal contraceptive method (condom, diaphragm or non-hormonal IUD). 10. Commitment not to take supplements of vitamin D (other than those of the study). It allows up to 1000 mg Ca / day. 11. No adverse reactions to VD. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Current or within 6 months prior to baseline use of hormonal replacement therapy (antiestrogens, estrogen, SERM's, aromatase inhibitors or progestins, hormonal contraceptives). 2. Chronic and concomitant use of anti-inflammatory drugs (aspirin, ibuprofen, indomethacin, etc.) or COX-2 inhibitors in the 3 months prior to baseline (chronic use is the use of more than 3 times per week). 3. Underlying medical conditions, psychiatric or social barriers that prevent patient treatment. 4. Patients with a history of other invasive malignancies, except nonmelanoma skin cancer, will be excluded if there is evidence of another malignancy within the past 5 years. Patients will also be excluded if their previous cancer treatment is contraindicated with this therapy protocol. 5. Bilateral mastectomy. 6. Ongoing pregnancy or lactation. 7. Participation in another clinical trial with medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. Provide preliminary information on the effects that VD consumption has on cellular atypia and breast cell proliferation, measured in ductal lavage samples. 2. To assess the effects that VD consumption has on the estrogen expression, on the apoptosis and on the angiogenesis-related proteins found in ductal lavage samples. 3. To determine the effects that VD consumption has on circulating hormones and growth factors levels in blood samples. 4. To assess the effects that VD consumption has on lipid peroxidation levels in blood and ductal lavage samples.;Primary end point(s): The main objective of this study is to determine changes in mammographic density. A mammogram will be carried out at the beginning (up to 6 months before study entry) and at the end of the participation in the study (12 months). Mammograms will be evaluated using the method described by Ursin (Ursin et al. 1998) and results will be compared.;Main Objective: Determination of the effects of vitamin D intake on mammographic density in patients at high risk of developing breast cancer.;Timepoint(s) of evaluation of this end point: It will be evaluated at the end of the participation in the study (12 months after the beginning of vitamin D supplementation intake). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objectives of this study will evaluate changes in levels of circulating hormones, growth factors and markers of lipid peroxidation in blood samples (E1, E2, E1S, testosterone, DHEA-S, SHBG, prolactin, FSH, IGF-1 and IGFBP3). These levels will be determined at the beginning, at the end and every six months while participating in the study using chemo/electroluminescence, immunoenzymatic and radioisotopic techniques. Changes in levels of lipid peroxidation markers, cell proliferation and proteins involved in estrogen expression, apoptosis and angiogenesis (PCNA, Ki-67, SPF, cyclin D, caspase-3, bcl-2, p21 , bax, COX-2, VEGF, FGF, EGF, F2-isoprostanes, PS2, cathepsin D, CP15 and apolipoprotein D) will also be evaluated. They will be determined at the beginning and end of study using immunohistochemical and spectrophotometric techniques. Changes in cellular atypia (measured at the beginning and end of study using standard cytological techniques) will also be assesed. Determination of the VD levels will be carried out at the beginning, the end and every 3 months during participation in the study using chemoluminescence techniques.;Timepoint(s) of evaluation of this end point: Changes in levels of circulating hormones, growth factors and markers of lipid peroxidation will be determined by comparing the initial levels with levels at 6 and 12 months after initiation of study participation. Changes in the levels of lipid peroxidation, cell proliferation and protein expression associated with estrogen, apoptosis and angiogenesis as well as changes in cellular atypia will be assessed by comparing the values ??of those markers at the beginning and end of participation in the study. Vitamin D levels will be assessed every three months and compared to the initial ones. | — |
Countries
Spain
Contacts
Public ContactCarmen M. Redondo
Complexo Hospitalario Universitario de Vigo
Outcome results
None listed