Breast NeoplasmsNCT00926315
Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation
A study testing calcitriol in people with Breast Neoplasms and Postmenopausal Disorder, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate whether calcitriol supplementation may reduce tumor cell proliferation and influence gene expression profile of breast cancer samples from post-menopausal patients. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms, Postmenopausal Disorder
- What is being tested?
- calcitriol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2007to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women
- Invasive breast carcinoma
- Clinical conditions for breast surgery
- No previous neoadjuvant treatment for breast cancer
- Agreement to take part in the study and sign the informed consent
Who cannot join
- History of hypercalcemia or nephrolithiasis
- Current use of corticosteroids, vitamin D supplementation, HRT
- Previous chemotherapy, hormonotherapy or radiotherapy
- Parathyroid disease
- Absence of clinical condition to receive supplementation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Brasileiro de Controle do Câncer - IBCC
São Paulo, São Paulo, 03102-002
About this study
Official title: Influence of Vitamin D on Gene Expression Profile of Breast Cancer Samples From Post-menopausal Patients
The purpose of this study is to evaluate whether calcitriol supplementation may reduce tumor cell proliferation and influence gene expression profile of breast cancer samples from post-menopausal patients.
Read the detailed description
Women affected by breast cancer present lower 1,25(OH)2D3 or 25(OH)D3 serum levels than unaffected ones. Calcitriol supplementation may be indicated to post-menopausal women to reduce bone loss. Vitamin D has antiproliferative effects in breast cancer cell lines and breast cancer xenografts.
Post-menopausal breast cancer patients will be prescribed calcitriol supplementation, in doses indicated to prevent osteoporosis, while they are submitted to biopsy, staging exams and have their breast surgery scheduled (approximately one month). Tumor dimension and proliferation rate (as determined by Ki67 expression), 25(OH)D3 and/or 1,25(OH)2D3 serum concentration, will be evaluated before and after calcitriol supplementation. Tumor gene expression will be evaluated in samples collected before and after supplementation to analyze the differential profile.
- Conditions
- Breast Neoplasms, Postmenopausal Disorder
- Being tested
- calcitriol
- Keywords
- Breast Neoplasms, Calcitriol, Postmenopausal, Cell Proliferation, Gene Expression Profiling
- Medical subject headings
- Breast Neoplasms, Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcitriolDrug
Also called Rocaltrol
Post menopausal patients will receive Calcitriol 0.50 mcg PO per day for 1 month.
CalcitriolDrug
Also called Rocaltrol
calcitriol 0.25 mcg PO bid
| Study group | Role | What they receive |
|---|---|---|
| calcitriol | Experimental | calcitriol supplementation (0.25 mcg 2x/d) Receives: Drug: calcitriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile
Measured: 30 days
Secondary outcomes (1)
Follow-up for 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startJul 2007
- Primary completionJun 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Brasileiro de Controle do Cancer
- Responsible party
- Principal investigator, Eduardo Carneiro de Lyra, University of Sao Paulo General Hospital
- Investigators
- Maria Aparecida A Koike Folgueira, MD,PhD, Study chair, Faculdade de Medicina - Universidade de São PauloEduardo Carneiro de Lyra, MD, PhD, Principal investigator, Instituto Brasileiro de Controle do CancerYuri N Urata, MSc, Principal investigator, Faculdade de Medicina da Universidade de São PauloMaria Lucia H Katayama, PhD, Principal investigator, Faculdade de Medicina da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926315
- Sponsor's protocol ID
- FMUSPIBCCVD2009
- Other IDs
- CAPPesq 626/06, FAPESP 07/04799-2, IBCC 108/2006/07, CAPPesq 0018/09
- Status last verified
- Oct 2012
- First submitted
- 19 Jun 2009
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
de Lyra EC, da Silva IA, Katayama ML, Brentani MM, Nonogaki S, Goes JC, Folgueira MA. 25(OH)D3 and 1,25(OH)2D3 serum concentration and breast tissue expression of 1alpha-hydroxylase, 24-hydroxylase and Vitamin D receptor in women with and without breast cancer. J Steroid Biochem Mol Biol. 2006 Aug;100(4-5):184-92. doi: 10.1016/j.jsbmb.2006.04.009. Epub 2006 Jul 7.
PubMed 16828283Rozenchan PB, Folgueira MA, Katayama ML, Snitcovsky IM, Brentani MM. Ras activation is associated with vitamin D receptor mRNA instability in HC11 mammary cells. J Steroid Biochem Mol Biol. 2004 Sep;92(1-2):89-95. doi: 10.1016/j.jsbmb.2004.05.007.
PubMed 15544934Katayama ML, Pasini FS, Folgueira MA, Snitcovsky IM, Brentani MM. Molecular targets of 1,25(OH)2D3 in HC11 normal mouse mammary cell line. J Steroid Biochem Mol Biol. 2003 Jan;84(1):57-69. doi: 10.1016/s0960-0760(03)00004-9.
PubMed 12648525Bortman P, Folgueira MA, Katayama ML, Snitcovsky IM, Brentani MM. Antiproliferative effects of 1,25-dihydroxyvitamin D3 on breast cells: a mini review. Braz J Med Biol Res. 2002 Jan;35(1):1-9. doi: 10.1590/s0100-879x2002000100001.
PubMed 11743608Folgueira MA, Federico MH, Katayama ML, Silva MR, Brentani MM. Expression of vitamin D receptor (VDR) in HL-60 cells is differentially regulated during the process of differentiation induced by phorbol ester, retinoic acid or interferon-gamma. J Steroid Biochem Mol Biol. 1998 Aug;66(4):193-201. doi: 10.1016/s0960-0760(98)00041-7.
PubMed 9744516Janjoppi L, Katayama MH, Scorza FA, Folgueira MA, Brentani M, Pansani AP, Cavalheiro EA, Arida RM. Expression of vitamin D receptor mRNA in the hippocampal formation of rats submitted to a model of temporal lobe epilepsy induced by pilocarpine. Brain Res Bull. 2008 Jul 30;76(5):480-4. doi: 10.1016/j.brainresbull.2008.01.002. Epub 2008 Feb 5.
PubMed 18534255Folgueira MA, Carraro DM, Brentani H, Patrao DF, Barbosa EM, Netto MM, Caldeira JR, Katayama ML, Soares FA, Oliveira CT, Reis LF, Kaiano JH, Camargo LP, Vencio RZ, Snitcovsky IM, Makdissi FB, e Silva PJ, Goes JC, Brentani MM. Gene expression profile associated with response to doxorubicin-based therapy in breast cancer. Clin Cancer Res. 2005 Oct 15;11(20):7434-43. doi: 10.1158/1078-0432.CCR-04-0548.
PubMed 16243817
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Vitamin D on Gene Expression Profile of Breast Cancer Samples From Post-menopausal Patients
- ClinicalTrials.gov ID
- NCT00926315
- Acronym / sponsor ID
- FMUSPIBCCVD2009
- Conditions
- Breast Neoplasms, Postmenopausal Disorder
- Keywords
- Breast Neoplasms, Calcitriol, Postmenopausal, Cell Proliferation, Gene Expression Profiling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Instituto Brasileiro de Controle do Cancer
- Study start
- Jul 2007
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether calcitriol supplementation may reduce tumor cell proliferation and influence gene expression profile of breast cancer samples from post-menopausal patients.
Detailed description
Women affected by breast cancer present lower 1,25(OH)2D3 or 25(OH)D3 serum levels than unaffected ones. Calcitriol supplementation may be indicated to post-menopausal women to reduce bone loss. Vitamin D has antiproliferative effects in breast cancer cell lines and breast cancer xenografts.
Post-menopausal breast cancer patients will be prescribed calcitriol supplementation, in doses indicated to prevent osteoporosis, while they are submitted to biopsy, staging exams and have their breast surgery scheduled (approximately one month). Tumor dimension and proliferation rate (as determined by Ki67 expression), 25(OH)D3 and/or 1,25(OH)2D3 serum concentration, will be evaluated before and after calcitriol supplementation. Tumor gene expression will be evaluated in samples collected before and after supplementation to analyze the differential profile.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| calcitriol | Experimental | Drug: calcitriolcalcitriol supplementation (0.25 mcg 2x/d) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal women
- Invasive breast carcinoma
- Clinical conditions for breast surgery
- No previous neoadjuvant treatment for breast cancer
- Agreement to take part in the study and sign the informed consent
Key exclusion criteria (5 listed)
- History of hypercalcemia or nephrolithiasis
- Current use of corticosteroids, vitamin D supplementation, HRT
- Previous chemotherapy, hormonotherapy or radiotherapy
- Parathyroid disease
- Absence of clinical condition to receive supplementation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calcitriolAlso: RocaltrolPost menopausal patients will receive Calcitriol 0.50 mcg PO per day for 1 month. | Drug | calcitriol |
| CalcitriolAlso: Rocaltrolcalcitriol 0.25 mcg PO bid | Drug | calcitriol |
Primary outcome
Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile
Time frame: 30 days
1 secondary outcome
Follow-up for 5 years
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
- Background: PubMed 16828283de Lyra EC, da Silva IA, Katayama ML, Brentani MM, Nonogaki S, Goes JC, Folgueira MA. 25(OH)D3 and 1,25(OH)2D3 serum concentration and breast tissue expression of 1alpha-hydroxylase, 24-hydroxylase and Vitamin D receptor in women with and without breast cancer. J Steroid Biochem Mol Biol. 2006 Aug;100(4-5):184-92. doi: 10.1016/j.jsbmb.2006.04.009. Epub 2006 Jul 7.
- Background: PubMed 15544934Rozenchan PB, Folgueira MA, Katayama ML, Snitcovsky IM, Brentani MM. Ras activation is associated with vitamin D receptor mRNA instability in HC11 mammary cells. J Steroid Biochem Mol Biol. 2004 Sep;92(1-2):89-95. doi: 10.1016/j.jsbmb.2004.05.007.
- Background: PubMed 12648525Katayama ML, Pasini FS, Folgueira MA, Snitcovsky IM, Brentani MM. Molecular targets of 1,25(OH)2D3 in HC11 normal mouse mammary cell line. J Steroid Biochem Mol Biol. 2003 Jan;84(1):57-69. doi: 10.1016/s0960-0760(03)00004-9.
- Background: PubMed 11743608Bortman P, Folgueira MA, Katayama ML, Snitcovsky IM, Brentani MM. Antiproliferative effects of 1,25-dihydroxyvitamin D3 on breast cells: a mini review. Braz J Med Biol Res. 2002 Jan;35(1):1-9. doi: 10.1590/s0100-879x2002000100001.
- Background: PubMed 9744516Folgueira MA, Federico MH, Katayama ML, Silva MR, Brentani MM. Expression of vitamin D receptor (VDR) in HL-60 cells is differentially regulated during the process of differentiation induced by phorbol ester, retinoic acid or interferon-gamma. J Steroid Biochem Mol Biol. 1998 Aug;66(4):193-201. doi: 10.1016/s0960-0760(98)00041-7.
- Background: PubMed 18534255Janjoppi L, Katayama MH, Scorza FA, Folgueira MA, Brentani M, Pansani AP, Cavalheiro EA, Arida RM. Expression of vitamin D receptor mRNA in the hippocampal formation of rats submitted to a model of temporal lobe epilepsy induced by pilocarpine. Brain Res Bull. 2008 Jul 30;76(5):480-4. doi: 10.1016/j.brainresbull.2008.01.002. Epub 2008 Feb 5.
- Background: PubMed 16243817Folgueira MA, Carraro DM, Brentani H, Patrao DF, Barbosa EM, Netto MM, Caldeira JR, Katayama ML, Soares FA, Oliveira CT, Reis LF, Kaiano JH, Camargo LP, Vencio RZ, Snitcovsky IM, Makdissi FB, e Silva PJ, Goes JC, Brentani MM. Gene expression profile associated with response to doxorubicin-based therapy in breast cancer. Clin Cancer Res. 2005 Oct 15;11(20):7434-43. doi: 10.1158/1078-0432.CCR-04-0548.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Aparecida A Koike Folgueira, MD,PhD study chair
Faculdade de Medicina - Universidade de São Paulo
Eduardo Carneiro de Lyra, MD, PhD principal investigator
Instituto Brasileiro de Controle do Cancer
Yuri N Urata, MSc principal investigator
Faculdade de Medicina da Universidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calcitriol in people with Breast Neoplasms and Postmenopausal Disorder, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00926315, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2012.