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Breast NeoplasmsCYPTAMBRUT-3NCT00966043

Prevalence of Genetic Polymorphisms in Genes Coding for Tamoxifen Metabolising Enzymes

An observational study of Breast Neoplasms, run by Vlaamse Vereniging voor Obstetrie en Gynaecologie at 11 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

CYPTAM-BRUT 3 is a prospective, multicentric study in Belgium within the CYPTAM study of the Leiden University Medical Center (NTR1509) including postmenopausal women receiving tamoxifen for estrogen-receptor positive breast cancer in the adjuvant setting. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
How many people
158 participants
Where
11 sitesBelgium
Study dates
Jun 2009to Jul 2011
Phase
Observational
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Postmenopausal female breast cancer patients starting adjuvant tamoxifen therapy.

Who may be able to join

  • Female > 18 years of age
  • Written and voluntary informed consent understood signed and dated
  • Histologically or cytologically confirmed measurable invasive adenocarcinoma of the breast, amenable to curative therapy.
  • Patients must be postmenopausal as defined by criteria in appendix 1.
  • Breast cancer should be considered as oestrogen receptor positive by the clinician using immunohistochemistry readings as is standard procedure for local pathologist
  • Prior endocrine tamoxifen therapy is not allowed
Show all 11Show fewer
  • Patients are not previously treated with an endocrine agent or hormone replacement therapy needs being stopped for at least 6 months.
  • Prior chemotherapy and radiotherapy is allowed
  • Adequate renal and liver function Serum creatinine and serum bilirubin ≤ 1.5 X ULN Serum ALT and AST ≤ 2.5 X ULN (or ≤ 5 in case of liver metastases)
  • Serum calcium should be ≤ 11,6 mg/dl
  • ECOG performance status 0,1,2 (appendix 2)

Who cannot join

  • Male
  • Life threatening disease requiring a quick response (eg, extensive hepatic or pulmonary involvement)
  • Use of any endocrine treatment or recent/current use of hormone replacement therapy.
  • Contra indication for tamoxifen: history of DVT/vaginal bleeding of unknown origin
  • Dementia
  • History of other malignancy that may interfere with at least 6 months of tamoxifen therapy

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Belgium11 sites

  • Institut Bordet

    Brussels, 1000

  • UZ

    Brussels, 1090

  • UCL

    Brussels, 1200

  • AZ St-Blasius

    Dendermonde, Ookst-Vlaanderen, 9200

  • AZ St-Maarten

    Duffel, Antwerpen, 2570

  • Ziekenhuizen Oost-Limburg Camus St-Jan

    Genk, Limburg, 3600

  • Maria-Middelares

    Ghent, Oost-Vlaanderen, 9000

  • UZ

    Ghent, Oost-Vlaanderen, 9000

  • UZ

    Leuven, Vlaams-Brabant, 3000

  • Heilig-Hart Ziekenhuis

    Roeselare, West-Vlaanderen, 8800

  • AZ St-Nikolaas

    St-Niklaas, Antwerpen, 9100

Other trials in Belgium

About this study

Official title: Prevalence of Genetic Polymorphisms in Genes Coding for Tamoxifen Metabolising Enzymes, in Postmenopausal ER-positive Breast Cancer Patients According to Uterine and Biochemical Changes and Tolerability of Tamoxifen.

CYPTAM-BRUT 3 is a prospective, multicentric study in Belgium within the CYPTAM study of the Leiden University Medical Center (NTR1509) including postmenopausal women receiving tamoxifen for estrogen-receptor positive breast cancer in the adjuvant setting. The primary endpoint is the difference in uterine changes between women with a normal versus low TAS after 3 months of tamoxifen use. Secondary endpoints are serum metabolite concentrations, serum follicle-stimulating hormone level, serum sex hormone-binding globulin level and menopausal symptoms. These patients are registered in the Leiden protocol with time to breast cancer event as primary endpoint.

Read the detailed description

We will study the impact of the 'tamoxifen activity score' - based on functional genetic polymorphisms for tamoxifen metabolism and the use of drugs that interfere with tamoxifen-against tamoxifen related endpoints like uterine changes and subjective menopausal symptoms.

The prevalence of genetic polymorphisms in the CYP2D6 and other genes and differences in usage of drugs interacting with tamoxifen metabolism will be compared between women with and those without endometrial thickening on one hand and between women with and those without hot flashes on the other hand. Tamoxifen use in adjuvant setting.

  • "Tamoxifen activity score" (23): The endpoints will be correlated with a predefined 'tamoxifen activity score' which is based on the presence of single nucleotide polymorphisms (SNP) in relevant genes combined with the effect of well known drugs that interfere with the metabolism of tamoxifen. The 'tamoxifen activity score' has been associated with tamoxifen compliance by a group in the US (23). The score will be adapted to the Belgian situation based on the prevalence of these SNPs in a Belgian population of volunteers for blood donation and consecutive breast cancer patients.
  • The study setting are postmenopausal women with an early ER- positive breast cancer and not previously treated with an endocrine agent or hormone replacement therapy, with an intact uterus and clearly measurable thin endometrium/uterus. N =250
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in endometrial thickness or uterine volume

    Measured: 3-6 months

Secondary outcomes (3)

  1. Tolerability of tamoxifen-HRQoL questionnaire

    Measured: 3-6 months

  2. Vaginal bleeding

    Measured: 3-6 months

  3. Biochemical changes

    Measured: 3-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00966043
Sponsor's protocol ID
Eudract 2009-010059-28.
Other IDs
S 51521
Acronym
CYPTAMBRUT-3
Status last verified
Oct 2015
First submitted
24 Aug 2009
Last updated
28 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms, run by Vlaamse Vereniging voor Obstetrie en Gynaecologie at 11 sites in Belgium.

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 11 inclusion and 6 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: finished, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Belgium. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

change in endometrial thickness or uterine volume (time frame: 3-6 months). 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 NCT00966043.

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 28 Oct 2015.

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