NCT00966043

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2009

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

2.1 years

First QC Date

August 24, 2009

Last Update Submit

October 27, 2015

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • change in endometrial thickness or uterine volume

    3-6 months

Secondary Outcomes (3)

  • Tolerability of tamoxifen-HRQoL questionnaire

    3-6 months

  • Vaginal bleeding

    3-6 months

  • Biochemical changes

    3-6 months

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postmenopausal female breast cancer patients starting adjuvant tamoxifen therapy.

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

AZ St-Maarten

Duffel, Antwerpen, 2570, Belgium

Location

AZ St-Nikolaas

St-Niklaas, Antwerpen, 9100, Belgium

Location

Ziekenhuizen Oost-Limburg Camus St-Jan

Genk, Limburg, 3600, Belgium

Location

AZ St-Blasius

Dendermonde, Ookst-Vlaanderen, 9200, Belgium

Location

Maria-Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Heilig-Hart Ziekenhuis

Roeselare, West-Vlaanderen, 8800, Belgium

Location

Institut Bordet

Brussels, 1000, Belgium

Location

UZ

Brussels, 1090, Belgium

Location

UCL

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Patrick Neven

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 26, 2009

Study Start

June 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 28, 2015

Record last verified: 2015-10

Locations

BE(11)