Status:
COMPLETED
Study of Estrogen Levels in Premenopausal Women Who Have Undergone Surgery for Breast Cancer and Are Receiving Triptorelin and Tamoxifen Citrate or Exemestane on Clinical Trial IBCSG 24-02
Lead Sponsor:
ETOP IBCSG Partners Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
Up to 120 years
Phase:
NA
Brief Summary
RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn how well triptorelin given together with tamoxifen citrate or exemestane works in lowerin...
Detailed Description
OBJECTIVES: Primary * Describe estrogen levels (estradiol \[E2\], estrone \[E1\], and estrone sulphate \[E1S\]) at different time points during the first 4 years of treatment with triptorelin in com...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed resected breast cancer
- Concurrent enrollment on clinical trial IBCSG-2402 (SOFT trial) required
- Randomized to receive triptorelin in combination with either tamoxifen citrate or exemestane
- Hormone receptor status:
- Estrogen receptor- and/or progesterone receptor-positive tumor
- PATIENT CHARACTERISTICS:
- Premenopausal
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
November 25 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00975676
Start Date
November 25 2008
End Date
December 1 2016
Last Update
October 25 2021
Active Locations (24)
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1
Centre Rene Huguenin
Saint-Cloud, France
2
National Institute of Oncology
Budapest, Hungary
3
Salvatore Maugeri Foundation
Pavia, Italy
4
Clinica Oncologica, Policlinico Univeritario
Udine, Italy