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
- Conditions
- Breast Cancer
- Interventions
- Other: gas chromatography / tandem mass spectometry
- Registration Number
- NCT00975676
- Lead Sponsor
- ETOP IBCSG Partners Foundation
- 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 lowering estrogen levels.
PURPOSE: This clinical trial is studying 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-2402.
- 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 combination with either tamoxifen citrate or exemestane on clinical trial IBCSG-2402 in premenopausal women with resected breast cancer.
* Assess whether there is a suboptimally estrogen-suppressed subgroup of patients who receive exemestane.
Secondary
* Compare estrogen levels (E2, E1, E1S) at different time points during treatment with triptorelin in combination with either tamoxifen citrate or exemestane.
* Examine potential predictive factors of ineffective estrogen suppression (e.g., age, chemotherapy \[yes/no\], type of chemotherapy received, smoking history, BMI, and evidence of menses at study entry).
* Investigate the predictive value of optimal estrogen suppression during the first 6 and 12 months of treatment with regard to long-term estrogen suppression (4-year period).
* Compare disease-free survival of suboptimally estrogen-suppressed patients treated with exemestane with that of patients with optimal suppression (exploratory analysis).
* Examine related endocrine function (FSH and LH) to further elucidate causes of suboptimal estrogen suppression.
OUTLINE: This is a multicenter study.
Blood samples are collected at baseline and at 3, 6, 12, 18, 24, 36, and 48 months for measurement of estrogen levels (estradiol \[E2\], estrone \[E1\], and estrone sulphate \[E1S\]) by gas chromatography-mass spectrometry and measurement of endocrine function (FSH and LH).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 123
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Triptorelin plus exemestane gas chromatography / tandem mass spectometry Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years. Triptorelin plus tamoxifen gas chromatography / tandem mass spectometry Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.
- Primary Outcome Measures
Name Time Method Number of Patients Who Receive Exemestane Experiencing Suboptimal Estrogen Suppression 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization Suboptimal estrogen suppression (SES), estradiol (E2) levels greater than 2.72 pg/mL in at least 2 post-baseline samples.
Estrogen Levels (Estradiol [E2], Estrone [E1], and Estrone Sulphate [E1S]) at Different Time Points During the First 4 Years of Treatment With Triptorelin (Trip) in Combination With Either Tamoxifen (T) or Exemestane (E), IBCSG 24-02 SOFT-EST Substudy 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization Estrogen levels (estradiol \[E2\], estrone \[E1\], and estrone sulphate \[E1S\]) were measured at the following time points for the SOFT-EST: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization. Some of these samples were not used, including un-scheduled sample, post surgery or vaginal bleeding, samples taken post early discontinuation (ED) or discontinuation of GnRH injections.
- Secondary Outcome Measures
Name Time Method Comparison of Estrogen Levels at Different Time Points During Treatment baseline (0 months), 3, 6, 12, 18, 24, 36, and 48 months from randomization Percent (%) change of estrogen levels estradiol (E2), estrone (E1), and estrone sulphate (E1S) at each timepoint from baseline: e.g. {E2(t)-E2(0)} / E2(0)\*100, where t= 3, 6, 12, 18, 24, 36, and 48 months from randomization
Number of Participants With Potential Predictive Factors of Ineffective Estrogen Suppression Four years after randomization Potential predictive factors of ineffective estrogen suppression (SES) (with E2 \> 2.72 pg/mL, or any vaginal bleeding \> 3 months after triptorelin start or pregnancy) such as: age, evidence of menses at entry, BMI, chemotherapy (yes/no), and, type of chemotherapy received
Baseline Estrogen Levels (E2, E1, E1S) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm Baseline The secondary analysis explored baseline estrogen levels (E2, E1, E1S) with suboptimal estrogen suppression (SES) where estrogen (E2) \> 2.72 pg/mL in the exemestane + triptorelin arm.
Baseline Endocrine Function Levels (FSH, LH) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm Baseline The secondary analysis explored endocrine functions (FSH, LH) with suboptimal estrogen suppression (SES) where estrogen (E2) \> 2.72 pg/mL in the exemestane + triptorelin arm.
Endocrine Functions (FSH and LH) Status According to Treatment Assignments Less than 12 months, at 12 months Endocrine function (FSH, LH) status according to treatment assignments at 12 months using 12 month data alone or 12 month data plus earlier data (when 12 month not available)
Trial Locations
- Locations (24)
Centre Rene Huguenin
🇫🇷Saint-Cloud, France
Vall d'Hebron University Hospital
🇪🇸Barcelona, Spain
Centro de Lisboa
🇵🇹Lisboa, Portugal
Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital Dr Negrin
🇪🇸Las Palmas de Gran Canaria, Spain
Centro Oncologico Md Anderson
🇪🇸Madrid, Spain
Hospital Ramon Y Cajal
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Son Dureta
🇪🇸Palma, Spain
Hospital Sant Joan de Reus
🇪🇸Reus, Spain
Hospital Sant Pau i Santa Tecla
🇪🇸Tarragona, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Instituto Valenciano de Oncologia
🇪🇸Valencia, Spain
Sahlgrenska University Hospital Gothenburg
🇸🇪Göteborg, Sweden
Kantonsspital Graubünden
🇨ðŸ‡Chur, Switzerland
Spital Thun
🇨ðŸ‡Thun, Switzerland
Multidisciplinary Oncology Centre, CHUV
🇨ðŸ‡Lausanne, Switzerland
INEN (Instituto de Enfermedades Neoplasicas)
🇵🇪Lima, Peru
National Institute of Oncology
ðŸ‡ðŸ‡ºBudapest, Hungary
Salvatore Maugeri Foundation
🇮🇹Pavia, Italy
Clinica Oncologica, Policlinico Univeritario
🇮🇹Udine, Italy
H.U. Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital Son Llatzer
🇪🇸Palma, Spain
Brust-Zentrum
🇨ðŸ‡Zürich, Switzerland