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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
123
Determination of estrogen levels through gas chromatography.
Centre Rene Huguenin
Saint-Cloud, France
National Institute of Oncology
Budapest, Hungary
Salvatore Maugeri Foundation
Pavia, Italy
Clinica Oncologica, Policlinico Univeritario
Udine, Italy
INEN (Instituto de Enfermedades Neoplasicas)
Lima, Peru
Centro de Lisboa
Lisbon, Portugal
Vall d'Hebron University Hospital
Barcelona, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
Hospital Dr Negrin
Las Palmas de Gran Canaria, Spain
H.U. Arnau de Vilanova
Lleida, Spain
...and 14 more locations
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
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.
Time frame: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization
Number of Patients Who Receive Exemestane Experiencing Suboptimal Estrogen Suppression
Suboptimal estrogen suppression (SES), estradiol (E2) levels greater than 2.72 pg/mL in at least 2 post-baseline samples.
Time frame: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization
Comparison of Estrogen Levels at Different Time Points During Treatment
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
Time frame: baseline (0 months), 3, 6, 12, 18, 24, 36, and 48 months from randomization
Number of Participants With Potential Predictive Factors of Ineffective Estrogen Suppression
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
Time frame: Four years after randomization
Baseline Estrogen Levels (E2, E1, E1S) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm
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.
Time frame: Baseline
Baseline Endocrine Function Levels (FSH, LH) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm
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.
Time frame: Baseline
Endocrine Functions (FSH and LH) Status According to Treatment Assignments
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)
Time frame: Less than 12 months, at 12 months
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