Study of Changes in Estrogen Levels and Grip Strength in Postmenopausal Women Who Have Received 4 to 6 Years of Hormone Therapy for Breast Cancer and Are Currently Receiving Letrozole on Clinical Trial IBCSG-35-07
Ключови думи
Резюме
Описание
OBJECTIVES:
Primary
- To determine the serum level of estrogens (Estradiol [E2], Estrone [E1], and Estrone Sulphate [E1S] and sex hormone binding globulin [SHBG]) in postmenopausal women with prior endocrine-responsive, node-positive, resectable breast cancer completing 4 to 6 years of adjuvant endocrine therapy and enrolled on clinical trial IBCSG-35-07 receiving letrozole.
- To determine the degree of recovery of E2, E1, and E1S during the 3-month letrozole-off gap.
Secondary
- To determine the association between estrogen level changes and the clinical outcomes of toxicity and quality of life.
- To determine the effect of prior adjuvant endocrine therapy, age, body mass index, and type of menopause on estrogen levels.
- To determine the variability of estrogen level changes and its association with germline single nucleotide polymorphisms.
- To examine changes in grip-strength score.
OUTLINE: This is a multicenter study.
All patients undergo blood sample collection at baseline for the analysis of single nucleotide polymorphisms, after randomization on clinical trial IBCSG-35-07 and prior to the beginning treatment on IBCSG-35-07. Patients also undergo serum collection at baseline and at 9, 10.5, and 12 months for the analysis of estrogen levels and sex hormone binding globulins. Patients undergo measurement of grip strength at baseline and at 9 and 12 months. Samples may be banked for future research studies.
Patients complete quality-of-life questionnaires (Breast Cancer Prevention Trial [BCPT] Symptom Scales on Form 35-PRS and IBCSG Trial 35-07 QL Form) periodically.
Дати
| Последна проверка: | 02/28/2019 |
| Първо изпратено: | 01/19/2011 |
| Очаквано записване подадено: | 01/19/2011 |
| Първо публикувано: | 01/20/2011 |
| Изпратена последна актуализация: | 03/14/2019 |
| Последна актуализация публикувана: | 03/18/2019 |
| Действителна начална дата на проучването: | 12/31/2010 |
| Приблизителна дата на първично завършване: | 03/31/2020 |
| Очаквана дата на завършване на проучването: | 03/31/2020 |
Състояние или заболяване
Интервенция / лечение
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment
Фаза
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Female |
| Метод за вземане на проби | Non-Probability Sample |
| Приема здрави доброволци | Да |
| Критерии | DISEASE CHARACTERISTICS: - Previously diagnosed with breast cancer - Endocrine-responsive, node-positive, resectable disease - Disease-free following 4-6 years of prior adjuvant endocrine therapy with selective estrogen-receptor modulators and/or aromatase inhibitors - Patient must be currently enrolled on clinical trial IBCSG-35-07 as well as the Quality-of-Life substudy - Hormone receptor status not specified PATIENT CHARACTERISTICS: - Postmenopausal PRIOR CONCURRENT THERAPY: - See Disease Characteristics |
Резултат
Първични изходни мерки
1. Levels of Estradiol (E2), Estrone (E1), and Estrone Sulphate (E1S) at 0, 9, 10.5, and 12 months from randomization on clinical trial IBCSG-35-07 [12 months after randomization of last patient]
2. Percent change (suppression or recovery) of E2, E1, and E1S at baseline and at 9, 10.5, and 12 months from randomization on clinical trial IBCSG-35-07 [12 months after randomization of last patient]
Вторични изходни мерки
1. Toxicity grade changes (for arthralgia, hot flushes, and insomnia) between 6 months (on letrozole) and 12 months (off letrozole for 3 months) and its correlation with the percent of recovery of estrogen levels [12 months after randomization of last patient]
2. Quality of life score change between 6 months (on letrozole) and 12 months (off letrozole for 3 months) and its correlation with the percent of recovery of estrogen levels [12 months after randomization of last patient]
3. Changes in grip-strength score at 9 months and 12 months [12 months after randomization of last patient]
