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 (SOLE-EST)
This study is ongoing, but not recruiting participants.
Sponsor:
International Breast Cancer Study Group
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT01281137
First received: January 20, 2011
Last updated: July 20, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Studying samples of blood in the laboratory from patients receiving treatment for cancer may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This clinical trial is studying 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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Genetic: polymorphism analysis Other: laboratory biomarker analysis Procedure: quality-of-life assessment |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | SOLE Estrogen Substudy (SOLE-EST) - Investigating Changes in Estrogen Levels and Grip Strength for Patients Participating in the SOLE Trial |
Resource links provided by NLM:
Further study details as provided by International Breast Cancer Study Group:
Primary Outcome Measures:
- 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 [ Time Frame: 12 months after randomization of last patient ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 12 months after randomization of last patient ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 [ Time Frame: 12 months after randomization of last patient ] [ Designated as safety issue: Yes ]
- 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 [ Time Frame: 12 months after randomization of last patient ] [ Designated as safety issue: No ]
- Changes in grip-strength score at 9 months and 12 months [ Time Frame: 12 months after randomization of last patient ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Serum, whole blood,
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2020 |
| Estimated Primary Completion Date: | December 2020 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Genetic: polymorphism analysis
SNPs will be genotyped in whole blood samples taken at baseline.
Other: laboratory biomarker analysis
Biomarkers will be assessed in blood and serum samples at different time points.
Procedure: quality-of-life assessment
Quality of life will be assessed using the Breast Cancer Prevention Trial (BCPT) Symptom Scales and the IBCSG Trial 35-07 QL Form.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients randomized to the SOLE trial (IBCSG 35-07) and participate in the Quality of Life substudy.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281137
Locations
| Australia, Victoria | |
| Box Hill Hospital | |
| Box Hill, Victoria, Australia, 3128 | |
| Belgium | |
| CHU Liege - Domaine Universitaire du Sart Tilman | |
| Liege, Belgium, B-4000 | |
Sponsors and Collaborators
International Breast Cancer Study Group
Investigators
| Study Chair: | Jacquie Chirgwin, MD | Box Hill Hospital |
| Study Chair: | Guy Jerusalem, MD, PhD | CHU Liege - Domaine Universitaire du Sart Tilman |
More Information
Additional Information:
No publications provided
| Responsible Party: | International Breast Cancer Study Group |
| ClinicalTrials.gov Identifier: | NCT01281137 History of Changes |
| Other Study ID Numbers: | CDR0000692740, IBCSG-35-07-SUBSTUDY, BIG-1-07-SUBSTUDY, 2007-001370-88, EU-21101 |
| Study First Received: | January 20, 2011 |
| Last Updated: | July 20, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products Italy: The Italian Medicines Agency Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by International Breast Cancer Study Group:
|
stage IA breast cancer stage IB breast cancer stage II breast cancer stage IIIA breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013