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:
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT01281137
First received: January 20, 2011
Last updated: November 1, 2013
Last verified: November 2013
  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:
    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.
Detailed Description:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 1, 2013
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 September 18, 2014