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

NCT01281137 | Completed Results DMC

• 5 other identifiers: CDR0000692740IBCSG-35-07-SUBSTUDYBIG-1-07-SUBSTUDY2007-001370-88EU-21101
• Study Type: observational
• Target: 104
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (2)

• Levels of Estrone (E1), Estradiol (E2), and Estrone Sulphate (E1S) Among Patients in the Longitudinal Analysis Population

  In SOLE-EST, levels of E1, E2, and E1S were summarized over time at 0 (baseline), 9, 10.5, and 12 months from randomization among patients in the longitudinal analysis population (N=90 with post-baseline sample).

  0 (baseline), 9, 10.5, and 12 months from randomization

• Percent Change of E1, E2, and E1S Levels at 9, 10.5, and 12 Months From Baseline, by Treatment Group

  Changes in hormone levels (E1, E2, and E1S levels), as percentage change over time according to treatment assignment (at 9, 10.5 and 12 months from baseline).

  9, 10.5, and 12 months from baseline

Secondary Outcomes (3)

• Toxicity Grade Changes for Arthralgia, Hot Flushes, and Insomnia

  6 and 12 months

• Quality of Life (QoL) Score Changes

  6 and 12 months: Change is calculated from 12 months minus 6 months, therefore positive values indicate an improved condition and negative values indicate a declined condition

• Change in Grip-strength Score in the Dominant Hand

  Changes in grip strength score is calculated at 12 months minus 9 months

Interventions

polymorphism analysis GENETIC

SNPs will be genotyped in whole blood samples taken at baseline.

laboratory biomarker analysis OTHER

Biomarkers will be assessed in blood and serum samples at different time points.

quality-of-life assessment PROCEDURE

Quality of life will be assessed using the Breast Cancer Prevention Trial (BCPT) Symptom Scales and the IBCSG Trial 35-07 QL Form.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients randomized to the SOLE trial (IBCSG 35-07) and participate in the Quality of Life substudy.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ETOP IBCSG Partners Foundation: lead

Study Sites (2)

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

CHU Liege - Domaine Universitaire du Sart Tilman

Liège, B-4000, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, whole blood,

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DNA Fingerprinting; Genetic Techniques; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Limitations and Caveats

After 5 years of adjuvant endocrine therapy, resistant tumoral cells could be different from those present at initial diagnosis, and the apoptotic effect of estrogen on these cells might be insufficient. It is possible that the intermittent treatment was given too late.

Results Point of Contact

• Title: Head Trial Activities and Deputy Director: Dr. Heidi Roschitzki-Voser
• Organization: International Breast Cancer Study Group (IBCSG)

heidi.roschitzki@ibcsg.org

+41 31 511 94 00

Study Officials

• Jacquie Chirgwin, MD

  Box Hill Hospital

  STUDY CHAIR

• Guy Jerusalem, MD, PhD

  CHU Liege - Domaine Universitaire du Sart Tilman

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 21, 2011
• Study Start: January 1, 2011
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: October 6, 2021
• Results First Posted: October 6, 2021

Record last verified: 2021-09

Locations

AU (1); BE (1)