Testosterone in Treating Postmenopausal Patients with Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment

Active:	No
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT01573442
Trial Phases:	Phase III	Protocol IDs:	A221102 (primary) CDR0000730083 NCI-2012-00719 U10CA037447 CALGB-A221102 NCCTG-N10C7
Eligibility:	18 Years and older, Female	Study Type:	Supportive care
Study Sponsor:	Alliance for Clinical Trials in Oncology
NCI Full Details:	http://clinicaltrials.gov/show/NCT01573442

Summary

This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia (joint pain) caused by anastrozole or letrozole. Testosterone may help relieve moderate or severe arthralgia associated with the use of aromatase inhibitors, such as anastrozole or letrozole.

Objectives

PRIMARY OBJECTIVES
I. To determine whether testosterone will reduce aromatase inhibitor (AI)-induced arthralgia and associated joint symptoms.

SECONDARY OBJECTIVES:
I. To explore whether testosterone will have an acceptable safety and tolerability profile, with particular reference to androgenic adverse events including acne, hirsutism, and alopecia.

ANCILLARY OBJECTIVES:
I. To explore whether testosterone will reduce AI-induced arthralgias and associated joint symptoms and their interference with activity.
II. To explore whether testosterone will reduce the incidence of hot flashes.
III. To explore whether testosterone will modify libido or change quality of life.
IV. To explore whether identified single nucleotide polymorphisms (SNPs), that were associated with more AI-associated arthralgias in a previous prospective trial, are more commonly seen in the patients entered into the present clinical trial, than are observed in the normal population.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive testosterone via subcutaneous (SC) implant on day 1 and then at 3 months or testosterone gel topically once daily (QD) for 6 months.

Arm II: Patients receive placebo via SC implant on day 1 and then at 3 months or topically QD for 6 months.

After completion of study treatment, patients are followed up at 3 and 6 months and monthly thereafter.

Treatment Sites in Georgia

Cancer Center at DeKalb Medical Center
2675 North Decatur Road
Suite 410
Decatur, GA 30033
404-501-7789
www.dekalbmedical.org

Doctors:

Jayanthi Srinivasiah MD

Piedmont Columbus Regional
1831 5th Ave
Columbus, GA 31901
www.columbusregional.com

Study Coordinator:

Jay Pitts, BS, CPhT
706-596-5426

Doctors:

Wilbur B. Bassett, Jr. MD

Andrew W. Pippas MD

Peter Q. Jiang MD

Suresh Nukala MD

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.