Español
Questions About Cancer? 1-800-4-CANCER
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, Supportive care, TreatmentActive18 and overNCI, OtherA221102
CDR0000730083, NCI-2012-00719, U10CA037447, CALGB-A221102, NCCTG-N10C7, NCT01573442

Trial Description

Summary

RATIONALE: Testosterone may help relieve moderate or severe arthralgia associated with the use of aromatase inhibitors, such as anastrozole or letrozole.

PURPOSE: This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia caused by anastrozole or letrozole.

Further Study Information

OUTLINE:

This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. Patients receive testosterone transdermally on day 1 and then at 3 months on Arm I. Patients receive placebo transdermally on day 1 and then at 3 months on Arm II. The primary objective of the study is to determine whether testosterone will reduce aromatase inhibitor (AI)-induced arthralgia and associated joint symptoms. The secondary objective of the study is to explore whether testosterone will have an acceptable safety and tolerability profile, with particular reference to androgenic adverse events including acne, hirsutism, and alopecia. After completion of study treatment, patients are followed up for 6 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Women who have undergone a total mastectomy or breast-conserving surgery for primary breast cancer +/-chemotherapy and +/-radiotherapy
  • Receiving anastrozole (1 mg) or letrozole (2.5 mg) orally once a day, for ≥ 21 days prior to registration
  • Must have BOTH estrogen receptor-positive (ER+) and progesterone receptor-positive (PR+) tumors and BOTH must be ≥ 30% positive
  • ≥ 5/10 arthralgia (in hands, wrist, knees, or hips) while being treated with anastrozole or letrozole which is felt by the patient to be caused by their aromatase inhibitor, as measured by verbally addressing the following question: "Please rate your pain by picking a number, from 0 to 10 (0 being none and 10 being as bad as you can imagine) that best describes your pain from your aromatase inhibitor breast cancer medication on AVERAGE, over the past week."
  • No presence of residual or recurrent cancer (locally or metastatic)

PATIENT CHARACTERISTICS:

  • Body Mass Index (BMI) between 18 and 32 kg/m²
  • Women who are postmenopausal by surgery, radiotherapy, or presence of natural amenorrhea ≥ 12 months
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) ≤ 1.5 times upper limit of normal (ULN)
  • ECOG Performance Status (PS) 0, 1, or 2
  • Serum creatinine ≤1.5 times ULN
  • Hemoglobin > 11 g/dL
  • White blood cell (WBC) > 3,000/mm³
  • Platelets > 100,000/mm³
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Willing to provide informed written consent
  • Willing to return to an Alliance enrolling institution for follow-up
  • Willing to provide blood samples for correlative research purposes
  • No diabetes mellitus or glucose intolerance, defined as a fasting glucose > 125 mg/dL
  • No history of coronary artery disease (angina or myocardial infarction)
  • No known hypersensitivity to any component of testosterone
  • No history of a deep venous thrombosis or a thromboembolism

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No patients on hormone-replacement therapy (HRT) ≤ 4 weeks before prior to registration
  • No prolonged systemic corticosteroid treatment, except for topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airway diseases), eye drops, or local injections (e.g., intra-articular)
  • Short duration (< 2 weeks) of systemic corticosteroids is allowed (e.g., for chronic obstructive pulmonary disease), but not within 30 days prior to registration
  • Not receiving any other investigational agent
  • No concurrent use of the aromatase inhibitor exemestane
  • No concurrent radiation therapy or chemotherapy
  • No current or planned use of cyclosporine, anticoagulants, oxyphenbutazone, insulin, oral or injectable vitamin D doses over 4,000 IU/day or tamoxifen

Trial Contact Information

Trial Lead Organizations/Sponsors

Alliance for Clinical Trials in Oncology

National Cancer Institute

Charles L. LoprinziPrincipal Investigator

Trial Sites

U.S.A.
Illinois
  La Grange
 La Grange Memorial Hospital
 James E. Hannigan Ph: 800-323-8622
Maryland
  Rockville
 Unidentified Site
 Charles L. Loprinzi Ph: 507-284-4849
  Email: loprinzi@mayo.edu
Wisconsin
  Milwaukee
 Oncology Alliance, SC - Milwaukee - South
 Rubina Qamar Ph: 888-709-2080

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01573442
ClinicalTrials.gov processed this data on November 12, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

Back to TopBack to Top