Testosterone in Treating Postmenopausal Patients with Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment
Breast Cancer
Unknown Primary
18 Years and older, Female
A221102 (primary)
CDR0000730083
NCI-2012-00719
U10CA037447
CALGB-A221102
NCCTG-N10C7
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.
Eligibility
- Receiving anastrozole (1 mg) or letrozole (2.5 mg) orally once a day, for >= 21 days prior to registration and plan to continue throughout the duration of study
- Body mass index (BMI) between 18 and 35 kg/m^2
- Women who have undergone a total mastectomy or breast-conserving surgery for primary breast cancer +/- chemotherapy, +/- radiotherapy
- Must have BOTH estrogen receptor (ER) and progesterone receptor (PR)-positive tumors and BOTH must be >= 26% positive; alternatively, if ER and PR are determined by Allred score, the score needs to be 5 or higher
- Women who are postmenopausal by surgery, radiotherapy, or presence of natural amenorrhea >= 12 months
- >= 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
* Note: Patients may, or may not, be taking non-opioid analgesics
- Ability to complete questionnaire(s) by themselves or with assistance
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- 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
- Creatinine =< 1.5 x upper limit of normal (ULN) (=< 365 days prior to registration, without medical situations that should change these parameters since they were done)
- Hemoglobin > 11 g/dL (=< 365 days prior to registration, without medical situations that should change these parameters since they were done)
- White blood cell (WBC) > 3.0 (=< 365 days prior to registration, without medical situations that should change these parameters since they were done)
- Platelet count > 100,000 (=< 365 days prior to registration, without medical situations that should change these parameters since they were done)
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 1.5 x ULN (=< 365 days prior to registration, without medical situations that should change these parameters since they were done)
Treatment Sites in Georgia
**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.