Your genes may decide if breast cancer drug causes joint pain
NCT ID NCT01824836
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This study looks at whether certain genetic variations can predict which women with early-stage breast cancer will stop taking anastrozole, a common hormone therapy, because of joint and muscle pain. Researchers will follow about 1,046 postmenopausal women who are prescribed anastrozole as part of their treatment. By analyzing blood or saliva samples, they will check for specific gene variants linked to pain and inflammation. The goal is to find a genetic marker that helps doctors identify women at higher risk for these side effects, so they can offer better support or alternative treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- anastrozole (Arimidex), an aromatase inhibitor used as standard breast cancer treatment
- What this could lead to
- If certain gene variants predict who develops joint and muscle pain, doctors could tailor aromatase inhibitor therapy, reducing side effects and improving treatment adherence.
- What could go wrong
- This is an observational study, not a treatment trial, so it cannot prove cause and effect. The findings may not apply to all patients or lead to immediate clinical changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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1,046 people
The number who actually took part.
- Started
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Jun 2013
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must be post-menopausal; post-menopausal will be defined as women meeting any of the following criteria: * \>= 60 years of age; or * \< 60 years of age and amenorrheic for \>= 12 months prior to day 1 if uterus/ovaries are intact; or * \< 60 years of age, and the last menstrual period 6-12 months prior to day 1, if intact uterus/ovaries and meets biochemical criteria for menopause (follicle-stimulating hormone \[FSH\] and estradiol within institutional standard for postmenopausal status); or * \< 60 years of age, without a uterus, and meets biochemical criteria for menopause (FSH and estradiol within institutional standards for postmenopausal status); or * \< 60 years of age and history of bilateral oophorectomy; surgery must have been completed at least 4 weeks prior to day 1; or * Prior radiation castration with amenorrhea for at least 6 months * Patients must have estrogen and/or progesterone receptor positive histologically confirmed stage I-III adenocarcinoma of the breast * Patients must have completed recommended local therapy and adjuvant chemotherapy for breast cancer * Plan to treat with anastrozole for at least 12 months * Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 * Patients must be disease-free of other prior invasive malignancies for ≥ 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. Prior early stage breast cancers are also allowed as long as prior treatment did not include aromatase inhibitors. * Patients must have worst pain rated as less than 4 out of 10 on the following question: "In the past week, how much pain have you had on a scale of 0 to 10, where 0 equals no pain and 10 means the worst pain you can imagine; " NOTE: This question regarding patient's pain should be completed within one week prior to registration; this pain item may be completed orally prior to consent up to 7 days prior to registration; it is not necessary to complete this pain item via the PROMIS website * Patients must have adequate hepatic, hematologic and renal functioning to be able to be administered anastrozole at the discretion of the treating physician Exclusion Criteria: * Prior AI therapy with exemestane, letrozole, or anastrozole as adjuvant therapy or for prevention of breast cancer; prior tamoxifen as adjuvant therapy or for prevention is allowed * Patients must not be currently taking (or have taken in the past 6 months) ongoing, daily analgesic medication for active, chronic conditions (i.e., rheumatoid arthritis, carpal tunnel syndrome, tenosynovitis, systemic lupus erythematosus, gout, fibromyalgia, or severe osteoarthritis involving the hands, wrists, hips, knees, feet or ankles); (note: patients taking daily low dose aspirin are allowed to participate in this trial) * Prior history of deep vein thrombosis (DVT) or pulmonary embolism in the past 5 years
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Eastern Cooperative Oncology Group
Boston, Massachusetts, 02215, United States
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Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, 07018-1095, United States
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