Estrogen Receptor-positive Breast CancerNCT01824836
A Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)
A study testing anastrozole in people with Estrogen Receptor-positive Breast Cancer and Musculoskeletal Complications, run by ECOG-ACRIN Cancer Research Group at 2 sites in United States.
Trial summary
E1Z11 is a study to determine whether certain genetic information can predict which breast cancer patients will discontinue treatment with aromatase inhibitors (AIs) due to the development of musculoskeletal symptoms (MSS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Estrogen Receptor-positive Breast Cancer, Musculoskeletal Complications, Progesterone Receptor-positive Breast Cancer
- What is being tested?
- anastrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,046 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jun 2013to Dec 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eastern Cooperative Oncology Group
Boston, Massachusetts, 02215
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, 07018-1095
About this study
Official title: A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)
E1Z11 is a study to determine whether certain genetic information can predict which breast cancer patients will discontinue treatment with aromatase inhibitors (AIs) due to the development of musculoskeletal symptoms (MSS). Women with stage I-III breast cancer who are prescribed the aromatase inhibitor anastrozole as treatment may join.
Read the detailed description
PRIMARY OBJECTIVES:
- To validate previously identified associations between 10 specific single nucleotide polymorphisms (single nucleotide polymorphisms [SNPs]) and discontinuation of treatment with aromatase inhibitors (AIs) due to the development of musculoskeletal symptoms (MSS) among women with breast cancer.
SECONDARY OBJECTIVES:
- To determine whether other SNPs in cytochrome P450 enzymes (CYP), glucuronosyltransferases (UGT), Vitamin D, serotonin and other receptors are associated with discontinuation of treatment due to the development of severe aromatase inhibitor-associated musculoskeletal symptoms (AIMSS).
II. To determine whether other SNPs in CYP, UGT, Vitamin D, serotonin and other receptors are associated with the development of other potential complications of AI therapy.
III. To develop a gene signature that can identify patients at risk for developing severe anastrozole-related AIMSS and other potential complications of AI therapy.
IV. To determine the epidemiology and predictors of severe AIMSS and of AI discontinuation.
- To describe patient reported outcomes for minority patients with breast cancer treated with AIs.
VI. To assess the utility of the Patient Reported Outcomes Management Information System (PROMIS) system to collect patient reported outcomes in a cooperative group study, and validate the PROMIS Physical Function 20a form in patients with AIMSS.
VII. To develop a model that incorporates patient ratings of treatment burden, fear of recurrence and adherence behaviors to describe patient decisions to continue or discontinue anastrozole.
VIII. To collect serum samples for future testing for biomarkers of AIMSS.
OUTLINE:
Patients receive anastrozole orally (PO) once daily (QD) for 12 months.
After the completion of study treatment, patients are followed up for 12 months.
- Conditions
- Estrogen Receptor-positive Breast Cancer, Musculoskeletal Complications, Progesterone Receptor-positive Breast Cancer, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer
- Being tested
- anastrozole
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anastrozoleDrug
Also called Arimidex
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (anastrozole) | Experimental | Patients receive anastrozole PO QD for 12 months. Receives: Drug: anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Associations Between Pre-specified Single Nucleotide Polymorphisms (SNPs) and Discontinuation of Treatment With Aromatase Inhibitor (AI) Due to the Development of Musculoskeletal Symptoms (MSS)
Patients were classified into two groups based on whether or not they discontinued treatment due to MSS within 12 months. The 10 SNPs evaluated include ESR1 (rs2234693, rs2347868, rs9340835), CYP19A1 (rs1062033, rs4646), TCL1A (rs11849538, rs2369049, rs7158782, rs7159713), and HTR2A (rs2296972).
The associations between SNPs and discontinuation of treatment due to AIMSS are presented by odds ratios (ORs). An OR of 1 suggests no association, while an OR > 1 indicates a greater chance of treatment discontinuation in the one group compared to the reference group, and an OR < 1 suggests a lower chance.
Measured: Assessed at baseline and 3, 6, 9, 12 months
Secondary outcomes (10)
Associations Between Other SNPs in CYP, UGT, Vitamin D, Serotonin and Other Receptors and Discontinuation of Treatment Due to the Development of Severe AIMSS
The associations between discontinuation of treatment due to AIMSS and various factors, including other SNPs in CYP, UGT, vitamin D, serotonin and other receptors are evaluated.
Measured: Assessed at baseline and 3, 6, 9, 12 months
Associations Between Development of Other Potential Complications of AI Therapy and Other SNPs in CYP, UGT, Vitamin D, Serotonin and Other Receptors
The associations between development of other potential complications of AI therapy and other SNPs in CYP, UGT, vitamin D, serotonin and other receptors are evaluated.
Measured: Assessed at baseline, and 3, 6, 9, 12 months
The Distribution of the Development of AIMSS by Genotype of the rs2296972 SNP
The association between the rs2296972 SNP in the HTR2A-AS1;HTR2A gene and the development of AIMSS was evaluated. Patients were categorized into CC, AC and AA genotypes for the rs2296972 SNP.
AIMSS was defined using two criteria, physician assessment and the Stanford Health Assessment Questionnaire (HAQ) score. Patients who developed joint pain or stiffness were encouraged not to discontinue treatment and were to be seen by their treating clinician within 2 weeks of the symptom(s). At the time of the visit, the treating clinician could make an AIMSS diagnosis based on a clinical assessment. AIMSS based on HAQ was defined as ≥0.20 mean increase in scaled HAQ score at 3, 6, 9 or 12 months from baseline.
Measured: Assessed at baseline, and 3, 6, 9, 12 months
The Distribution of Development of AIMSS by Race
The association between race and the development of AIMSS was evaluated. AIMSS was defined using two criteria, physician assessment and the Stanford Health Assessment Questionnaire (HAQ) score. Patients who developed joint pain or stiffness were encouraged not to discontinue treatment and were to be seen by their treating clinician within 2 weeks of the symptom(s). At the time of the visit, the treating clinician could make an AIMSS diagnosis based on a clinical assessment. AIMSS based on HAQ was defined as ≥0.20 mean increase in scaled HAQ score at 3, 6, 9 or 12 months from baseline.
Measured: Assessed at baseline, and 3, 6, 9, 12 months
Patient Reported Outcomes (Health Assessment Questionnaire [HAQ] Pain Scores) at Baseline for Patients With Breast Cancer Treated With Aromatase Inhibitors (AIs).
HAQ was administered to evaluate pain among the patients. The pain scores range between 0 and 3 with 0 indicating no pain and 3 indicating very severe pain.
Measured: Assessed at baseline
Patient Reported Outcomes (Health Assessment Questionnaire [HAQ] Pain Scores) at 3 Months for Patients With Breast Cancer Treated With Aromatase Inhibitors (AIs).
HAQ was administered to evaluate pain among the patients. The pain scores range between 0 and 3 with 0 indicating no pain and 3 indicating very severe pain.
Measured: Assessed at 3 months
Patient Reported Outcomes (Health Assessment Questionnaire [HAQ] Pain Scores) at 6 Months for Patients With Breast Cancer Treated With Aromatase Inhibitors (AIs).
HAQ was administered to evaluate pain among the patients. The pain scores range between 0 and 3 with 0 indicating no pain and 3 indicating very severe pain.
Measured: Assessed at 6 months
Patient Reported Outcomes (Health Assessment Questionnaire [HAQ] Pain Scores) at 9 Months for Patients With Breast Cancer Treated With Aromatase Inhibitors (AIs).
HAQ was administered to evaluate pain among the patients. The pain scores range between 0 and 3 with 0 indicating no pain and 3 indicating very severe pain.
Measured: Assessed at 9 months
Patient Reported Outcomes (Health Assessment Questionnaire [HAQ] Pain Scores) at 12 Months for Patients With Breast Cancer Treated With Aromatase Inhibitors (AIs).
HAQ was administered to evaluate pain among the patients. The pain scores range between 0 and 3 with 0 indicating no pain and 3 indicating very severe pain.
Measured: Assessed at 12 months
To Develop a Model That Incorporates Patient Ratings of Treatment Burden, Fear of Recurrence and Adherence Behaviors to Describe Patient Decisions to Continue or Discontinue Anastrozole
To develop a model that incorporates patient ratings of treatment burden, fear of recurrence and adherence behaviors to describe patient decisions to continue or discontinue anastrozole
Measured: Assessed at baseline, diagnosis of AIMSS, discontinuation of treatment due to AIMSS, one month after treatment discontinuation due to AIMSS, and 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study start11 Jun 2013
- Primary completion9 Jun 2022
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Estrogen Receptor-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,046 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vered Stearns, Principal investigator, Eastern Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824836
- Sponsor's protocol ID
- E1Z11
- Other IDs
- NCI-2013-00426, U10CA037403
- Status last verified
- Aug 2026
- First submitted
- 2 Apr 2013
- Last updated
- 27 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
Publications
Stearns V, Jegede OA, Chang VT, Skaar TC, Berenberg JL, Nand R, Shafqat A, Jacobs NL, Luginbuhl W, Gilman P, Benson AB 3rd, Goodman JR, Buchschacher GL Jr, Henry NL, Loprinzi CL, Flynn PJ, Mitchell EP, Fisch MJ, Sparano JA, Wagner LI. A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms: Results from ECOG-ACRIN E1Z11. Clin Cancer Res. 2024 Jul 1;30(13):2709-2718. doi: 10.1158/1078-0432.CCR-23-2137.
PubMed 38640040
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)
- ClinicalTrials.gov ID
- NCT01824836
- Acronym / sponsor ID
- E1Z11
- Conditions
- Estrogen Receptor-positive Breast Cancer, Musculoskeletal Complications, Progesterone Receptor-positive Breast Cancer, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,046 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Jun 2013 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Posted 24 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
E1Z11 is a study to determine whether certain genetic information can predict which breast cancer patients will discontinue treatment with aromatase inhibitors (AIs) due to the development of musculoskeletal symptoms (MSS). Women with stage I-III breast cancer who are prescribed the aromatase inhibitor anastrozole as treatment may join.
Detailed description
PRIMARY OBJECTIVES:
- To validate previously identified associations between 10 specific single nucleotide polymorphisms (single nucleotide polymorphisms [SNPs]) and discontinuation of treatment with aromatase inhibitors (AIs) due to the development of musculoskeletal symptoms (MSS) among women with breast cancer.
SECONDARY OBJECTIVES:
- To determine whether other SNPs in cytochrome P450 enzymes (CYP), glucuronosyltransferases (UGT), Vitamin D, serotonin and other receptors are associated with discontinuation of treatment due to the development of severe aromatase inhibitor-associated musculoskeletal symptoms (AIMSS).
II. To determine whether other SNPs in CYP, UGT, Vitamin D, serotonin and other receptors are associated with the development of other potential complications of AI therapy.
III. To develop a gene signature that can identify patients at risk for developing severe anastrozole-related AIMSS and other potential complications of AI therapy.
IV. To determine the epidemiology and predictors of severe AIMSS and of AI discontinuation.
- To describe patient reported outcomes for minority patients with breast cancer treated with AIs.
VI. To assess the utility of the Patient Reported Outcomes Management Information System (PROMIS) system to collect patient reported outcomes in a cooperative group study, and validate the PROMIS Physical Function 20a form in patients with AIMSS.
VII. To develop a model that incorporates patient ratings of treatment burden, fear of recurrence and adherence behaviors to describe patient decisions to continue or discontinue anastrozole.
VIII. To collect serum samples for future testing for biomarkers of AIMSS.
OUTLINE:
Patients receive anastrozole orally (PO) once daily (QD) for 12 months.
After the completion of study treatment, patients are followed up for 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (anastrozole) | Experimental | Drug: anastrozolePatients receive anastrozole PO QD for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must be post-menopausal; post-menopausal will be defined as women meeting any of the following criteria:
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anastrozoleAlso: ArimidexGiven PO | Drug | Supportive care (anastrozole) |
Primary outcome
Associations Between Pre-specified Single Nucleotide Polymorphisms (SNPs) and Discontinuation of Treatment With Aromatase Inhibitor (AI) Due to the Development of Musculoskeletal Symptoms (MSS)
Time frame: Assessed at baseline and 3, 6, 9, 12 months
Patients were classified into two groups based on whether or not they discontinued treatment due to MSS within 12 months. The 10 SNPs evaluated include ESR1 (rs2234693, rs2347868, rs9340835), CYP19A1 (rs1062033, rs4646), TCL1A (rs11849538, rs2369049, rs7158782, rs7159713), and HTR2A (rs2296972). The associations between SNPs and discontinuation of treatment due to AIMSS are presented by odds ratios (ORs). An OR of 1 suggests no association, while an OR > 1 indicates a greater chance of treatment discontinuation in the one group compared to the reference group, and an OR < 1 suggests a lower chance.
10 secondary outcomes
Associations Between Other SNPs in CYP, UGT, Vitamin D, Serotonin and Other Receptors and Discontinuation of Treatment Due to the Development of Severe AIMSS
Time frame: Assessed at baseline and 3, 6, 9, 12 months
Associations Between Development of Other Potential Complications of AI Therapy and Other SNPs in CYP, UGT, Vitamin D, Serotonin and Other Receptors
Time frame: Assessed at baseline, and 3, 6, 9, 12 months
The Distribution of the Development of AIMSS by Genotype of the rs2296972 SNP
Time frame: Assessed at baseline, and 3, 6, 9, 12 months
The Distribution of Development of AIMSS by Race
Time frame: Assessed at baseline, and 3, 6, 9, 12 months
Patient Reported Outcomes (Health Assessment Questionnaire [HAQ] Pain Scores) at Baseline for Patients With Breast Cancer Treated With Aromatase Inhibitors (AIs).
Time frame: Assessed at baseline
Patient Reported Outcomes (Health Assessment Questionnaire [HAQ] Pain Scores) at 3 Months for Patients With Breast Cancer Treated With Aromatase Inhibitors (AIs).
Time frame: Assessed at 3 months
Patient Reported Outcomes (Health Assessment Questionnaire [HAQ] Pain Scores) at 6 Months for Patients With Breast Cancer Treated With Aromatase Inhibitors (AIs).
Time frame: Assessed at 6 months
Patient Reported Outcomes (Health Assessment Questionnaire [HAQ] Pain Scores) at 9 Months for Patients With Breast Cancer Treated With Aromatase Inhibitors (AIs).
Time frame: Assessed at 9 months
Patient Reported Outcomes (Health Assessment Questionnaire [HAQ] Pain Scores) at 12 Months for Patients With Breast Cancer Treated With Aromatase Inhibitors (AIs).
Time frame: Assessed at 12 months
To Develop a Model That Incorporates Patient Ratings of Treatment Burden, Fear of Recurrence and Adherence Behaviors to Describe Patient Decisions to Continue or Discontinue Anastrozole
Time frame: Assessed at baseline, diagnosis of AIMSS, discontinuation of treatment due to AIMSS, one month after treatment discontinuation due to AIMSS, and 3, 6, 9, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38640040Stearns V, Jegede OA, Chang VT, Skaar TC, Berenberg JL, Nand R, Shafqat A, Jacobs NL, Luginbuhl W, Gilman P, Benson AB 3rd, Goodman JR, Buchschacher GL Jr, Henry NL, Loprinzi CL, Flynn PJ, Mitchell EP, Fisch MJ, Sparano JA, Wagner LI. A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms: Results from ECOG-ACRIN E1Z11. Clin Cancer Res. 2024 Jul 1;30(13):2709-2718. doi: 10.1158/1078-0432.CCR-23-2137.
- Individual participant dataSharing planned: Yes. Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vered Stearns principal investigator
Eastern Cooperative Oncology Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anastrozole in people with Estrogen Receptor-positive Breast Cancer and Musculoskeletal Complications, run by ECOG-ACRIN Cancer Research Group at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Associations Between Pre-specified Single Nucleotide Polymorphisms (SNPs) and Discontinuation of Treatment With Aromatase Inhibitor (AI) Due to the Development of Musculoskeletal Symptoms (MSS) (time frame: Assessed at baseline and 3, 6, 9, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01824836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.