Stage IIIA Breast Cancer Clinical Trial
Official title:
A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)
Verified date | November 2023 |
Source | Eastern Cooperative Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
E1Z11 is a study to determine whether certain genetic information can predict which breast cancer patients will discontinue treatment with AIs due to the development of musculoskeletal symptoms (MSS). Women with stage 1-111 breast cancer who are prescribed the aromatase inhibitor anastrozole as treatment may join.
Status | Active, not recruiting |
Enrollment | 1046 |
Est. completion date | January 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 - Patients must not have received 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 - Plan to treat with anastrozole for at least 12 months - Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 - 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) - Patients must not have a prior history of deep vein thrombosis (DVT) or pulmonary embolism in the past 5 years - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Eastern Cooperative Oncology Group | Boston | Massachusetts |
United States | Veterans Adminstration New Jersey Health Care System | East Orange | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Eastern Cooperative Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Discontinuation of treatment following development of AIMSS determined by scores on the Health Assessment Questionnaire (HAQ) instrument | Logistic regression will be used to test the association between having a minor allele and the log odds of discontinuation of treatment, adjusting for covariates. A Bonferroni adjustment will be used to account for the simultaneous testing of 10 SNPs; a one-sided p-value of 0.0025 will be considered statistically significant. | Up to 1 year | |
Secondary | Presence of SNPs in the estrogen receptor alpha (ESR), T-cell leukemia/lymphoma 1A (TCL1A), and CYP19A1 genes | Correlations among SNPs will be estimated, and linkage disequilibrium among pairs of SNPs will be characterized. Logistic regression models, with treatment discontinuation as the outcome variable, will be used to explore the association with SNPs, adjusting for important clinical factors. | Up to 1 year | |
Secondary | Proportions of patients with treatment discontinuation for any reason | Explored using proportional hazards models adjusting for significant genotypic and clinical predictors. Kaplan-Meier plots will be used to graphically portray the associations. | Up to 1 year | |
Secondary | Proportion of patients with symptoms determined not to be from other known etiologies as assessed by the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) and Breast subscale | Explored using proportional hazards models adjusting for significant genotypic and clinical predictors. Kaplan-Meier plots will be used to graphically portray the associations. | Up to 1 year | |
Secondary | Proportion of patients whose symptoms improve when the AI is discontinued | Up to 1 year | ||
Secondary | Time to discontinuation of treatment | Explored using proportional hazards models adjusting for significant genotypic and clinical predictors. Kaplan-Meier plots will be used to graphically portray the associations. | Up to 1 year | |
Secondary | Time to development of symptoms | Explored using proportional hazards models adjusting for significant genotypic and clinical predictors. Kaplan-Meier plots will be used to graphically portray the associations. | Up to 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02235051 -
Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors
|
N/A | |
Terminated |
NCT02454777 -
High-Intensity Interval Training for Stage I-III Breast Cancer Patients
|
N/A | |
Completed |
NCT03061175 -
Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy
|
N/A | |
Completed |
NCT01959490 -
Trastuzumab and Pertuzumab or Bevacizumab With Combination Chemotherapy in Treating Patients With Stage II-III Breast Cancer
|
Phase 2 | |
Recruiting |
NCT03156309 -
Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission
|
Phase 1 | |
Completed |
NCT01928186 -
FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer
|
N/A | |
Terminated |
NCT01368263 -
Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer
|
Phase 2 | |
Terminated |
NCT01222377 -
Endoscopic Breast Surgery in Treating Patients With Breast Cancer
|
N/A | |
Completed |
NCT00425672 -
ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment
|
Phase 1/Phase 2 | |
Completed |
NCT00070252 -
Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT02780401 -
Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission
|
Phase 1 | |
Completed |
NCT02728596 -
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
|
N/A | |
Completed |
NCT01478477 -
Omega-3 Fatty Acids in Preventing Joint Symptoms in Patients With Stage I-III Breast Cancer Receiving Anastrozole, Exemestane, or Letrozole
|
N/A | |
Completed |
NCT03364348 -
4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
|
Phase 1 | |
Completed |
NCT02897375 -
Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
|
Phase 1 | |
Withdrawn |
NCT01695057 -
Vorinostat Before Surgery in Treating Patients With Triple-Negative Breast Cancer
|
N/A | |
Completed |
NCT01672684 -
Phase I: At-Home Support for Rural Women Using Group Video Calling
|
Phase 1 | |
Terminated |
NCT01233505 -
Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Terminated |
NCT01234532 -
Entinostat and Anastrozole in Treating Postmenopausal Women With TNBC That Can Be Removed by Surgery
|
Phase 2 | |
Completed |
NCT00416715 -
Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer
|
Phase 2 |