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A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)


N/A
18 Years
N/A
Not Enrolling
Female
Estrogen Receptor-positive Breast Cancer, Musculoskeletal Complications, Progesterone Receptor-positive Breast Cancer, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Thank you

Trial Information

A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)


PRIMARY OBJECTIVES:

I. 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:

I. 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.

V. 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Discontinuation of treatment following development of AIMSS determined by scores on the Health Assessment Questionnaire (HAQ) instrument

Outcome Description:

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.

Outcome Time Frame:

Up to 1 year

Safety Issue:

No

Principal Investigator

Vered Stearns

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

E1Z11

NCT ID:

NCT01824836

Start Date:

July 2013

Completion Date:

Related Keywords:

  • Estrogen Receptor-positive Breast Cancer
  • Musculoskeletal Complications
  • Progesterone Receptor-positive Breast Cancer
  • Recurrent Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Breast Neoplasms

Name

Location
Veterans Adminstration New Jersey Health Care System East Orange, New Jersey  07018-1095
Eastern Cooperative Oncology Group Boston, Massachusetts  02215