Anastrozole in Treating Aromatase Inhibitor Musculoskeletal Symptoms in Female Patients with Stage I-III Breast Cancer

Status: Closed to Accrual

Description

This pilot clinical trial studies anastrozole in treating aromatase inhibitor musculoskeletal symptoms in female patients with stage I-III breast cancer. Anastrozole may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

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
  • NOTE: use of luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide or goserelin) is not allowed
  • Patients must have estrogen and/or progesterone receptor positive histologically confirmed stage I-III adenocarcinoma of the breast
  • Patients must have completed planned local therapy (i.e., definitive surgery and radiation therapy) and adjuvant chemotherapy for breast cancer prior to registration; in addition, any prior local therapy and adjuvant chemotherapy should be completed prior to participant completion of baseline Patient Reported Outcomes (PRO) instruments (i.e., Health Assessment Questionnaire [HAQ], PROMIS Physical Function, Functional Assessment of Cancer Therapy [FACT] Breast and Endocrine Symptoms [ES], etc.) and collection of optional blood for banking for future research
  • NOTE: concomitant treatment with ongoing trastuzumab (Herceptin) or other targeted/biologic agents is allowed; concomitant treatment with any other type of chemotherapy or hormonal therapy is not allowed
  • Patients must not have received prior AI therapy with exemestane, letrozole, or anastrozole as preoperative/adjuvant therapy or for prevention of breast cancer; prior tamoxifen is allowed
  • 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 not be currently taking (or have taken in the past 6 months) medication for active, chronic conditions, including rheumatoid arthritis, carpal tunnel syndrome, tenosynovitis, systemic lupus erythematosus, gout, fibromyalgia, or severe osteoarthritis involving the hands, wrists, hips, knees, feet or ankles; this includes analgesic medications or medications being taken with the purpose of treating pain or that may have an effect on pain (e.g. anti-depressants for help with pain or neuropathy, corticosteroid shots for arthritis); (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 no worse than 3 out of 10 on the following question (i.e., a pain score of 0, 1, 2, or 3): “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 question may be asked orally prior to consent up to 7 days prior to registration; the response will be recorded on the registration checklist
  • Patients must have adequate hepatic, hematologic and renal functioning to be able to be administered anastrozole at the discretion of the treating physician

Locations & Contacts

Delaware

Newark
Christiana Gynecologic Oncology LLC
Status: Temporarily closed to accrual
Contact: Gregory Andrew Masters
Phone: 302-733-6227

Indiana

South Bend
Michiana Hematology Oncology PC-South Bend
Status: Temporarily closed to accrual
Contact: Jose A. Bufill
Phone: 574-237-1328

Kansas

Wichita
Wichita NCI Community Oncology Research Program
Status: Active
Contact: Shaker R. Dakhil
Phone: 316-268-5374

Michigan

Iron Mountain
Green Bay Oncology - Iron Mountain
Status: Temporarily closed to accrual
Contact: Brian Leslie Burnette
Phone: 920-433-8889

Minnesota

Saint Louis Park
Metro Minnesota Community Oncology Research Consortium
Status: Active
Contact: Joseph W. Leach
Phone: 952-993-1517
Email: mmcorc@parknicollet.com

Nebraska

Omaha
Missouri Valley Cancer Consortium
Status: Active
Contact: Gamini S. Soori
Phone: 402-991-8070ext202
Email: mwilwerding@mvcc.cc

North Carolina

Hendersonville
Hendersonville Hematology and Oncology at Pardee
Status: Temporarily closed to accrual
Contact: James Earl Radford
Phone: 828-696-4716

North Dakota

Fargo
Sanford Clinic North-Fargo
Status: Temporarily closed to accrual
Contact: Preston D. Steen
Phone: 712-252-0088

Wisconsin

Green Bay
Green Bay Oncology at Saint Vincent Hospital
Status: Active
Contact: Brian Leslie Burnette
Phone: 920-433-8889
Green Bay Oncology Limited at Saint Mary's Hospital
Status: Active
Contact: Brian Leslie Burnette
Phone: 920-433-8889
Sturgeon Bay
Green Bay Oncology - Sturgeon Bay
Status: Active
Contact: Brian Leslie Burnette
Phone: 920-433-8889

Trial Objectives and Outline

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), glucuronosyltransferase (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 once a year for up to 5 years.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Supportive care

Lead Organization

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Vered Stearns

Trial IDs

Primary ID E1Z11
Secondary IDs ECOG-E1Z11, NCI-2013-00426
Clinicaltrials.gov ID NCT01824836