Status:
COMPLETED
Zoledronic Acid in Aromatase Inhibitor Induced Musculoskeletal Symptoms
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Ductal Carcinoma in Situ
Estrogen Receptor-positive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Zoledronic acid may prevent bone loss and help prevent or lessen musculoskeletal symptoms in women receiving hormone therapy for breast cancer. PURPOSE: This phase II trial is studying how...
Detailed Description
PRIMARY OBJECTIVES: I. Percentage of women experiencing aromatase inhibitor associated musculoskeletal symptoms (AIMSS) at 1, 3, 6, and 12 months after bisphosphonate therapy, as compared to historic...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients with histologically proven DCIS or stage I-III invasive carcinoma of the breast that is estrogen and/or progesterone receptor positive by immunohistochemical staining who are considering aromatase inhibitor therapy; women may receive the AI on this study as initial adjuvant hormonal treatment or following tamoxifen; patients must have completed any adjuvant chemotherapy; patients may have received preoperative chemotherapy
- Postmenopausal status, defined as: \>= 60 years of age; or \< 60 years of age and amenorrheic for \>= 12 months prior to day 1 if intact uterus/ovaries; 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 (FSH and estradiol within institutional standards 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; or prior radiation castration with amenorrhea for at least 6 months; \< 60 years of age and taking medication designed to suppress ovarian function and meets biochemical criteria for menopause (estradiol levels within institutional standards for postmenopausal status; women would have had to be taking the drug for at least 30 days prior to day 1)
- ECOG performance status 0-2
- Patient is aware of the nature of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form
- Exclusion Criteria
- Concurrent use of hormone replacement therapy
- Concurrent use of tamoxifen; patients taking tamoxifen must discontinue the drug prior to first dose of zoledronic acid
- Concurrent use of other selective estrogen receptor modulator (SERM) such as raloxifene
- Concurrent consumption of soy supplements; routine dietary consumption of soy containing foods will be permitted
- Prior use of an aromatase inhibitor in any setting
- Current bisphosphonate use (oral or intravenous); prior bisphosphonate users would be eligible as long as the use was \> 1 month ago for oral bisphosphonates and/or \> 12 months ago for intravenous bisphosphonates, prior to starting study treatment
- Moderate to severe renal impairment (serum creatinine greater than 2 mg/dL or creatinine clearance less than 50 mL/min)
- Hypersensitivity to letrozole or zoledronic acid or any of its excipients
- Concomitant treatment with oral or intravenous corticosteroids
- Current active dental problems including infection or the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures
- Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
Exclusion
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01194440
Start Date
February 1 2011
End Date
January 1 2014
Last Update
September 12 2018
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287-8936