Zoledronic Acid in Aromatase Inhibitor Induced Musculoskeletal Symptoms
Condition: Ductal Carcinoma in Situ; Estrogen Receptor-positive Breast Cancer; Progesterone Receptor-positive Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
MeSH terms: Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
Intervention: letrozole; zoledronic acid
Intervention description: Given orally; Given IV
Intervention MeSH terms: Zoledronic Acid; Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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 well zoledronic acid works in preventing
      musculoskeletal symptoms in post-menopausal women with stage I, stage II, or stage III breast
      cancer receiving letrozole.
    

Eligibility criteria:

        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)