Effect of Zoledronic Acid as Anti-Cancer Treatment in Metastatic Breast Cancer Patients

Completed · Phase 4

Conditions studied: First or Second Line HER2-negative Breast Cancer, Metastatic Disease Without Bone Metastasis

In brief

This study will evaluate zoledronic acid's anti-cancer effects and Circulating Tumor Cell (CTCs) measurements in patients with HER2-negative metastatic breast cancer without bone metastasis.

Key facts

Study ID

NCT01129336

Run by

Novartis Pharmaceuticals

People needed

44

Starts

2010-06-01

Expected to finish

2012-08-01

Last updated by the study team

2014-05-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent
• Female patients (age ≥18 years)
• HER2-negative metastatic breast cancer (stage IV)
• Patients will be receiving chemotherapy or hormonal therapy
• Patients with no bone metastasis and ≤1 prior treatments for metastatic breast cancer. Patients with newly diagnosed metastatic breast cancer may have received adjuvant or neoadjuvant chemotherapy as long as treatment was completed ≥12 months prior to relapse.
• Asymptomatic brain metastasis is permitted if all of the following criteria are met:
• no sign of clinical progression or known progression of brain metastasis
• off steroids for at least 2 weeks prior to study enrollment
• Stable renal function: two serum creatinine determinations of <3 mg/dL, obtained no less than 7 days apart (one value may be obtained within 6 weeks prior to Screening; the second must be obtained during Screening)
• ECOG performance status of 0 or 1
• Life expectancy of ≥ 6 months
• Negative serum pregnancy test
• Ability and willingness to comply with all study requirements

You may not qualify if…

• Known hypersensitivity to zoledronic acid or other bisphosphonates
• Patients with history of another malignancy within the last two years prior to study enrollment, except cured basal cell carcinoma of the skin or excised carcinoma in site of the cervix
• Use of concurrent investigational agents is prohibited. Prior use of investigational agents is permitted if discontinued ≥30 days prior to Screening.
• No prior therapy with an antiresorptive agent
• Patients with active brain metastases or meningeal metastases
• Current or recent (in the six months prior to initial study drug treatment) severe cardiovascular disease (defined as uncontrolled congestive heart failure), hypertension refractory to treatment, or poorly controlled Type I/II diabetes mellitus
• Current active dental problems including dental abscess or infection of the jawbone (maxilla or mandible) or a current or prior diagnosis of osteonecrosis of the jaw
• Patients who have received radiotherapy ≤ 4 weeks prior to study enrollment or who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions ≤ 2 weeks prior to study enrollment is allowed
• Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) ≤ 4 weeks prior to study enrollment or who have not recovered from side effects of such therapy
• Diminished renal capacity: calculated creatinine clearance (CrCl) <30 mL/min (based on Cockcroft-Gault formula)
• Corrected (i.e., adjusted for serum albumin) serum calcium of <8.0 mg/dL (2.00 mmol/L) or ≥ 12 mg/dL (3.00 mmol/L)
• Pregnant or breast-feeding females
• Women of child-bearing potential who are not willing/able to use effective methods of birth control (e.g., abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)
• History of non-compliance to medical regimens and/or patients who are considered unreliable
• History of bone metabolism diseases

Where it is running

• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Clopton Clinic — Jonesboro, Arkansas, United States
• Hematology Oncology Services of Arkansas — Little Rock, Arkansas, United States
• Kaiser Permanente Medical Group Kaiser Permanente - Hawaii — Anaheim, California, United States
• Wilshire Oncology Medical Group — La Verne, California, United States
• Loma Linda University Loma Linda Cancer Center — Loma Linda, California, United States
• Hematology and Medical Oncology — Waterbury, Connecticut, United States
• Florida Cancer Specialists DeptofFloridaCancerSpecialists — Fort Myers, Florida, United States
• Lakeland Regional Cancer Center Dept. of Lakeland Regional — Lakeland, Florida, United States
• Space Coast Medical Associates — Titusville, Florida, United States
• Kootenai Medical Center Kootenai Medical Center — Coeur d'Alene, Idaho, United States
• Oncology Specialists, SC Lutheran General Cancer Instit — Park Ridge, Illinois, United States
• Cancer Center of Kansas — Witchita, Kansas, United States
• Park Nicollet Institute Dept. of Park Nicollet — Saint Louis Park, Minnesota, United States
• St. John's Mercy Medical Center St. John's Mercy Med Ctr — St Louis, Missouri, United States
• Hematology Oncology Centers of the Northern Rockies Hema Onc Ctr N. Rockies (4 — Billings, Montana, United States
• Southeast Nebraska Oncology Cancer Center — Lincoln, Nebraska, United States
• Reno Oncology Consultants — Reno, Nevada, United States
• Somerset Hematology Oncology Associates Somerset Hema Oncol Assoc (2) — Somerset, New Jersey, United States
• Cooper Cancer Center — Voorhees Township, New Jersey, United States
• NYU Langone Arena Oncology — Lake Success, New York, United States
• Marion L. Shepard Cancer Center — Washington, North Carolina, United States
• Piedmont Hematology and Oncology Associates Piedmont Hem/Onc Assoc (2) — Winston-Salem, North Carolina, United States
• Hematology Oncology Center, Inc. — Elyria, Ohio, United States
• Milton S Hershey Medical Center Hershey Medical Center (4) — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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