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A Multicenter, Open-label, Randomized Trial to Evaluate the Anti-cancer Effects of Zoledronic Acid and Circulating Tumor Cell Measurements in Patients With HER2-negative Metastatic Breast Cancer Without Bone Metastasis


Phase 4
18 Years
N/A
Not Enrolling
Female
First or Second Line HER2-negative Breast Cancer, Metastatic Disease Without Bone Metastasis

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Trial Information

A Multicenter, Open-label, Randomized Trial to Evaluate the Anti-cancer Effects of Zoledronic Acid and Circulating Tumor Cell Measurements in Patients With HER2-negative Metastatic Breast Cancer Without Bone Metastasis


Inclusion Criteria:



- 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:

1. no sign of clinical progression or known progression of brain metastasis

2. 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS)

Outcome Time Frame:

up to 18 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CZOL446EUS147

NCT ID:

NCT01129336

Start Date:

June 2010

Completion Date:

August 2012

Related Keywords:

  • First or Second Line HER2-negative Breast Cancer
  • Metastatic Disease Without Bone Metastasis
  • HER2-negative
  • HER2
  • Metastatic breast cancer
  • First Line breast cancer
  • Second Line breast cancer
  • Breast cancer
  • Metastatic
  • Stage IV breast cancer
  • Progression free survival
  • PFS
  • Circulating Tumor Cells
  • CTCs
  • Zoledronic acid
  • HER2-negative metastatic breast cancer patients without bone metastasis
  • Breast Neoplasms
  • Neoplastic Cells, Circulating
  • Neoplasm Metastasis
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

Highlands Oncology GroupSpringdale, Arkansas  72764
Hematology Oncology Services of ArkansasLittle Rock, Arkansas  72205
Wilshire Oncology Medical GroupGlendora, California  91741
The West ClinicMemphis, Tennessee  38120
Northwest Medical SpecialtiesTacoma, Washington  98405
Cooper Cancer CenterVoorhees, New Jersey  08043
Space Coast Medical AssociatesCocoa Beach, Florida  32931
Cancer Center of KansasWichita, Kansas  67214
Sarah Cannon Research InstituteNashville, Tennessee  37203
Marion L. Shepard Cancer CenterWashington, North Carolina  
Arena Oncology Associates, PCGreat Neck, New York  11021
Clopton ClinicJonesboro, Arkansas  72401
Berks Hematology OncologyWest Reading, Pennsylvania  19611
South Texas Oncology and Hematology, PA South Texas Oncology (2)San Antonio, Texas  78258
Florida Cancer Specialists DeptofFloridaCancerSpecialistsFort Myers, Florida  33901
Park Nicollet Institute Dept. of Park NicolletSt. Louis Park, Minnesota  55416
Kootenai Medical Center Kootenai Medical CenterCoeur d'Alene, Idaho  83814
Hematology Oncology Center, Inc.Elyria, Ohio  44035
Abington Hematology Oncology Associates, IncWillow Grove, Pennsylvania  19090
Southeast Nebraska Oncology Cancer CenterLincoln, Nebraska  68510
Somerset Hematology Oncology Associates Somerset Hema Oncol Assoc (2)Somerset, New Jersey  08873
Kaiser Permanente Medical Group Kaiser Permanente - HawaiiAnaheim, California  92807
Loma Linda University Loma Linda Cancer CenterLoma Linda, California  92354
Hematology and Medical OncologyWaterbury, Connecticut  06708
Lakeland Regional Cancer Center Dept. of Lakeland RegionalLakeland, Florida  33803
Oncology Specialists, SC Lutheran General Cancer InstitPark Ridge, Illinois  60068-0736
St. John's Mercy Medical Center St. John's Mercy Med CtrSt. Louis, Missouri  63141
Hematology Oncology Centers of the Northern Rockies Hema Onc Ctr N. Rockies (4Billings, Montana  59101
Reno Oncology ConsultantsReno, Nevada  89502
Piedmont Hematology and Oncology Associates Piedmont Hem/Onc Assoc (2)Winston-Salem, North Carolina  27103
Milton S Hershey Medical Center Hershey Medical Center (4)Hershey, Pennsylvania  17033
East Texas Medical Center Cancer Institute Tyler Hem/Onc (3)Tyler, Texas  75701
Medical Oncology & Hematology Associates of Northern VA Med. Onc&Hem Assoc. of No.VAReston, Virginia  20190