Clinical trial NCT01129336: Effect of Zoledronic Acid as Anti-Cancer Treatment in Metastatic Breast Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: First or Second Line HER2-negative Breast Cancer
Metastatic Disease Without Bone Metastasis
Keywords: 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
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-05-24
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Progression Free Survival (PFS)
timeFrame: up to 18 months
Secondary outcomes:
measure: Percentage of Patients With Circulating Tumor Cell Levels of at Least 5 Per 7.5 mL of Peripheral Blood by Month
timeFrame: Baseline, Month 1, 2, 4, 6, 9 and 18
measure: Time to Progression (TTP)
timeFrame: up to 18 months
measure: Change From Baseline in Urine NTX by Month
timeFrame: Baseline, Month 2, Month 4
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Jonesboro
country: United States
facility: Clopton Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Hematology Oncology Services of Arkansas
state: Arkansas
city: Anaheim
country: United States
facility: Kaiser Permanente Medical Group Kaiser Permanente - Hawaii
state: California
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Loma Linda Cancer Center
state: California
city: Waterbury
country: United States
facility: Hematology and Medical Oncology
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists DeptofFloridaCancerSpecialists
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center Dept. of Lakeland Regional
state: Florida
city: Titusville
country: United States
facility: Space Coast Medical Associates
state: Florida
city: Coeur d'Alene
country: United States
facility: Kootenai Medical Center Kootenai Medical Center
state: Idaho
city: Park Ridge
country: United States
facility: Oncology Specialists, SC Lutheran General Cancer Instit
state: Illinois
city: Witchita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: St. Louis Park
country: United States
facility: Park Nicollet Institute Dept. of Park Nicollet
state: Minnesota
city: St. Louis
country: United States
facility: St. John's Mercy Medical Center St. John's Mercy Med Ctr
state: Missouri
city: Billings
country: United States
facility: Hematology Oncology Centers of the Northern Rockies Hema Onc Ctr N. Rockies (4
state: Montana
city: Lincoln
country: United States
facility: Southeast Nebraska Oncology Cancer Center
state: Nebraska
city: Reno
country: United States
facility: Reno Oncology Consultants
state: Nevada
city: Somerset
country: United States
facility: Somerset Hematology Oncology Associates Somerset Hema Oncol Assoc (2)
state: New Jersey
city: Voorhees
country: United States
facility: Cooper Cancer Center
state: New Jersey
city: Lake Success
country: United States
facility: NYU Langone Arena Oncology
state: New York
city: Washington
country: United States
facility: Marion L. Shepard Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Hematology and Oncology Associates Piedmont Hem/Onc Assoc (2)
state: North Carolina
city: Elyria
country: United States
facility: Hematology Oncology Center, Inc.
state: Ohio
city: Hershey
country: United States
facility: Milton S Hershey Medical Center Hershey Medical Center (4)
state: Pennsylvania
city: West Reading
country: United States
facility: Berks Hematology Oncology
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Hematology Oncology Associates, Inc
state: Pennsylvania
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: San Antonio
country: United States
facility: South Texas Oncology and Hematology, PA South Texas Oncology (2)
state: Texas
city: Tyler
country: United States
facility: East Texas Medical Center Cancer Institute Tyler Hem/Onc (3)
state: Texas
city: Reston
country: United States
facility: Medical Oncology & Hematology Associates of Northern VA Med. Onc&Hem Assoc. of No.VA
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: