Featured Clinical Trial:
Zoledronic Acid as Anti-Cancer Treatment in Metastatic Breast Cancer Patients (product/compound: Z-ACT 1)
ClinicAid Locations: Southern California – Fountain Valley, Corona, Riverside
Status:
Open for enrollment (accepting patients). Please contact us and mention Trial ID NCT01129336.
Condition: HER2-negative Breast Cancer Metastatic Disease
Product Name/Compound: Zoledronic acid, ZACT-1
Full Study Title: A Multicenter, Open-label, Randomized Trial to Evaluate the Anti-cancer Effects of Zoledronic Acid Using Circulating Tumor Cell Measurements in Patients With Newly Diagnosed HER2-negative Metastatic Breast Cancer
Study Summary: This study will evaluate zoledronic acid's anti-cancer effects using Circulating Tumor Cell measurements in patients with newly diagnosed HER2-negative metastatic breast cancer.
Eligible Participants:
Inclusion (Eligible):
- Written informed consent
- Female patients (age ≥ 18 years)
- HER2-negative metastatic breast cancer (stage IV)
- Patients will be receiving chemotherapy with bevacizumab, chemotherapy without bevacizumab, or hormonal therapy
- No prior therapy with intravenous bisphosphonates. Prior therapy with oral bisphosphonates is permitted if treatment was completed ≥ 6 months prior to Screening.
- No prior chemotherapy or hormonal therapy for metastatic breast cancer is permitted. Patients may have received adjuvant or neoadjuvant chemotherapy (with or without bevacizumab) as long as treatment was completed ≥ 12 months prior to relapse. Prior hormonal therapy in the adjuvant setting will be permitted.
- Asymptomatic brain metastasis is permitted if all of the following criteria are met:
- at least 4 weeks after completion of radiation or surgical treatment prior to study entry
- residual symptoms <grade 2
- no dexamethasone requirement
- follow-up MRI shows regression of lesions ≥4 weeks after treatment and no new lesions appearing
- CTCs ≥1/7.5 mL blood
- 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 (Not Eligible):
- Known hypersensitivity to zoledronic acid or other bisphosphonates
- Use of concurrent investigational agents is prohibited. Prior use of investigational agents is permitted if discontinued ≥30 days prior to Screening.
- 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
- Recent (within 4 weeks) or planned dental or jaw surgery. Recent dental fillings, teeth scaling, polishing or minor gingival surgery do not exclude the patient.
- 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
Study Phase: Phase IV (What are Phases?)
To receive information and updates for this trial:
Please contact us and mention the Trial ID below.
Trial ID (ClinicalTrials.gov): NCT01129336
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