Effect of Zoledronic Acid as Anti-Cancer Treatment in Metastatic Breast Cancer Patients (MACS1295)
|ClinicalTrials.gov Identifier: NCT01129336|
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : February 12, 2014
Last Update Posted : May 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|First or Second Line HER2-negative Breast Cancer Metastatic Disease Without Bone Metastasis||Drug: Zoledronic acid Drug: Standard Therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2010|
|Primary Completion Date :||August 2012|
|Study Completion Date :||August 2012|
Experimental: Patients without bone metastases
Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
Drug: Zoledronic acid
Patients with no bone metastasis (n=150) will receive Standard therapy plus Zoledronic acid administration 4 mg IV monthly during Months 1-18.
Experimental: Patients with bone metastases
Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
Drug: Standard Therapy
Standard Therapy, including chemotherapy and hormonal therapy, was determined at the discretion of the investigator.
- Number of Participants With Progression Free Survival (PFS) [ Time Frame: up to 18 months ]Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have exhibited a reduction in short axis to < 10 mm. Partial Response (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): at least 20% increase in sum of diameters of target lesions taking as reference the smallest sum on study accompanied by an absolute increase of at least 5 mm or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PFS is time from enrollment to date of first documented disease progression or death due to any cause. A participant is considered to be censored when data on time to event is missing due to a subject being lost to follow-up or non-occurrence of the outcome event before the completion of the trial.
- Percentage of Patients With Circulating Tumor Cell Levels of at Least 5 Per 7.5 mL of Peripheral Blood by Month [ Time Frame: Baseline, Month 1, 2, 4, 6, 9 and 18 ]Circulating tumor cells (CTCs) have been associated with poor patient prognosis and outcomes in patients receiving treatment for MBC. CTCs have been evaluated as a potential biomarker for predicting treatment effects and overall survival. Baseline was defined as the last predose measurement for patients who received any study drug and as the later of the screening visit or Visit 2 value for patients who did not receive the study drug. Percentage was calculated as the number of patients with CTC ≥5/7.5 mL against the number of patients with nonmissing CTC values (represented as 'n' in the categories).
- Time to Progression (TTP) [ Time Frame: up to 18 months ]Time to progression is defined as the time from the date of enrollment to the date of first documented disease progression or death due to metastatic breast cancer.
- Change From Baseline in Urine NTX by Month [ Time Frame: Baseline, Month 2, Month 4 ]NTX= N-telopeptide of type 1 collagen (nmol bce/mmol [nanomoles of bone collagen equivalents per millimole of creatinine]). Baseline was defined as the last predose measurement for patients who received any study drug and as the later of the screening visit or visit 2 value for patients who did not receive study drug.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129336
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|