Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Musculoskeletal Diseases

Blood and Lymph Conditions

Breast Neoplasms

Neoplasm Metastasis

Disease Progression

Neoplastic Cells, Circulating

Bone Neoplasms

Bone Marrow Diseases

Breast Diseases

Skin Diseases

Neoplastic Processes

Bone Diseases

Hematologic Diseases

Bone Density Conservation Agents

All Drugs and Chemicals

Zoledronic Acid

Diphosphonates

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.

Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)

Patients with no bone metastasis (n=150) will receive Standard therapy plus Zoledronic acid administration 4 mg IV monthly during Months 1-18.

Zoledronic acid

Standard Therapy, including chemotherapy and hormonal therapy, was determined at the discretion of the investigator.

Standard Therapy

Novartis Pharmaceuticals

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.

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

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

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.

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 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.

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.

Patients Without Bone Metastases

Patients With Bone Metastases

Total

Age, Continuous

Sex: Female, Male

Study Director

Event

Censor

All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug.

Number of Participants With Progression Free Survival (PFS)

Baseline (n=15,28)

Month 1 (n=8,0)

Month 2 (n=12,24)

Month 4 (n=8,20)

Month 6 (n=7,19)

Month 9 (n=2,14)

Month 18 (n=2,1)

All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug. "n" in each category represents the number of patients with non-missing CTC values.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effect of Zoledronic Acid as Anti-Cancer Treatment in Metastatic Breast Cancer Patients	NCT01129336	First or Second... Metastatic Dise...	Zoledronic acid Standard Therap...	18 Years -	Novartis
Effect of Zoledronic Acid as Anti-Cancer Treatment in Metastatic Breast Cancer Patients	NCT01129336	First or Second... Metastatic Dise...	Zoledronic acid Standard Therap...	18 Years -	Novartis

Spots Global Cancer Trial Database for metastatic disease without bone metastasis