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
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 44
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: 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. arm 2: Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)

Interventions: intervention 1: Zoledronic acid intervention 2: Standard Therapy
Intervention descriptions: intervention 1: Patients with no bone metastasis (n=150) will receive Standard therapy plus Zoledronic acid administration 4 mg IV monthly during Months 1-18. intervention 2: Standard Therapy, including chemotherapy and hormonal therapy, was determined at the discretion of the investigator.

Protocol document: