Multicenter, Open-label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-symptomatic Bone Lesions
Overview
- Phase
- Phase 3
- Intervention
- Zoledronic acid
- Conditions
- Breast Cancer
- Sponsor
- Spanish Breast Cancer Research Group
- Enrollment
- 97
- Locations
- 1
- Primary Endpoint
- Time to first bone metastases
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
This is an open-label, randomized, multicenter phase III trial to assess the efficacy of early administration of zoledronate versus observation in delaying bone-related symptoms in metastatic breast cancer patients.
Detailed Description
Patients will be randomised to receive 4 mg zoledronate every 3-4 weeks versus observation until bone-related symptoms appear, or up to 12 months. One hundred twelve patients per treatment arm will be enrolled in the study. Once bone-related symptoms appear, study participation is over. During the study, the following will be assessed: * quality of life, * performance status, * pain rating, * analgesic administration and * adverse events The principal objective is the delay in bone-related symptoms in those patients with early zoledronate administration.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent.
- •Age \>= 18 years old.
- •Metastatic breast cancer patients with lytic, sclerotic or mixed bone lesions.
- •Non-symptomatic bone lesions, defined as pain absence, lack of bone complications (fracture, hypercalcemia, Central Nervous System (CNS) compression), no need of analgesic chronic administration for bone disease.
- •A maximum of two chemotherapy lines for metastatic disease.
- •A maximum of two hormone therapy lines for metastatic disease.
- •Normal, minimally altered renal function (serum creatinine \< 1.5 x Upper Normal Limit (UNL)).
- •Normal serum calcium levels.
- •Performance status 0,1 (World Health Organization (WHO)).
- •Negative pregnancy test before study recruitment.
Exclusion Criteria
- •Previous treatment with bisphosphonates or raloxifene in the 30 days prior to randomization.
- •Metastasis in CNS.
- •History of hypersensitivity to bisphosphonates.
- •Pregnant or lactating women.
- •Third chemotherapy line for metastatic disease.
- •Third hormone therapy line for metastatic disease.
Arms & Interventions
Arm A: Zoledronic acid 4 mg
Zoledronate 4 mg every 3 or 4 weeks. This arm will receive study treatment from the time of entry into the trial, until the appearance of the symptoms of bone metastases (or a maximum period of 12 months, whichever occurs first).
Intervention: Zoledronic acid
Outcomes
Primary Outcomes
Time to first bone metastases
Time Frame: Up to disease progression
The main variable of evaluation is the time until the appearance of first bone metastases.
Secondary Outcomes
- The Number of Participants Who Experienced Adverse Events (AE)(Through study treatment)
- Quality of life per treatment arm(Up to disease progression)