Status:
UNKNOWN
Efficacy of a Herbal Formula for Bone Metastases
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Bone Metastases
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Nearly 50% of patients with bone metastases develop one or more complications collectively termed skeletal-related events (SREs). The study herbal medicine might reduce the morbidities due ...
Detailed Description
OBJECTIVES: Primary Primary efficacy end points are SRE, general state and biomarkers. Secondary Survival rate and survival time Time to first SRE (since randomization) Biochemical markers Quality of...
Eligibility Criteria
Inclusion
- Aged 18 years or older
- Breast cancer bone metastasis-no supplementary treatment or hormonal treatment alone
- Confirmed diagnosis of metastatic breast cancer
- Radiographic proof of metastatic bone disease
- Informed consent obtained
Exclusion
- Known history of primary bone tumors (benign and/or malignant)
- Prior use of bone modifying agents, including but not limited to zoledronic acid or denosumab within 12 months of study entry
- Active anti-cancer therapies in the form of cytotoxics or targeted therapies. \[Patients who are currently on hormonal therapies, including but not limited to tamoxifen, aromatase inhibitors and LHRH agonists/antagonists are allowed for study entry. Clarifications shall be sought from investigators if in doubt\].
- Significant drug hypersensitivity
- No informed consent signed
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06023420
Start Date
February 1 2024
End Date
January 1 2025
Last Update
September 7 2023
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