Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2024-02-01
2025-01-01
Brief Summary
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PURPOSE: the study is to explore the effects of the 4 Herbs Formula on the reduction of "Skeletal-related events" (SRES), and survival time.
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Detailed Description
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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 Life: EQ5-D Pain control (Brief Pain Inventory)
OUTLINE:
Patients will be randomized to receive either 4 herbs formula plus Zometa or Zometa alone after all the eligibility criteria have been fulfilled and informed consent has been signed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Study group
Herbal formula 5g daily, and Zometa
4 Herbs Formula
4 herbs formula dose: 5g/day
Control group
Zometa alone
4 Herbs Formula
4 herbs formula dose: 5g/day
Interventions
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4 Herbs Formula
4 herbs formula dose: 5g/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Cheng King Fai
Principal Investigator
Other Identifiers
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2021.746-T
Identifier Type: -
Identifier Source: org_study_id
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