Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Breast Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Only males
Description
Metastatic breast cancer (MBC) is incurable. Although first-line endocrine therapy is preferred to hormone receptor positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) MBC, chemotherapy may be reserved as the initial treatment for patients with rapid clinical progression, life-...
Metastatic breast cancer (MBC) is incurable. Although first-line endocrine therapy is preferred to hormone receptor positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) MBC, chemotherapy may be reserved as the initial treatment for patients with rapid clinical progression, life-threatening visceral metastases, and need for rapidly symptom control. Either prolonged chemotherapy or endocrine therapy may be used as maintenance after disease control. However, which maintenance strategy is superior in terms of delaying disease progression as well as maintaining quality of life (QOL) remains uncertain. This phase III trial aims to compare the efficacy and safety of fulvestrant or capecitabine as maintenance therapy after first-line chemotherapy in HR+/HER2- MBC.
Tracking Information
- NCT #
- NCT04263298
- Collaborators
- Sun Yat-sen University
- First Affiliated Hospital, Sun Yat-Sen University
- Peking University Shenzhen Hospital
- Guangdong Provincial People's Hospital
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Study Chair: Herui Yao, PhD Sun Yat-sen Memorial Hospital,Sun Yat-sen University Principal Investigator: Shusen Wang, PhD Sun Yat-sen University Principal Investigator: Kun Wang, PhD Guangdong Provincial People's Hospital Principal Investigator: Qianjun Chen, PhD Guangdong Provincial Hospital of Traditional Chinese Medicine Principal Investigator: Ruilian Xu, Master Shenzhen People's Hospital Principal Investigator: Peijian Peng, PhD Fifth Subsidiary Sun Yat-sen University Hospital Principal Investigator: Li Ling, PhD Public Health Institute of Sun Yat-sen University
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