Spots Global Cancer Trial Database for Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer
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Trial Identification
Brief Title: Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer
Official Title: A Randomized, Multi-center, Open-label, Phase III Trial of Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer (FAMILY)
Study ID: NCT04263298
Conditions
Study Description
Brief Summary: This phase III trial aims to compare the efficacy and safety of fulvestrant or capecitabine as maintenance therapy after first-line chemotherapy in hormone receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer.
Detailed 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-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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Public Health Institute of Sun Yat-sen University, Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
Shantou Central Hospital, Shantou, Guangdong, China
Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen, Guangdong, China
Shenzhen People's Hospital, Shenzhen, Guangdong, China
Affiliated Hospital of Guangdong Medical University, Zhangjiang, Guangdong, China
Fifth Subsidiary Sun Yat-sen University Hospital, Zhuhai, Guangdong, China
Affiliated Cancer Hospital of Guangxi Medical University, Nanning, Guangxi, China
Hunan Cancer Hospital, Changsha, Hunan, China
Contact Details
Name: Herui Yao, PhD
Affiliation: Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Role: STUDY_CHAIR
Name: Shusen Wang, PhD
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
Name: Kun Wang, PhD
Affiliation: Guangdong Provincial People's Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Peijian Peng, PhD
Affiliation: Fifth Subsidiary Sun Yat-sen University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Li Ling, PhD
Affiliation: Public Health Institute of Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
Name: Yongkui Lu, MD
Affiliation: Affiliated Cancer Hospital of Guangxi Medical University
Role: PRINCIPAL_INVESTIGATOR
Name: Quchang Ouyang, PhD
Affiliation: Hunan Cancer Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Ying Lin, phD
Affiliation: First Affiliated Hospital, Sun Yat-Sen University
Role: PRINCIPAL_INVESTIGATOR
Name: Ying Zhang, MD
Affiliation: Affiliated Hospital of Guangdong Medical University
Role: PRINCIPAL_INVESTIGATOR
Name: Mei Huang, MD
Affiliation: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Zhiyong Wu, MD
Affiliation: Shantou Central Hospitalv
Role: PRINCIPAL_INVESTIGATOR
Name: Cai'wen Du, PhD
Affiliation: Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
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