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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
Fulvestrant 500mg Days 0, 14, 28, then every 28 days
Capecitabine 2000mg/m2 twice daily x 14 days followed by 7 days off
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGPublic Health Institute of Sun Yat-sen University
Guangzhou, Guangdong, China
Progression free survival (PFS)
From enrollment to progression or death (for any reason)
Time frame: Estimated 18 months
Overall Survival (OS)
From enrollment to death (for any reason)
Time frame: Estimated 60 months
Objective Response Rate (ORR)
Ratio of CR and PR in all subjects
Time frame: Estimated 18 months
Clinical Benefit Rate (CBR)
Ratio of CR,PR and SD greater than or equal to 24 weeks in all subjects
Time frame: Estimated 18 months
Quality Of Life (QOL)
All patients need to fill in the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 44-item self-report instrument designed to measure multidimensional quality of life (QL) in patients with breast cancer.
Time frame: Estimated up to 60 months
Adverse Events and Serious Adverse Events
Safety
Time frame: From informed consent through 28 days following treatment completion
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGShantou Central Hospital
Shantou, Guangdong, China
RECRUITINGCancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, China
RECRUITINGShenzhen People's Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGAffiliated Hospital of Guangdong Medical University
Zhangjiang, Guangdong, China
RECRUITING...and 3 more locations