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)

Who is this study for? Patients with Metastatic Breast Cancer
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Adult female patients with advanced breast cancer diagnosed by pathology (aged 18-75, including 18 and 75 years old), not suitable for surgical resection or radiation therapy for the purpose of cure;

• Pathological examination confirmed ER and / or PR positive, HER-2 negative (Positive ER expression: immunohistochemistry \>1% tumor cell staining; Positive PR expression: immunohistochemistry \>1% tumor cell staining; HER-2 negative: immunohistochemistry is 0,1+, or FISH/CISH negative when immunohistochemistry is 2+);

• Patients with advanced breast cancer who have no disease progression after a 4-8-course first-line chemotherapy regimen (the effect is evaluated as complete response/ partial response/ stable disease). Capecitabine monotherapy as first-line chemotherapy is allowed and the courses of treatment should be limited to 6.

• WHO physical status 0-1 points, estimated lifetime at least 3 months;

• Imaging examinations within 3 weeks before enrollment were required for assessing tumor lesions before maintenance treatment (Examination results from local Tertiary A hospital are available);

• Previous treatment-related toxicity should be relieved to ≤ Grade 1 according to NCI CTCAE (version 4.03) before randomization (Except for hair loss and other toxicities that are not at risk to the patient's safety based on the investigator's judgment);

• The routine blood test was normal within 1 week before enrollment: WBC ≥3.0×10\^9/L, b. ANC ≥1.5×10\^9/L, c. PLT ≥100×10\^9/L;

• The liver and kidney function test was normal within 1 week before enrollment (Take the normal value of the laboratory of each research center as the standard): a. TBIL≤1.5× Upper Limit of Normal (ULN)b. ALT/AST≤2.5×ULN(Liver metastasis patients ≤5xULN) c. Serum Cr ≤1.5×ULN, or Ccr ≥60 ml/min;

• Informed consent form signed before enrollment.

Locations
Other Locations
China
Hunan Cancer Hospital
RECRUITING
Changsha
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Public Health Institute of Sun Yat-sen University
RECRUITING
Guangzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
RECRUITING
Guangzhou
The First Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Affiliated Cancer Hospital of Guangxi Medical University
RECRUITING
Nanning
Shantou Central Hospital
RECRUITING
Shantou
Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center
RECRUITING
Shenzhen
Shenzhen People's Hospital
NOT_YET_RECRUITING
Shenzhen
Affiliated Hospital of Guangdong Medical University
RECRUITING
Zhangjiang
Fifth Subsidiary Sun Yat-sen University Hospital
RECRUITING
Zhuhai
Contact Information
Primary
Herui Yao, PhD
yaoherui@mail.sysu.edu.cn
+86 13500018020
Backup
Wenjing Wu, PhD
wuwenjing@mail.sysu.edu.cn
+86 15902045077
Time Frame
Start Date: 2018-05-01
Estimated Completion Date: 2030-05-01
Participants
Target number of participants: 210
Treatments
Experimental: Fulvestrant Group
Fulvestrant 500mg Days 0, 14, 28, then every 28 days
Active_comparator: Capecitabine Group
Capecitabine 2000mg/m2 twice daily x 14 days followed by 7 days off
Related Therapeutic Areas
Sponsors
Leads: Herui Yao

This content was sourced from clinicaltrials.gov