Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer

NCT ID: NCT04263298

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2030-05-01

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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fulvestrant Group

Fulvestrant 500mg Days 0, 14, 28, then every 28 days

Group Type: EXPERIMENTAL

Fulvestrant

Intervention Type: DRUG

Fulvestrant 500mg Days 0, 14, 28, then every 28 days

Capecitabine Group

Capecitabine 2000mg/m2 twice daily x 14 days followed by 7 days off

Group Type: ACTIVE_COMPARATOR

Capecitabine Oral Product

Intervention Type: DRUG

Capecitabine 2000mg/m2 twice daily x 14 days followed by 7 days off

Interventions

Fulvestrant

Fulvestrant 500mg Days 0, 14, 28, then every 28 days

Intervention Type: DRUG

Capecitabine Oral Product

Capecitabine 2000mg/m2 twice daily x 14 days followed by 7 days off

Intervention Type: DRUG

Other Intervention Names

Experimental group; Active Comparator control group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

Cannot be grouped if any of the following is true:

• Newly developed central nervous system metastasis or symptom control of central nervous system is less than 4 weeks. (Patients with asymptomatic brian metastases which was stable more than 4 weeks by imaging assessment and do not need corticosteroid therapy are allowed to enrollment)
• Diagnosis of any other malignant tumor within 3 years before randomization, except for adequately treated basal cells or squamous cell skin cancer or cervical cancer in situ;
• Endocrine therapy for advanced disease;
• Pregnant or breast-feeding patients;
• Patients with accompanying disease or situation that may interfere with the study, or any serious medical problems that may affect the safety of the subject (for example, uncontrolled heart disease or high blood pressure, active or uncontrolled infection, active hepatitis B virus infection);
• Patients who were unable to tolerate capecitabine toxicity were first identified in first-line treatment;
• Patients with recurrent metastatic disease within 2 years of adjuvant endocrine therapy (including 2 years);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Herui Yao

OTHER

Sponsor Role: lead

Responsible Party

Herui Yao

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Herui Yao, PhD

Role: STUDY_CHAIR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Shusen Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Kun Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Peijian Peng, PhD

Role: PRINCIPAL_INVESTIGATOR

Fifth Subsidiary Sun Yat-sen University Hospital

Li Ling, PhD

Role: PRINCIPAL_INVESTIGATOR

Public Health Institute of Sun Yat-sen University

Yongkui Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Affiliated Cancer Hospital of Guangxi Medical University

Quchang Ouyang, PhD

Role: PRINCIPAL_INVESTIGATOR

Hunan Cancer Hospital

Ying Lin, phD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Ying Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Guangdong Medical University

Mei Huang, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Zhiyong Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Shantou Central Hospitalv

Cai'wen Du, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Public Health Institute of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Site Status: RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Shantou Central Hospital

Shantou, Guangdong, China

Site Status: RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, China

Site Status: RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Site Status: NOT_YET_RECRUITING

Affiliated Hospital of Guangdong Medical University

Zhangjiang, Guangdong, China

Site Status: RECRUITING

Fifth Subsidiary Sun Yat-sen University Hospital

Zhuhai, Guangdong, China

Site Status: RECRUITING

Affiliated Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status: RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Herui Yao, PhD

Role: CONTACT

yaoherui@mail.sysu.edu.cn

+86 13500018020

Wenjing Wu, PhD

Role: CONTACT

wuwenjing@mail.sysu.edu.cn

+86 15902045077

Facility Contacts

Kun Wang, PhD

Role: primary

Li Ling, PhD

Role: primary

Herui Yao, PhD

Role: primary

yaoherui@mail.sysu.edu.cn

+86 13500018020

Shusen Wang, PhD

Role: primary

Mei Huang, MD

Role: primary

Ying Lin, PhD

Role: primary

Zhiyong Wu, MD

Role: primary

Caiwen Du, PhD

Role: primary

Ruilian Xu, Master

Role: primary

Ying Zhang, MD

Role: primary

Peijian Peng, PhD

Role: primary

Yongkui Lu, MD

Role: primary

Quchang Ouyang, PhD

Role: primary

Other Identifiers

SYS-C-201801-5010

Identifier Type: -

Identifier Source: org_study_id