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

Metastatic Breast Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04263298
• Other study ID #: SYS-C-201801-5010
• Status: Recruiting
• Phase: Phase 3
• Start date: May 1, 2018
• Est. completion date: May 1, 2030

Study information

• Verified date: September 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Herui Yao, PhD
• Phone: +86 13500018020
• Email: yaoherui[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: May 1, 2030
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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);

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Fulvestrant
Fulvestrant 500mg Days 0, 14, 28, then every 28 days
• Capecitabine Oral Product
Capecitabine 2000mg/m2 twice daily x 14 days followed by 7 days off

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan
China	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	Affiliated Cancer Hospital of Guangxi Medical University	Nanning	Guangxi
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

Sponsors (1)

Lead Sponsor	Collaborator
Herui Yao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	From enrollment to progression or death (for any reason)	Estimated 18 months
Secondary	Overall Survival (OS)	From enrollment to death (for any reason)	Estimated 60 months
Secondary	Objective Response Rate (ORR)	Ratio of CR and PR in all subjects	Estimated 18 months
Secondary	Clinical Benefit Rate (CBR)	Ratio of CR,PR and SD greater than or equal to 24 weeks in all subjects	Estimated 18 months
Secondary	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.	Estimated up to 60 months
Secondary	Adverse Events and Serious Adverse Events	Safety	From informed consent through 28 days following treatment completion