NCT04263298|RecruitingPhase 3DMC

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

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)

Herui Yao ClinicalTrials.gov

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1 other identifier

SYS-C-201801-5010

Study Type

interventional

Target

210

Locations

1 country

Sites

Timeline

RegisteredFeb 2020

StartedMay 2018

CompletionMay 2030

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

210

participants targeted

Target at P25-P50 for phase_3

Timeline

48mo left

Started May 2018

Longer than P75 for phase_3

Geographic Reach

1 country

13 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12 years study duration

Study Progress67%

May 2018May 2030

Study Start

First participant enrolled

May 1, 2018

Completed

1.8 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2020

Completed

6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed

5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed

5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Expected

Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

7 years

First QC Date

February 4, 2020

Last Update Submit

September 28, 2022

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

Progression free survival (PFS)
From enrollment to progression or death (for any reason)
Estimated 18 months

Secondary Outcomes (5)

Overall Survival (OS)
Estimated 60 months
Objective Response Rate (ORR)
Estimated 18 months
Clinical Benefit Rate (CBR)
Estimated 18 months
Quality Of Life (QOL)
Estimated up to 60 months
Adverse Events and Serious Adverse Events
From informed consent through 28 days following treatment completion

Study Arms (2)

Fulvestrant Group

EXPERIMENTAL

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

Drug: Fulvestrant

Capecitabine Group

ACTIVE COMPARATOR

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

Drug: Capecitabine Oral Product

Interventions

FulvestrantDRUG

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

Also known as: Experimental group

Fulvestrant Group

Capecitabine Oral ProductDRUG

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

Also known as: Active Comparator control group

Capecitabine Group

Eligibility Criteria

Age18 Years - 75 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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);

Contact the study team to confirm eligibility.