Comparing fulvestrant and capecitabine for maintenance therapy in 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)

This study is testing whether fulvestrant or capecitabine works better as a follow-up treatment for women with hormone receptor-positive, HER2-negative metastatic breast cancer after their first chemotherapy.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 13 sites (Guangzhou, Guangdong and 12 other locations)
• Trial ID: NCT04263298 on ClinicalTrials.gov

What this trial studies

This phase III trial evaluates the effectiveness and safety of fulvestrant versus capecitabine as maintenance therapies following first-line chemotherapy in patients with hormone receptor-positive, HER2-negative metastatic breast cancer. The study aims to determine which treatment better delays disease progression and maintains quality of life after initial chemotherapy. Eligible participants are adult women who have shown no disease progression after their first-line treatment. The trial will provide insights into optimal maintenance strategies for this patient population.

Who should consider this trial

Good fit: Ideal candidates are adult female patients aged 18-75 with HR+/HER2- metastatic breast cancer who have not progressed after first-line chemotherapy.

Not a fit: Patients with HER2-positive breast cancer or those who have experienced disease progression after first-line chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could identify a more effective maintenance therapy that prolongs survival and improves quality of life for patients with metastatic breast cancer.

How similar studies have performed: Other studies have explored maintenance therapies in metastatic breast cancer, but this specific comparison of fulvestrant and capecitabine is novel.

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);

Where this trial is running

Guangzhou, Guangdong and 12 other locations

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (RECRUITING)
• Public Health Institute of Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)
• The First Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangzhou, Guangdong, China (RECRUITING)
• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
• Shantou Central Hospital — Shantou, Guangdong, China (RECRUITING)
• Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center — Shenzhen, Guangdong, China (RECRUITING)
• Shenzhen People's Hospital — Shenzhen, Guangdong, China (NOT_YET_RECRUITING)
• Affiliated Hospital of Guangdong Medical University — Zhangjiang, Guangdong, China (RECRUITING)
• Fifth Subsidiary Sun Yat-sen University Hospital — Zhuhai, Guangdong, China (RECRUITING)
• Affiliated Cancer Hospital of Guangxi Medical University — Nanning, Guangxi, China (RECRUITING)
• Hunan Cancer Hospital — Changsha, Hunan, China (RECRUITING)

Study contacts

• Principal investigator: Shusen Wang, PhD — Sun Yat-sen University
• Study coordinator: Herui Yao, PhD

Conditions: Metastatic Breast Cancer