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

Actively Recruiting

Phase 3

Age: 18Years - 75Years

FEMALE

NCT04263298

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

Led by Herui Yao · Updated on 2022-09-30

210

Participants Needed

Research Sites

626 weeks

Total Duration

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years

FEMALE

Eligibility Criteria

You may qualify if you...

Female patients aged 18 to 75 years with advanced breast cancer confirmed by pathology, not suitable for surgery or radiation for cure
Hormone receptor positive (ER and/or PR >1% tumor cell staining) and HER2 negative breast cancer
No disease progression after 4 to 8 courses of first-line chemotherapy (complete response, partial response, or stable disease); capecitabine monotherapy allowed up to 6 courses
WHO physical status score of 0 or 1, with an expected lifetime of at least 3 months
Imaging examinations within 3 weeks before enrollment to assess tumor lesions
Previous treatment-related toxicity reduced to Grade 1 or less (except hair loss and non-safety risks)
Normal routine blood test within 1 week before enrollment: WBC ≥3.0×10^9/L, ANC ≥1.5×10^9/L, PLT ≥100×10^9/L
Normal liver and kidney function tests within 1 week before enrollment based on local lab standards
Signed informed consent before enrollment

You will not qualify if you...

Newly developed central nervous system metastases or central nervous system symptom control less than 4 weeks (stable asymptomatic brain metastases >4 weeks allowed without corticosteroids)
Diagnosis of other malignant tumors within 3 years except adequately treated basal or squamous cell skin cancer or cervical cancer in situ
Prior endocrine therapy for advanced disease
Pregnant or breastfeeding women
Serious medical conditions affecting safety, such as uncontrolled heart disease, high blood pressure, infections, or active hepatitis B
Inability to tolerate capecitabine toxicity during first-line treatment
Recurrence of metastatic disease within 2 years after adjuvant endocrine therapy

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