BridgeMD
Compares treatment options for Metastatic Breast Cancer
Official title Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT04263298
What this study is testing
What is Fulvestrant?
Fulvestrant is an investigational medicine, being studied as a potential treatment for metastatic breast cancer.
Also referred to as Experimental group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Adult female patients with advanced breast cancer diagnosed by pathology (aged 18-75, including 18 and 75 years old), not suitable for surgical...
- Pathological examination confirmed ER and / or PR positive, HER-2 negative (Positive ER expression: immunohistochemistry \>1% tumor cell staining...
- Patients with advanced breast cancer who have no disease progression after a 4-8-course first-line chemotherapy regimen (the effect is evaluated as...
- 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...
You likely can't join 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...
- Diagnosis of any other malignant tumor within 3 years before randomization, except for adequately treated basal cells or squamous cell skin cancer or...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- Informed consent form signed before enrollment.
- 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...
- 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...
- 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);
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Shantou, Guangdong, China
- Shenzhen, Guangdong, China
- Zhangjiang, Guangdong, China
- Zhuhai, Guangdong, China
- Nanning, Guangxi, China
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Shantou, Guangdong, China; Shenzhen, Guangdong, China; Zhangjiang, Guangdong, China; Zhuhai, Guangdong, China; Nanning, Guangxi, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.