Efficacy and Safety of 500mg of Fulvestrant

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Dec 22, 2007

Keywords

ClinConnect Summary

This clinical trial is studying a higher dose of a medication called Fulvestrant, which is used to treat women with hormone receptor positive metastatic breast cancer. The goal is to see if this increased dose can lead to better outcomes for patients compared to the lower doses used in previous studies. The trial is currently active but not recruiting new participants.

To be eligible for this study, participants must be women aged 18 or older who have been diagnosed with a specific type of breast cancer that has spread and is not curable. They should also have hormone-sensitive tumors and be postmenopausal. Participants can expect regular check-ups and assessments to monitor their health while receiving the treatment. It’s important to note that there are certain criteria that could exclude someone from joining, such as having life-threatening metastatic disease or recent treatments that might interfere with the trial. Overall, this study aims to explore the potential benefits of Fulvestrant at a higher dose to improve treatment options for women with this type of breast cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female
• • 18 years of age or older
• • Histologically confirmed adenocarcinoma of the breast progressing local-regional or metastatic disease that is not considered amenable to curative treatment
• • Evidence of hormone sensitivity of primary or secondary tumor tissue
• • Postmenopausal as defined by criteria listed in protocol
• • May have had adjuvant endocrine therapy if discontinued at least 12 months prior to inclusion. Subjects who have had minimal exposure to adjuvant or first line metastatic endocrine treatment during the 12 months prior to study enrollment can be eligible with overall PI and sponsor permission
• • Prior trastuzumab and biologic therapy is allowed, but must be discontinued more than 2 weeks prior to inclusion
• • Presence of measurable or evaluable, nonmeasurable, disease. Any x-rays and scans for assessment of measurable disease must be performed with 28 days prior to registration
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
• Exclusion Criteria:
• • Presence of life-threatening metastatic disease
• • Endocrine therapy the advanced disease setting
• • Systemic chemotherapy, whether as adjuvant therapy or for advanced disease, within previous 4 weeks
• • Trastuzumab or biologic therapy within previous 2 weeks
• • Extensive radiation therapy within the last 2 weeks
• • Prior adjuvant or neoadjuvant treatment with fulvestrant is not allowed
• • Concomitant anticancer treatments
• • Chronic bisphosphonates for hypercalcemia or prevention of bone metastases
• • Subjects receiving long-term anticoagulant therapy with warfarin
• • Estrogen replacement therapy within 6 months of trial entry
• • Previous or current systems malignancy within the past 3 years
• • Treatment with non approved or investigational drug within 2 weeks before study entry
• • Any evidence of severe or uncontrolled systemic disease
• • History of bleeding diathesis
• • Any severe concomitant condition which makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the study protocol