Efficacy and Safety of 500mg of Fulvestrant

Beth Israel Lahey Health

Status and phase

Active, not recruiting

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Fulvestrant

Study type

Interventional

Funder types

Other

Identifiers

NCT00585507

04-016

Details and patient eligibility

About

Fulvestrant has proven effective in the treatment of hormone receptor positive metastatic breast cancer. The dose used in studies so far has been well tolerated and may be too low for optimal effectiveness. In this study, a higher dose will be used to see whether an improved outcome will result.

Full description

Fulvestrant will be administered by intramuscular injection on day 1, day 15 and day 29 and then every 28 days thereafter.
Participants will have a physical examination and blood work performed on each treatment date. After teh study treatment has been completed, the physical examinations will be done every three months for the first 2 years, every 6 months for years 2-5, and annually after 5 years.
Participants may remain on study treatment until disease progression or until they experience serious side effects.

Enrollment

40 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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