Clinical trial NCT00921115
Conditions: Invasive Breast Cancer
Keywords: hormone receptor positive invasive breast cancer endocrine therapy Anastrazole Fulvestrant breast tumors postmenopausal
Sponsor: University of Kansas Medical Center
Start date: 2009-05-01; Completion date: 2023-03-20
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done to test the safety and effectiveness of two drugs, Anastrozole and Fulvestrant, used as combined therapy in the neo-adjuvant setting for hormone receptor positive invasive breast cancer.

Detailed description:
Hormonal therapies are generally preferred treatments of breast cancer because they have minimal side effects. Hormone receptor positive breast cancer generally does not respond very well to chemotherapy, which has many side effects. Hormonal therapy with a single drug such as Anastrozole is the main type of treatment used to reduce the risk of cancer recurrence. Whether a combination of Anastrazole nad Fulvestrant is effective and feasible is not known. This study is being done to answer this question.

This is a phase II single arm study. Patients will have an Oncotype Dx performed and only if the recurrence score is low or intermediate, they would be eligible. Eligible patients will receive Anastrazole and Fulvestrant for 16 week.

Subjects will receive Anastrazole 1 mg po q day and Fulvestrant 500 mg IM, day 1, day 14, day 28 and thereafter once every 28 days on outpatient basis. On day 28, subjects will be evaluated for side effects and clinically and a needle core biopsy (optional) will be obtained. If there is increase in Ki 67 by 50%, subjects will be taken off the study. Response evaluation will occur every 28 days during outpatient clinic visits. All treatment will continue until 4 months when patients will undergo surgical intervention. After surgery, patients will be off study and will receive additional breast cancer therapy at the discretion of their treating physician. Patients who develop progressive disease on protocol will be removed from the study and will then be treated at the discretion of the treating physician. The protocol will be closed after the last accrued patient has had surgery.

Arms: arm 1: Patients will have an Oncotype Dx performed and if the RS is \<25, they will receive Anastrazole and Fulvestrant for 16 weeks.

On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.
Interventions: intervention 1: Fulvestrant intervention 2: Anastrazole
Intervention descriptions: intervention 1: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles. intervention 2: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles

Protocol documents: