Combined Fulvestrant and Anastrozole as Neo-adjuvant Endocrine Therapy in Postmenopausal Women With Hormone Receptor Positive Invasive Breast Cancer
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the pathologic complete response (PCR) rate with 4 months of neo-adjuvant combination endocrine therapy (Anastrazole and Fulvestrant).
Duration of study
Qamar Khan, MD
University of Kansas
United States: Food and Drug Administration
|University of Kansas Medical Center||Kansas City, Kansas 66160-7353|