A Phase II Study of Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Locally Advanced or Primary Metastatic Breast Cancer
Each year, more than 200,000 patients are diagnosed with breast cancer. While recent
advances in diagnosis and treatment have rendered a large proportion of these patients
curable, many patients still present with either locally advanced or metastatic breast
cancer that is not amenable to potentially curative surgery. To enhance the chance of
complete surgical resection of the tumor, patients with very large, locally advanced or
inflammatory breast cancer will be offered neo-adjuvant therapy.
The use of systemic chemotherapy after the surgical therapy for patients with operable
disease has been associated with a 25%-35% reduction in the risk of systemic relapse (Early
Breast Cancer Trialists' Collaborative Group, 1998) Administration of chemotherapy prior to
surgery, also referred to as neoadjuvant chemotherapy is often used in patients with
inoperable, non-metastatic breast cancer. However more recently, neoadjuvant therapy has
become more commonly used as it allows the direct assessment of response to systemic therapy
and the collection of biological markers of therapy that are otherwise difficult to obtain.
Furthermore, the relative high response rate allows the ability to surgically remove the
tumor and achieve adequate tumor-free margins.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic response at definitive surgery
after 4 cycles of theray
Pamela Munster, M.D.
University of California, San Francisco
United States: Food and Drug Administration
|University of California San Francisco||San Francisco, California 941104206|