Clinical trial NCT01010854
Conditions: Breast Cancer
Keywords: breast cancer advanced local
Sponsor: University of California, San Francisco
Start date: 2008-12-10; Completion date: 2011-07-29
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The drugs FEC 100 (5-fluorouracil, epirubicin, and cyclophosphamide) are one of the approved options to treat Locally Advanced or Primary Metastatic Breast Cancer. In this study, the investigators will add another drug called Valproic Acid (VPA) to see whether this makes the treatment better. The addition of Valproic Acid to chemotherapy has been studied in about 65 subjects with cancer and was found to be safe and tolerable. Valproic Acid is approved by the Food and Drug Administration (FDA) for the treatment of seizures, mood swings, and migraine headaches. It is not currently approved for cancer, which is why the investigators are conducting this study.

The results of a Phase I study of Valproic Acid and FEC100 in subjects with cancer that has spread has led the investigators to believe that this combination is better than just the standard treatment alone. The investigators are now testing the combination in a study with subjects who have either a large tumor, many lymph nodes involved or patients whose tumor has spread. In addition to the treatment, a main goal of the study is to find out which subjects will benefit from this combination. In the Phase I trial the investigators noticed that while this combination appears to make the chemotherapy more effective, it did not appear to cause more side effects induced by the chemotherapy.

Detailed description:
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.

Arms: arm 1: Valproic Acid with FEC100
Interventions: intervention 1: VPA FEC100
Intervention descriptions: intervention 1: oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)

Protocol documents: