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RAD001 Shows Potential to Reverse Resistance to Herceptin(R)* in Metastatic Breast Cancer Patients, Leading to Phase III Trial
Date:12/12/2008

a partial response, six patients had stable disease and one patient had progressive disease. Among the nine patients evaluated in the 30 mg weekly treatment arm, three patients had partial responses, five patients had stable disease and one patient had progressive disease. The critical dose- limiting toxicities occurring in the first cycle of treatment included febrile neutropenia, oral mucositis and confusion occurring in the 5 mg daily, 10 mg daily and 30 mg weekly treatment groups, respectively. The most commonly reported grade 3/4 adverse events (greater than or equal to 10%) suspected of being related to study treatment were neutropenia, lymphopenia, stomatitis, leukopenia, alopecia and anemia.

Study details: abstract #406

An open-label, multicenter Phase I trial evaluated daily RAD001 (2.5 mg, 5 mg and 10 mg) and weekly RAD001 (20 mg, 30 mg, 50 mg and 70 mg) in combination with Navelbine (25 mg/m2 IV over 10-15 min on days 1 and 8 every 21 days) and Herceptin (2 mg/kg IV over 30 min). All patients entering the study had progression on, or shortly after, treatment with Herceptin and all had received prior taxane. The median number of prior chemotherapy regimens was 3 (range: 1-5).

Across treatment arms, there was an overall disease control rate of 62%. Thirty-four heavily pretreated patients were evaluated to date (fifteen patients assigned to 5 mg daily, six to 20 mg weekly, and thirteen to 30 mg weekly). Among the fifteen patients in the 5 mg daily treatment arm, one patient had a complete response, two patients had partial responses, nine patients had stable disease and three patients had progressive disease. Among the six patients in the 20 mg weekly treatment arm, one patient had a partial response, three patients had stable disease and two patients had progressive disease. Among the thirteen patients evaluated in the 30 mg weekly treatment arm, two patients had partial responses, nine pati
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SOURCE Novartis Pharmaceuticals Corporation
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