Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This is an open-label, mono-center phase I/II study designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of RAD001 in combination with carboplatin in taxane- and anthracycline-pretreated patients with progressive metastatic breast cancer. Additionally, the study is designed to characterize the safety, the tolerability and efficacy of this study.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborators: KKS Netzwerk; Novartis Pharmaceuticals
• Treatments: Carboplatin; Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• adult female patients

• at least two prior chemotherapies due to metastatic or inoperable breast cancer

• Karnofsky performance status of at least 60%

• pretreatment with at least one taxane and one anthracycline

Exclusion Criteria:

• previous treatment with mTOR-inhibitors, carboplatin, cisplatin or oxaliplatin

• inadequate organ function including bone marrow function

• bleeding tumours

• known uncontrolled metastases in CNS or carcinomatous meningosis

• patients who have been treated during the last five days with inhibitors or inducers of CYP3A

• serious pulmonary, neurological, endocrinological or other disorders interfering with this study medication, especially patients with known lung fibrosis, emphysema or severe COPD