Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT00930475
Recruitment Status : Unknown
Verified June 2010 by Charite University, Berlin, Germany. Recruitment status was: Recruiting
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.
Condition or disease
Drug: RAD001 (Everolimus) in combination with carboplatin
Phase 1Phase 2
During the phase I part the study will include at least 3 patients at each dose-level until MTD is reached. Each cohort will consist of newly enrolled patients. Intra-patient dose escalation is not permitted. Once MTD is reached a total of 6 patients will be treated at MTD (phase I). For the phase II the minimax two-stage design will be applied. After testing the drug on 16 patients in the first stage of phase II, the trial will be terminated if 1 or fewer respond (SD, PR, CR). If the trial goes on to the second stage, a total of 34 patients will be studied during the phase II part.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
previous treatment with mTOR-inhibitors, carboplatin, cisplatin or oxaliplatin
inadequate organ function including bone marrow function
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