Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer
Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: RAD001 (Everolimus) in combination with carboplatin Type: Drug
Name: RAD001 (Everolimus) in combination with carboplatin Type: Drug
Overall Status
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
Charité, university medicine, Berlin, CCM
Berlin, Germany
Status: Recruiting
Start Date
February 2009
Charite University, Berlin, Germany
Charite University, Berlin, Germany
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page