Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00930475
Recruitment Status : Unknown
Verified June 2010 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : June 30, 2009
Last Update Posted : January 26, 2011
KKS Netzwerk
Novartis Pharmaceuticals
Information provided by:
Charite University, Berlin, Germany

June 18, 2009
June 30, 2009
January 26, 2011
February 2009
December 2010   (Final data collection date for primary outcome measure)
  • Phase I: dose limiting toxicity [ Time Frame: after three weeks ]
  • Phase II: response rate [ Time Frame: every six weeks ]
Same as current
Complete list of historical versions of study NCT00930475 on Archive Site
Phase I: adverse events [ Time Frame: after three weeks ]
Same as current
Not Provided
Not Provided
Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer
Everolimus (RAD001) in Combination With Intravenous Carboplatin in Taxane- and Anthracycline-pretreated Patients With Progressive Metastatic Breast Cancer
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.
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.
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: RAD001 (Everolimus) in combination with carboplatin
    phase I: dose levels: 2,5 mg, 5 mg, 7,5 mg and 10mg daily in combination with carboplatin AUC2 weekly until progress
  • Drug: RAD001 (Everolimus) in combination with carboplatin
    phase 2: 10mg RAD001 in combination with carboplatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Dr. Jan Eucker, Charite University medicine, Berlin, Germany
Charite University, Berlin, Germany
  • KKS Netzwerk
  • Novartis Pharmaceuticals
Not Provided
Charite University, Berlin, Germany
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP