Working… Menu

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

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: RAD001 (Everolimus) in combination with carboplatin Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Everolimus (RAD001) in Combination With Intravenous Carboplatin in Taxane- and Anthracycline-pretreated Patients With Progressive Metastatic Breast Cancer
Study Start Date : February 2009
Estimated Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • 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

Primary Outcome Measures :
  1. Phase I: dose limiting toxicity [ Time Frame: after three weeks ]
  2. Phase II: response rate [ Time Frame: every six weeks ]

Secondary Outcome Measures :
  1. Phase I: adverse events [ Time Frame: after three weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00930475

Layout table for location contacts
Contact: Jan Eucker, Dr. med.

Layout table for location information
Charité, university medicine, Berlin, CCM Recruiting
Berlin, Germany, 10177
Principal Investigator: Jan Eucker, Dr. med.         
Sponsors and Collaborators
Charite University, Berlin, Germany
KKS Netzwerk
Novartis Pharmaceuticals

Layout table for additonal information
Responsible Party: Dr. Jan Eucker, Charite University medicine, Berlin, Germany Identifier: NCT00930475     History of Changes
Other Study ID Numbers: CRAD001JDE15T
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: January 26, 2011
Last Verified: June 2010
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents