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Everolimus (RAD001) in Combination With Intravenous Carboplatin in Taxane- and Anthracycline-pretreated Patients With Progressive Metastatic Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Everolimus (RAD001) in Combination With Intravenous Carboplatin in Taxane- and Anthracycline-pretreated Patients With Progressive Metastatic Breast Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: dose limiting toxicity

Outcome Time Frame:

after three weeks

Safety Issue:

Yes

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CRAD001JDE15T

NCT ID:

NCT00930475

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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