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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00930475

Enrollment

Registered

2009-06-30

Start date

2009-02-28

Completion date

Unknown

Last updated

2011-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

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.

Interventions

DRUGRAD001 (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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Phase I: dose limiting toxicity	after three weeks
Phase II: response rate	every six weeks

Secondary

Measure	Time frame
Phase I: adverse events	after three weeks

Countries

Germany

Contacts

Primary ContactJan Eucker, Dr. med.

jan.eucker@charite.de

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026