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Clinical Trials/EUCTR2008-006055-52-DE
EUCTR2008-006055-52-DE
Active, not recruiting
Phase 1

Everolimus (RAD001) in combination with intravenous carboplatin in taxane- and anthracycline-pretreated patients with progressive metastatic breast cancer - RAD001 and carboplatin in pretreated metastatic breast cancer

Charité - University Hospital of Berlin0 sites58 target enrollmentNovember 17, 2008
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Charité - University Hospital of Berlin
Enrollment
58
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 17, 2008
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Charité - University Hospital of Berlin

Eligibility Criteria

Inclusion Criteria

  • •Adult, female patients (\= 18 years old)
  • •Histologically or cytologically proven breast cancer that is now progressive (metastatic or locally recurrent) and inoperable.
  • •At least two prior chemotherapy regimens due to metastatic or inoperable breast cancer.
  • •Pretreatment with at least one taxane and one anthracycline (separated or combined) in an adjuvant or metastatic setting.
  • •Completion of all prior chemotherapy, immunotherapy, targeted non\-cytotoxic therapy and radiotherapy two weeks prior to first dose on study. Concomitant treatment with bisphosphonates is possible.
  • •Karnofsky performance status of al least 60%
  • •Signed written informed consent according to ICH/EU GCP and national/local regulations
  • •Infertility or acceptable method of contraception (PEARL \- Index \< 1%)
  • •o Completion of one or more of the following criteria:
  • •\- female of non\-childbearing potential: hysterectomy, bilateral oophorectomy, bilateral tube ligation, post\-menopausal \= 2 years

Exclusion Criteria

  • •Known hypersensitivity against everolismus or sirolimus (rapamycin), carboplatin, or lactose.
  • •Previous treatment with cisplatin, carboplatin, or oxaliplatin.
  • •Previous treatment with RAD001 (Everolimus) or other mTOR\-inhibitors
  • •HER2\-positive patients who are candidates for trastuzumab
  • •Known uncontrolled metastases in CNS or Meningeosis carcinomatosa.
  • •Prevalence of a hypercholesterinemia/hypertriglyceridemia (\> CTC grade 3\).
  • •Uncontrolled infection.
  • •Serious cardiac disease (uncontrolled arrhythmias, unstable angina, severe congestive heart failure).
  • •Serious pulmonary, neurological, endocrinological or other disorder interfering with study medication, especially patients with known lung fibrosis, emphysema, or severe COPD.
  • •Bleeding tumor

Outcomes

Primary Outcomes

Not specified

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