Trastuzumab and RAD001 in Patients With Human Epidermal Growth Receptor 2 (HER-2) Overexpressing Breast Cancer

StatusCompleted
PhasePhase 1/2
Started

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Record History

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  1. 5 versions Re-verified since Jun 12, 2014, no change to tracked fieldsv25-v29
  2. Results first posted: Jun 12, 2014
    • Primary endpoints revised (2)
    • Publications expanded, about 68 words
    v24
  3. Primary endpoints: 1 to 2
    • Study completion date: Feb 2013
    • Eligibility criteria expanded, about 19 words
    • Study description revised
    v23
  4. Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 47 to confirmed 40
    • Primary completion date changed from estimate of Apr 2014 to Feb 2013
    v22
  5. Primary completion date: Apr 2013 to Apr 2014v21
Show 19 earlier versionsHide 19 earlier versions
  1. Primary completion date: Apr 2012 to Apr 2013v20
  2. Primary completion date: Apr 2011 to Apr 2012v19
  3. Re-verified, no change to tracked fieldsv18
  4. Primary completion date: Apr 2010 to Apr 2011
    • Enrollment target: 40 to 47
    • Study site revised
    v17
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v16
  6. Primary endpoint revised
    • Study description expanded, about 4 words
    v15
  7. Re-verified, no change to tracked fieldsv14
  8. Primary completion date: Apr 2009 to Apr 2010v13 Show 4 more changesShow less
    • Primary endpoint revised
    • Secondary endpoints shortened, about 12 words
    • Study description expanded, about 20 words
    • Eligibility criteria shortened, about 1 word
  9. Primary endpoint revised
    • Secondary endpoints: 2 to 1
    v12
  10. Eligibility criteria expanded, about 1 word
    • Study title expanded, about 5 words
    v11
  11. 2 versions Re-verified since Aug 12, 2008, no change to tracked fieldsv9-v10
  12. Eligibility criteria expanded, about 16 words
    • Secondary endpoints: 1 to 2
    • Study description shortened, about 37 words
    v8
  13. Primary completion date: Apr 2009
    • Study description expanded, about 6 words
    • Study arms: 0 to 1
    v7
  14. Re-verified, no change to tracked fieldsv6
  15. Site details revised
    • Study title shortened, about 11 words
    v5
  16. Study completion date: Apr 2006 to not stated
    • Eligibility criteria expanded, about 22 words
    • Study description expanded, about 704 words
    • Study title shortened, about 1 word
    v4
  17. Eligibility criteria expanded, about 14 wordsv3
  18. Eligibility criteria shortened, about 12 wordsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Primary Objectives: 1. To identify the optimal dose and pharmacokinetics of RAD001 in combination with trastuzumab in a Phase I trial 2. To determine the efficacy of RAD001 plus trastuzumab in HER-2-overexpressing patients with resistance to trastuzumab-based therapy for metastatic breast cancer in a Phase II trial. 1. Trastuzumab resistance will be defined as the development of progressive disease after trastuzumab-based therapy for metastatic breast cancer. Patients who develop metastases while receiving adjuvant or neoadjuvant trastuzumab will be eligible. 2. Efficacy would be measured by the rate of objective response plus stable disease lasting 6 months (complete response (CR) + partial response (PR) + stable disease SD). Secondary objectives: 1. To determine the pharmacokinetics of RAD001 in combination with trastuzumab. In the phase II portion of the study, pharmacokinetic studies will be optional. 2. To determine the nature and degree of toxicity of RAD001 in combination with trastuzumab in this cohort of patients 3. To determine expression levels of total and phosphorylated mTOR and p70S6K-T389-P as well as relevant downstream signaling components (e.g., S6, 4E-BP1) in pre- and post- treatment tumor samples. 4. To correlate biomarker expression with response to therapy.
Trial Details
NCT Number NCT00317720
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: Novartis
Conditions
(from sponsor)		 Breast Cancer, Neoplasm Metastasis
Related terms Breast Neoplasms, Neoplasm Metastasis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov