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

StatusCompleted
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  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 wordsv24 Show all 3 changesShow less
    • Primary endpoints revised (2)
    • Publications expanded, about 68 words

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  3. Primary endpoints: 1 to 2 Completion date: Feb 2013 · Eligibility criteria expanded, about 19 words · Study description revisedv23 Show all 4 changesShow less
    • Completion date: Feb 2013
    • Eligibility criteria expanded, about 19 words
    • Study description revised

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  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 2013v22 Show all 3 changesShow less
    • Enrollment target: estimated 47 to confirmed 40
    • Primary completion date changed from estimate of Apr 2014 to Feb 2013
  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 revisedv17 Show all 3 changesShow less
    • Enrollment target: 40 to 47
    • Study site revised

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  5. Trial status: Recruiting to Active, Not Recruiting Site details revisedv16 Show all 2 changesShow less
    • Site details revised
  6. Primary endpoint revised Study description expanded, about 4 wordsv15 Show all 2 changesShow less
    • Study description expanded, about 4 words

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  7. Re-verified, no change to tracked fieldsv14
  8. Primary completion date: Apr 2009 to Apr 2010 Primary endpoint revised · Secondary endpoints shortened, about 12 words · Study description expanded, about 20 words · 1 morev13 Show all 5 changesShow less
    • Primary endpoint revised
    • Secondary endpoints shortened, about 12 words
    • Study description expanded, about 20 words
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  9. Primary endpoint revised Secondary endpoints: 2 to 1v12 Show all 2 changesShow less
    • Secondary endpoints: 2 to 1

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  10. Eligibility criteria expanded, about 1 word Study title expanded, about 5 wordsv11 Show all 2 changesShow less
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  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 wordsv8 Show all 3 changesShow less
    • Secondary endpoints: 1 to 2
    • Study description shortened, about 37 words

    See this version in full on ClinicalTrials.gov ↗

  13. Primary completion date: Apr 2009 Study description expanded, about 6 words · Study arms: 0 to 1v7 Show all 3 changesShow less
    • Study description expanded, about 6 words
    • Study arms: 0 to 1

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  14. Re-verified, no change to tracked fieldsv6
  15. Site details revised Study title shortened, about 11 wordsv5 Show all 2 changesShow less
    • Study title shortened, about 11 words

    See this version in full on ClinicalTrials.gov ↗

  16. Completion date: Apr 2006 to not stated Eligibility criteria expanded, about 22 words · Study description expanded, about 704 words · Study title shortened, about 1 wordv4 Show all 4 changesShow less
    • Eligibility criteria expanded, about 22 words
    • Study description expanded, about 704 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  17. Eligibility criteria expanded, about 14 wordsv3 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  18. Eligibility criteria shortened, about 12 wordsv2 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 Breast Cancer, Neoplasm Metastasis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov