Clinical Trial: DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: DETECT IV - A Prospective, Multicenter, Open-label, Phase II Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells

Brief Summary: Several studies have indicated that determining prevalence and number of circulating tumor cells (CTCs) at various time points during treatment may be an effective tool for assessing treatment efficacy in metastatic breast cancer (MBC). However, even if the prognostic value of CTCs in MBC is well understood, the role of both CTC prevalence and CTC phenotype in predicting treatment response needs further investigation. DETECT IV is a prospective, multicenter, open-label, phase II study in patients with HER2-negative metastatic breast cancer and persisting HER2-negative circulating tumor cells (CTCs). Additional research on CTC dynamics and characteristics will provide a better understanding of the prognostic and predictive value of CTCs and is one step into a more personalized therapy for MBC.

Detailed Summary:
Sponsor: Prof. W. Janni

Current Primary Outcome: Progression free survival (PFS) [ Time Frame: 8-12 weeks ]

Time interval from randomization until progressive disease (PD) or death from any cause, whichever comes first


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall response rate [ Time Frame: 8-12 weeks ]
    Rate of complete (CR) and partial responses (PR) in patients with whom target lesions were defined
  • Disease control rate (DCR) [ Time Frame: 8-12 weeks ]
    rate of patients who were assessed as having a PR or a CR or who had stable disease (SD) for at least 6 months
  • Overall survival (OS) [ Time Frame: 4 weeks ]
    Time from randomization until death of any cause
  • Dynamic of CTCs [ Time Frame: 8-12 weeks ]
    Descriptive statistics of regular CTC counts
  • For Everolimus cohort only: Levels of pS6 [ Time Frame: 8-12 weeks ]
    Descriptive statistics of pS6 levels at baseline, at first radiological tumor assessment after about 12 weeks, and at the time of progression
  • For Everolimus cohort only: Change in the activation of the PI3K/Akt/mTOR-pathway in CTCs [ Time Frame: 8-12 weeks ]
    Descriptive statistics of changes in the activation of the PI3K/Akt/mTOR-pathway in CTCs as assessed by longitudinal comparisons (at baseline, after 12 weeks, at time of progression)
  • For Everolimus cohort only: Estrogen-receptor 1 (ESR-1) mutations in CTCs [ Time Frame: 8-12 weeks ]
    Estrogen-receptor 1 (ESR-1) mutations in CTCs at baseline, after 12 weeks and at time of progression
  • For Eribulin cohort only: New metastasis-free survival (nMFS) [ Time Frame: 8-12 weeks ]
    New metastasis-free survival (nMFS), defined as time from recruitment to death or progression due to appearance of a new metastasis, whichever comes first. If a patient has not had an event, nMFS is censored at the date of last adequate tumor as-sessment


Original Secondary Outcome:

  • Overall response rate [ Time Frame: 8-12 weeks ]
    Rate of complete (CR) and partial responses (PR) in patients with whom target lesions were defined
  • Disease control rate (DCR) [ Time Frame: 8-12 weeks ]
    rate of patients who were assessed as having a PR or a CR or who had stable disease (SD) for at least 6 months
  • Overall survival (OS) [ Time Frame: 4 weeks ]
    Time from randomization until death of any cause
  • Dynamic of CTCs [ Time Frame: 8-12 weeks ]
    Descriptive statistics of regular CTC counts
  • Levels of pS6 [ Time Frame: 8-12 weeks ]
    Descriptive statistics of pS6 levels at baseline, at first radiological tumor assessment after about 12 weeks, and at the time of progression
  • Change in the activation of the PI3K/Akt/mTOR-pathway in CTCs [ Time Frame: 8-12 weeks ]
    Descriptive statistics of changes in the activation of the PI3K/Akt/mTOR-pathway in CTCs as assessed by longitudinal comparisons (at baseline, after 12 weeks, at time of progression)
  • Estrogen-receptor 1 (ESR-1) mutations in CTCs [ Time Frame: 8-12 weeks ]
    Estrogen-receptor 1 (ESR-1) mutations in CTCs at baseline, after 12 weeks and at time of progression


Information By: University of Ulm

Dates:
Date Received: January 12, 2014
Date Started: January 2014
Date Completion:
Last Updated: January 7, 2015
Last Verified: January 2015