Clinical Trial: Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Temozolomide in Metastatic Breast Cancer Patients at High Risk of Brain Recurrence: Impact on the Incidence of Brain Metastases (STOP)

Brief Summary: The purpose of this study is to determine whether temozolomide can be used as a prophylaxis against brain recurrence in participants with metastatic breast cancer.

Detailed Summary: Breast cancer is the second most common cause of brain metastases. Overall survival after the development of brain metastases tends to be poor (6-8 months). Over-expression of Human Epidermal Growth Factor Receptor 2 (HER-2/neu), negative estrogen receptor, and young age at diagnosis seem to be indicators of high risk for brain metastases. Temozolomide may be a good candidate for prophylactic chemotherapy because of its ability to cross the blood-brain-barrier, achieving high concentrations in the central nervous system (CNS).
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Percent of Participants With Recurrence of Brain Metastases [ Time Frame: 1 Year ]

Original Primary Outcome: Brain recurrence, measured with cranial CT scan [ Time Frame: 1 Year ]

Current Secondary Outcome:

• Number of Days With Progression-free Survival (PFS) [ Time Frame: 24, 38, and 52 weeks ]

  PFS was defined as the time interval from randomization to objective tumor progression or death from any cause.

  The analysis could not be performed due to low enrollment.

• Number of Days With Disease-free Survival (DFS) [ Time Frame: 24, 38, and 52 weeks ]

  DFS was defined as the time interval from randomization to any relapse (loco-regional, contra-lateral, and/or distant).

  The analysis could not be performed due to low enrollment.

• Number of Days With Distant Disease-free Survival (DDFS) [ Time Frame: 24, 38, and 52 weeks ]

  DDFS was defined as the time interval from randomization to only distant metastases (for example, bone, visceral organ, brain).

  The analysis could not be performed due to low enrollment.

• Number of Days With Brain Recurrence-free Survival (BRFS) [ Time Frame: 24,38, and 52 weeks ]

  BRFS was defined as the time interval from randomization to the appearance of brain metastases.

  The analysis could not be performed due to low enrollment.

• Number of Days on Temozolomide Treatment [ Time Frame: Baseline to 24 Weeks ]
  This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
• Total Dose of Temozolomide Taken [ Time Frame: Baseline to 24 Weeks ]
  This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
• Number of Participants Who Had at Least One Dose Reduction During Treatment [ Time Frame: Baseline to 24 Weeks ]
  This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
• Number of Participants Who Had at Least One Treatment Omission During Treatment [ Time Frame: Baseline to 24 Weeks ]
  This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
• Number of Participants Who Completed the Third Cycle of Treatment [ Time Frame: Baseline to 24 Weeks ]
  This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

Original Secondary Outcome: Progression free survival Disease free survival Distant disease free survival Brain recurrence free survival [ Time Frame: 6, 9, and 12 months ]

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: January 10, 2008
Date Started: October 2008
Date Completion:
Last Updated: January 19, 2015
Last Verified: January 2015