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NCT00638963: STOP

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

Terminated Phase 2 Results posted Last updated 14 June 2017
What this trial tests

Phase 2 trial testing temozolomide in Breast Neoplasm in 6 participants. Terminated before completion.

Timeline
2 October 2008
Primary endpoint
30 June 2010
30 June 2010

Quick facts

Lead sponsorMerck Sharp & Dohme LLC
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment6
Start date2 October 2008
Primary completion30 June 2010
Estimated completion30 June 2010

Drugs / interventions tested

Conditions studied

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Breast Neoplasm or Brain Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Days on Temozolomide Treatment Secondary · Baseline to 24 Weeks

This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

GroupValue95% CI
Temozolomide751 – 127
Total Dose of Temozolomide Taken Secondary · Baseline to 24 Weeks

This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

GroupValue95% CI
Temozolomide9791.9± 8732.0
Number of Participants Who Had at Least One Dose Reduction During Treatment Secondary · Baseline to 24 Weeks

This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

GroupValue95% CI
Temozolomide3
Number of Participants Who Had at Least One Treatment Omission During Treatment Secondary · Baseline to 24 Weeks

This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

GroupValue95% CI
Temozolomide2
Number of Participants Who Completed the Third Cycle of Treatment Secondary · Baseline to 24 Weeks

This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.

GroupValue95% CI
Temozolomide2

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Temozolomide
Serious: 0/3 (0%)
Deaths: —
Observational
Serious: 0/3 (0%)
Deaths: —
Other adverse events (11 terms — click to expand)

ReactionSystemTemozolomideObservational
NauseaGastrointestinal disorders——
DiarrhoeaGastrointestinal disorders——
VomitingGastrointestinal disorders——
AstheniaGeneral disorders——
Chest painGeneral disorders——
Influenza like illnessGeneral disorders——
PyrexiaGeneral disorders——
MyalgiaMusculoskeletal and connective tissue disorders——
InsomniaPsychiatric disorders——
Vulvovaginal drynessReproductive system and breast disorders——
ErythemaSkin and subcutaneous tissue disorders——

Data from ClinicalTrials.gov NCT00638963 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Unsanctifying the sanctuary: challenges and opportunities with brain metastases.
    Puhalla S, Elmquist W, Freyer D, Kleinberg L, et al · · 2015 · cited 46× · PMID 25846288 · DOI 10.1093/neuonc/nov023
  2. Emerging treatment options for the management of brain metastases in patients with HER2-positive metastatic breast cancer.
    Chien AJ, Rugo HS. · · 2013 · cited 21× · PMID 23143215 · DOI 10.1007/s10549-012-2328-6
  3. Preventive strategies against brain metastases: current state of the art and future directions.
    Ippen FM, Konen FF, Hau P, Winkler F. · · 2026 · PMID 41928334 · DOI 10.1186/s42466-026-00467-7

Verify or expand the search:

Other trials of temozolomide

Trials testing the same drug.

Other recruiting trials for Breast Neoplasm

Currently open trials in the same condition.

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00638963.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing