Trials Sponsors Conditions Drugs Pricing

Conditions

Brain Neoplasm Breast Neoplasm Second Neoplasm

Outcome Measures

Primary Outcomes (1)

Percent of Participants With Recurrence of Brain Metastases
The analysis could not be performed due to low enrollment.
1 Year

Secondary Outcomes (9)

Number of Days With Progression-free Survival (PFS)
24, 38, and 52 weeks
Number of Days With Disease-free Survival (DFS)
24, 38, and 52 weeks
Number of Days With Distant Disease-free Survival (DDFS)
24, 38, and 52 weeks
Number of Days With Brain Recurrence-free Survival (BRFS)
24,38, and 52 weeks
Number of Days on Temozolomide Treatment
Baseline to 24 Weeks
+4 more secondary outcomes

Study Arms (2)

Temozolomide

EXPERIMENTAL

Drug: temozolomide

Observational

NO INTERVENTION

Interventions

temozolomideDrug

Capsules to equal 75 mg/m\^2, orally, daily for 6 weeks, in 3 eight-week cycles

Temozolomide

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of metastatic breast cancer.
Participants must have completed first line of metastatic chemotherapy and have achieved complete or partial response or disease stability for at least 6 months from the first confirmation of disease stabilization.

Sponsors & Collaborators

Merck Sharp & Dohme LLC
Industrylead

MeSH Terms

Conditions

Breast NeoplasmsBrain NeoplasmsNeoplasms, Second Primary

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Limitations and Caveats

The primary outcome measure and the survival analyses could not be analyzed due to the low enrollment.

Results Point of Contact

Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

6 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 10, 2008

First Posted

March 19, 2008

Study Start

October 2, 2008

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Temozolomide

Observational

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Temozolomide

Observational

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record