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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005491-14 | EudraCT Number |
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Terminated due to poor accrual
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temozolomide | Experimental |
| |
| Observational | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temozolomide | Drug | Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With Recurrence of Brain Metastases | The analysis could not be performed due to low enrollment. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days With Progression-free Survival (PFS) | 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. | 24, 38, and 52 weeks |
| Number of Days With Disease-free Survival (DFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Temozolomide | Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles |
| FG001 | Observational | No temozolomide treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Temozolomide | Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles |
| BG001 | Observational | No temozolomide treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Participants With Recurrence of Brain Metastases | The analysis could not be performed due to low enrollment. | Posted | 1 Year |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Temozolomide | Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
The primary outcome measure and the survival analyses could not be analyzed due to the low enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001932 | Brain Neoplasms |
| D016609 | Neoplasms, Second Primary |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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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. |
| 24, 38, and 52 weeks |
| Number of Days With Distant Disease-free Survival (DDFS) | 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. | 24, 38, and 52 weeks |
| Number of Days With Brain Recurrence-free Survival (BRFS) | 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. | 24,38, and 52 weeks |
| Number of Days on Temozolomide Treatment | This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed. | Baseline to 24 Weeks |
| Total Dose of Temozolomide Taken | This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed. | Baseline to 24 Weeks |
| Number of Participants Who Had at Least One Dose Reduction During Treatment | This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed. | Baseline to 24 Weeks |
| Number of Participants Who Had at Least One Treatment Omission During Treatment | This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed. | Baseline to 24 Weeks |
| Number of Participants Who Completed the Third Cycle of Treatment | This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed. | Baseline to 24 Weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Number of Days With Progression-free Survival (PFS) | 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. | Posted | 24, 38, and 52 weeks |
|
|
| Secondary | Number of Days With Disease-free Survival (DFS) | 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. | Posted | 24, 38, and 52 weeks |
|
|
| Secondary | Number of Days With Distant Disease-free Survival (DDFS) | 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. | Posted | 24, 38, and 52 weeks |
|
|
| Secondary | Number of Days With Brain Recurrence-free Survival (BRFS) | 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. | Posted | 24,38, and 52 weeks |
|
|
| Secondary | Number of Days on Temozolomide Treatment | This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed. | Posted | Mean | Standard Deviation | Days | Baseline to 24 Weeks |
|
|
|
| Secondary | Total Dose of Temozolomide Taken | This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed. | Posted | Mean | Standard Deviation | Milligrams | Baseline to 24 Weeks |
|
|
|
| Secondary | Number of Participants Who Had at Least One Dose Reduction During Treatment | This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed. | Posted | Number | Participants | Baseline to 24 Weeks |
|
|
|
| Secondary | Number of Participants Who Had at Least One Treatment Omission During Treatment | This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed. | Posted | Number | Participants | Baseline to 24 Weeks |
|
|
|
| Secondary | Number of Participants Who Completed the Third Cycle of Treatment | This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed. | Posted | Number | Participants | Baseline to 24 Weeks |
|
|
|
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | Observational | No temozolomide treatment | 0 | 3 | 2 | 3 |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
The principal investigator (PI) agrees not to publish or publicly present any interim results of the Study without prior written consent of the sponsor. The PI further agrees to provide 45 days written notice to the sponsor prior to submission for publication or presentation to permit the sponsor to review copies of abstracts or manuscripts for publication in accordance with provisions of laws related to protection of sensitive personal data and patentability of inventions.
| D017437 |
| Skin and Connective Tissue Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |