Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2) (STOP)
18 maj 2017 uppdaterad av: Merck Sharp & Dohme LLC
Temozolomide in Metastatic Breast Cancer Patients at High Risk of Brain Recurrence: Impact on the Incidence of Brain Metastases (STOP)
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning (Faktisk)
6
Fas
- Fas 2
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 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.
- No clinical sign of brain progression.
- At least one of the following 3 conditions: HER2 +++, Young age (< 50 years), and/or estrogen receptor (ER)-/progesterone receptor (PgR)-
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Life expectancy ≥3 months.
- Neutrophils ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9 g/dL, lymphocytes ≥1 x 10^9/L.
- Bilirubin level either normal or <1.5 x ULN (upper limit of normal).
- AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤2.5 x ULN (≤5 x ULN if liver metastases are present).
- Serum creatine <1.5 x ULN.
- Effective contraception if the risk of conception exists.
Exclusion Criteria:
- Concurrent chronic systemic immune therapy not indicated in the study protocol.
- Any investigational agent(s) within 4 weeks prior to entry.
- Participants that have completed 2nd, 3rd, or 4th line metastatic chemotherapy or participant in active chemotherapy treatment.
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months.
- Acute or sub acute intestinal occlusion or history of inflammatory bowel disease.
- Known Grade 3 or Grade 4 allergic reaction to any of the components of the treatment.
- Known drug abuse/alcohol abuse.
- Legal incapacity or limited legal capacity.
- Medical or psychological condition which in the opinion of the investigator would not permit the participant to complete the study or sign meaningful informed consent.
- Women who are pregnant or breastfeeding.
- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (participants with a previous malignancy but without evidence of disease for ≥5 years will be allowed to enter the trial).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Temozolomid
|
Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
|
|
Inget ingripande: Observationell
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percent of Participants With Recurrence of Brain Metastases
Tidsram: 1 Year
|
The analysis could not be performed due to low enrollment.
|
1 Year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Days With Progression-free Survival (PFS)
Tidsram: 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. |
24, 38, and 52 weeks
|
|
Number of Days With Disease-free Survival (DFS)
Tidsram: 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. |
24, 38, and 52 weeks
|
|
Number of Days With Distant Disease-free Survival (DDFS)
Tidsram: 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. |
24, 38, and 52 weeks
|
|
Number of Days With Brain Recurrence-free Survival (BRFS)
Tidsram: 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. |
24,38, and 52 weeks
|
|
Number of Days on Temozolomide Treatment
Tidsram: Baseline to 24 Weeks
|
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
Tidsram: Baseline to 24 Weeks
|
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
Tidsram: Baseline to 24 Weeks
|
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
Tidsram: Baseline to 24 Weeks
|
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
Tidsram: Baseline to 24 Weeks
|
This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.
|
Baseline to 24 Weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
2 oktober 2008
Primärt slutförande (Faktisk)
30 juni 2010
Avslutad studie (Faktisk)
30 juni 2010
Studieregistreringsdatum
Först inskickad
10 januari 2008
Först inskickad som uppfyllde QC-kriterierna
18 mars 2008
Första postat (Uppskatta)
19 mars 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 juni 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 maj 2017
Senast verifierad
1 maj 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Hudsjukdomar
- Neoplasmer efter plats
- Sjukdomsegenskaper
- Bröstsjukdomar
- Neoplasmer i centrala nervsystemet
- Neoplasmer i nervsystemet
- Neoplasmer
- Bröstneoplasmer
- Upprepning
- Neoplasmer i hjärnan
- Neoplasmer, andra primära
- Molekylära mekanismer för farmakologisk verkan
- Antineoplastiska medel
- Antineoplastiska medel, Alkylering
- Alkyleringsmedel
- Temozolomid
Andra studie-ID-nummer
- P05225
- 2007-005491-14 (EudraCT-nummer)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Ja
IPD-planbeskrivning
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
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