Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2) (STOP)
18. mai 2017 oppdatert 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.
Studieoversikt
Status
Avsluttet
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Intervensjonell
Registrering (Faktiske)
6
Fase
- Fase 2
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Temozolomid
|
Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
|
|
Ingen inngripen: Observasjonsmessig
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percent of Participants With Recurrence of Brain Metastases
Tidsramme: 1 Year
|
The analysis could not be performed due to low enrollment.
|
1 Year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Days With Progression-free Survival (PFS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
2. oktober 2008
Primær fullføring (Faktiske)
30. juni 2010
Studiet fullført (Faktiske)
30. juni 2010
Datoer for studieregistrering
Først innsendt
10. januar 2008
Først innsendt som oppfylte QC-kriteriene
18. mars 2008
Først lagt ut (Anslag)
19. mars 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. juni 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. mai 2017
Sist bekreftet
1. mai 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Hudsykdommer
- Neoplasmer etter nettsted
- Sykdomsattributter
- Bryst sykdommer
- Neoplasmer i sentralnervesystemet
- Neoplasmer i nervesystemet
- Neoplasmer
- Brystneoplasmer
- Tilbakefall
- Neoplasmer i hjernen
- Neoplasmer, Second Primær
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Temozolomid
Andre studie-ID-numre
- P05225
- 2007-005491-14 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ja
IPD-planbeskrivelse
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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