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

18. maj 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

6

Fase

  • Fase 2

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Temozolomid
Medicin: temozolomide
Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
Ingen indgriben: Observationel

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Merck Sharp & Dohme LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. oktober 2008

Primær færdiggørelse (Faktiske)

30. juni 2010

Studieafslutning (Faktiske)

30. juni 2010

Datoer for studieregistrering

Først indsendt

10. januar 2008

Først indsendt, der opfyldte QC-kriterier

18. marts 2008

Først opslået (Skøn)

19. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P05225
  • 2007-005491-14 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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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