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Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer

7. november 2011 opdateret af: Wyeth is now a wholly owned subsidiary of Pfizer

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of Oral CCI-779 Administered in Combination With Letrozole vs. Letrozole Alone as First Line Hormonal Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

In this clinical research study, postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and letrozole in first-line hormonal treatment. The primary endpoint of this study is to determine overall progression free survival.

Individual subjects will participate in the active treatment phase of the study until disease progression or withdrawal of consent, provided that test article is being tolerated. All subjects will be asked to participate in the long-term follow-up phase of the study, which includes follow-up every 3 months until disease progression (for subjects who withdraw for reasons other than documented progressive disease) or until any new cancer treatment is received, and for survival. The estimated duration of study participation is 34 months.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

1236

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N4N2
    • British Columbia
      • North Vancouver, British Columbia, Canada, V7L 2L7
      • Richmond, British Columbia, Canada, V6X1A2
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
      • Hamilton, Ontario, Canada, L8V 5C2
      • Newmarket, Ontario, Canada, L3Y 2P9
      • Toronto, Ontario, Canada, M5G 2M9
      • Toronto, Ontario, Canada, M5G 1X5
      • Toronto, Ontario, Canada, M4C-3E7
      • Toronto, Ontario, Canada, M4N 3N5
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
      • Fleurimont, Quebec, Canada, J1H 5N4
      • Levis, Quebec, Canada, G1V3Z1
      • Pointe Claire, Quebec, Canada, H9R4S3
      • Quebec City, Quebec, Canada, G1R2J6
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N4H4
  • Forenede Stater
    • Alabama
      • Hoover, Alabama, Forenede Stater, 35216
      • Huntsville, Alabama, Forenede Stater, 35801
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85715
    • Arkansas
      • Jonesboro, Arkansas, Forenede Stater, 72401
    • California
      • Burbank, California, Forenede Stater, 91505
      • Campbell, California, Forenede Stater, 95008
      • Fountain Valley, California, Forenede Stater, 92708
      • Gilroy, California, Forenede Stater, 95020
      • Glendora, California, Forenede Stater, 91740
      • Modesto, California, Forenede Stater, 95355
      • Montebello, California, Forenede Stater, 90640
      • Pomona, California, Forenede Stater, 91767
      • Poway, California, Forenede Stater, 92064
      • Sacramento, California, Forenede Stater, 95816
      • San Diego, California, Forenede Stater, 92123
      • Santa Rosa, California, Forenede Stater, 95405
      • Soquel, California, Forenede Stater, 95073
      • Vista, California, Forenede Stater, 92083
    • Colorado
      • Lakewood, Colorado, Forenede Stater, 80215
    • Connecticut
      • Norwalk, Connecticut, Forenede Stater, 06851
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33428
      • Fort Lauderdale, Florida, Forenede Stater, 33305
      • Hollywood, Florida, Forenede Stater, 33021
      • Jacksonville, Florida, Forenede Stater, 32209
      • Jacksonville, Florida, Forenede Stater, 32224
      • Lake Worth, Florida, Forenede Stater, 33461
      • Miami Shores, Florida, Forenede Stater, 33138
      • New Port Richey, Florida, Forenede Stater, 34652
      • Plantation, Florida, Forenede Stater, 33324
      • Sarasota, Florida, Forenede Stater, 34239
      • Zephyrhills, Florida, Forenede Stater, 33542
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30309-1710
      • Columbus, Georgia, Forenede Stater, 31902
      • Roswell, Georgia, Forenede Stater, 30076
      • Thomasville, Georgia, Forenede Stater, 31792
    • Idaho
      • Coeur d'Alene, Idaho, Forenede Stater, 83814
    • Illinois
      • Centralia, Illinois, Forenede Stater, 62801
      • Skokie, Illinois, Forenede Stater, 60076
      • Skokie, Illinois, Forenede Stater, 60077
      • Springfield, Illinois, Forenede Stater, 62702
      • Urbana, Illinois, Forenede Stater, 61801
    • Indiana
      • Munster, Indiana, Forenede Stater, 46321
      • South Bend, Indiana, Forenede Stater, 46601
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40504
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
      • Baltimore, Maryland, Forenede Stater, 21237
      • Baltimore, Maryland, Forenede Stater, 21231
      • Bethesda, Maryland, Forenede Stater, 20817
      • Frederick, Maryland, Forenede Stater, 21701
      • Towson, Maryland, Forenede Stater, 21204
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02135
      • Boston, Massachusetts, Forenede Stater, 02118
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
      • Detroit, Michigan, Forenede Stater, 48202
      • Flint, Michigan, Forenede Stater, 48503
      • Grand Rapids, Michigan, Forenede Stater, 49503
      • Grand Rapids, Michigan, Forenede Stater, 49546
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
    • Mississippi
      • Hattiesburg, Mississippi, Forenede Stater, 39401
    • Missouri
      • Rolla, Missouri, Forenede Stater, 65401
    • Montana
      • Great Falls, Montana, Forenede Stater, 59406
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68198
    • Nevada
      • Carson City, Nevada, Forenede Stater, 89703
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
    • New Jersey
      • Belleville, New Jersey, Forenede Stater, 07109
      • Somerset, New Jersey, Forenede Stater, 08873
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87109
    • New York
      • Binghamton, New York, Forenede Stater, 13905
      • East Syracuse, New York, Forenede Stater, 13057
      • New York, New York, Forenede Stater, 10032
      • Nyack, New York, Forenede Stater, 10960
      • Staten Island, New York, Forenede Stater, 10305
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28203
      • Gastonia, North Carolina, Forenede Stater, 28054
      • Wilmington, North Carolina, Forenede Stater, 28401
      • Winston-Salem, North Carolina, Forenede Stater, 27103
    • North Dakota
      • Bismark, North Dakota, Forenede Stater, 58504
    • Ohio
      • Canton, Ohio, Forenede Stater, 44718
      • Canton, Ohio, Forenede Stater, 44710
      • Cincinnati, Ohio, Forenede Stater, 45219
      • Cincinnati, Ohio, Forenede Stater, 45238
      • Cleveland, Ohio, Forenede Stater, 44195
      • Cleveland, Ohio, Forenede Stater, 44106-5055
      • Columbus, Ohio, Forenede Stater, 43215
      • Columbus, Ohio, Forenede Stater, 43235
      • Mayfield Heights, Ohio, Forenede Stater, 44124
    • Oregon
      • Corvallis, Oregon, Forenede Stater, 97330
      • Portland, Oregon, Forenede Stater, 97213
    • Pennsylvania
      • Harrisburg, Pennsylvania, Forenede Stater, 17110
      • Hershey, Pennsylvania, Forenede Stater, 17033
      • Langhorne, Pennsylvania, Forenede Stater, 19047
      • Philadelphia, Pennsylvania, Forenede Stater, 19106
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
      • Columbia, South Carolina, Forenede Stater, 29169
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37404
      • Nashville, Tennessee, Forenede Stater, 37203
      • Nashville, Tennessee, Forenede Stater, 37205
    • Texas
      • Arlington, Texas, Forenede Stater, 76012
      • Corpus Christi, Texas, Forenede Stater, 78412
      • Dallas, Texas, Forenede Stater, 75230
      • Fort Worth, Texas, Forenede Stater, 76104
      • Irving, Texas, Forenede Stater, 75038
      • Tyler, Texas, Forenede Stater, 75701
    • Utah
      • Logan, Utah, Forenede Stater, 84341
      • Ogden, Utah, Forenede Stater, 84403
    • Virginia
      • Arlington, Virginia, Forenede Stater, 22205-3637
      • Richmond, Virginia, Forenede Stater, 23294
      • Woodbridge, Virginia, Forenede Stater, 22191
    • Washington
      • Seattle, Washington, Forenede Stater, 98101
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26505

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

Kvinde

Beskrivelse

Inclusion Criteria:

  • Women aged greater than 18 years.
  • Postmenopausal subjects
  • Confirmed diagnosis of locally advanced (not amenable to curative surgery and/or radiation) or metastatic breast cancer (Stage 3B or 4 respectively, by American Joint Committee on Cancer Criteria)

Exclusion Criteria:

  • Extensive visceral disease
  • Subjects with bone as the only site of disease
  • Prior radiation therapy to the site of measurable disease for subjects with a solitary measurable lesion

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
To determine overall progression free survival.

Sekundære resultatmål

Resultatmål
To determine safety, survival, health outcomes, prognostic markers and pharmacogenomics analysis.

Samarbejdspartnere og efterforskere

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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. maj 2004

Primær færdiggørelse (Faktiske)

1. oktober 2006

Studieafslutning (Faktiske)

1. oktober 2006

Datoer for studieregistrering

Først indsendt

4. juni 2004

Først indsendt, der opfyldte QC-kriterier

7. juni 2004

Først opslået (Skøn)

8. juni 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. november 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. november 2011

Sidst verificeret

1. november 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 3066A1-303

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Brystneoplasmer

Kliniske forsøg med Temsirolimus (CCI-779) for 34 months

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mexico

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner