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Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer

2 juli 2012 bijgewerkt door: Pfizer

A Randomized Phase 2 Study Of SU011248 Versus Standard-Of-Care For Patients With Previously Treated, Advanced, Triple Receptor Negative (ER, PR, HER2) Breast Cancer

The purpose of this study is to compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

217

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Bulgarije
      • Sofia, Bulgarije, 1233
        • Pfizer Investigational Site
      • Sofia, Bulgarije, 1527
        • Pfizer Investigational Site
      • Sofia, Bulgarije, 1756
        • Pfizer Investigational Site
      • Stara Zagora, Bulgarije, 6000
        • Pfizer Investigational Site
      • Varna, Bulgarije, 9000
        • Pfizer Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Pfizer Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Pfizer Investigational Site
  • Duitsland
      • Berlin, Duitsland, 10177
        • Pfizer Investigational Site
  • Frankrijk
      • BESANCON Cedex 5, Frankrijk, 25052
        • Pfizer Investigational Site
      • BESANCON cedex, Frankrijk, 25030
        • Pfizer Investigational Site
      • NANTES cedex, Frankrijk, 44805
        • Pfizer Investigational Site
      • Paris Cedex 20, Frankrijk, 75970
        • Pfizer Investigational Site
  • Hongarije
      • Budapest, Hongarije, 1082
        • Pfizer Investigational Site
      • Budapest, Hongarije, 1122
        • Pfizer Investigational Site
  • Italië
      • Aviano (PN), Italië, 33081
        • Pfizer Investigational Site
      • Milano, Italië, 20100
        • Pfizer Investigational Site
      • Prato, FI, Italië, 59100
        • Pfizer Investigational Site
  • Kalkoen
    • Balcali
      • Adana, Balcali, Kalkoen, 01330
        • Pfizer Investigational Site
    • Besevler
      • Ankara, Besevler, Kalkoen, 06510
        • Pfizer Investigational Site
    • Pendik
      • Istanbul, Pendik, Kalkoen, 34890
        • Pfizer Investigational Site
    • Sihhiye
      • Ankara, Sihhiye, Kalkoen, 06100
        • Pfizer Investigational Site
  • Oekraïne
      • Dnipropetrovsk, Oekraïne, 49102
        • Pfizer Investigational Site
      • Kyiv, Oekraïne, 03115
        • Pfizer Investigational Site
      • Odessa, Oekraïne, 65055
        • Pfizer Investigational Site
  • Spanje
      • Barcelona, Spanje, 08035
        • Pfizer Investigational Site
      • Gerona, Spanje, 17007
        • Pfizer Investigational Site
      • Lleida, Spanje, 25198
        • Pfizer Investigational Site
      • Malaga, Spanje, 29010
        • Pfizer Investigational Site
      • Sevilla, Spanje, 41013
        • Pfizer Investigational Site
  • Tsjechische Republiek
      • Brno, Tsjechische Republiek, 656 91
        • Pfizer Investigational Site
      • Praha 8, Tsjechische Republiek, 180 00
        • Pfizer Investigational Site
    • Ceska Republika
      • Brno, Ceska Republika, Tsjechische Republiek, 656 91
        • Pfizer Investigational Site
      • Praha 8, Ceska Republika, Tsjechische Republiek, 180 81
        • Pfizer Investigational Site
  • Verenigd Koninkrijk
      • Edinburgh, Verenigd Koninkrijk, EH4 2XU
        • Pfizer Investigational Site
      • Oxfordshire, Verenigd Koninkrijk, OX3 7LJ
        • Pfizer Investigational Site
      • Southampton, Verenigd Koninkrijk, SO16 6YD
        • Pfizer Investigational Site
  • Verenigde Staten
    • California
      • Corona, California, Verenigde Staten, 92879
        • Pfizer Investigational Site
      • Fullerton, California, Verenigde Staten, 92835
        • Pfizer Investigational Site
      • Glendora, California, Verenigde Staten, 91741
        • Pfizer Investigational Site
      • Los Angeles, California, Verenigde Staten, 90095-1772
        • Pfizer Investigational Site
      • Los Angeles, California, Verenigde Staten, 90095-7423
        • Pfizer Investigational Site
      • Los Angeles, California, Verenigde Staten, 90095
        • Pfizer Investigational Site
      • Mission Hills, California, Verenigde Staten, 91345
        • Pfizer Investigational Site
      • Northridge, California, Verenigde Staten, 91325
        • Pfizer Investigational Site
      • Palm Springs, California, Verenigde Staten, 92262-4885
        • Pfizer Investigational Site
      • Pasadena, California, Verenigde Staten, 91105
        • Pfizer Investigational Site
      • Pomona, California, Verenigde Staten, 91767
        • Pfizer Investigational Site
      • Rancho Cucamonga, California, Verenigde Staten, 91730
        • Pfizer Investigational Site
      • Santa Monica, California, Verenigde Staten, 90404
        • Pfizer Investigational Site
      • Valencia, California, Verenigde Staten, 91355
        • Pfizer Investigational Site
      • West Covina, California, Verenigde Staten, 91790
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80010
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Verenigde Staten, 20010
        • Pfizer Investigational Site
    • Florida
      • Boca Raton, Florida, Verenigde Staten, 33428
        • Pfizer Investigational Site
      • Gainesville, Florida, Verenigde Staten, 32605-4391
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30341
        • Pfizer Investigational Site
      • Atlanta, Georgia, Verenigde Staten, 30342
        • Pfizer Investigational Site
      • Decatur, Georgia, Verenigde Staten, 30033
        • Pfizer Investigational Site
      • Macon, Georgia, Verenigde Staten, 31217
        • Pfizer Investigational Site
      • Marietta, Georgia, Verenigde Staten, 30060
        • Pfizer Investigational Site
      • Tucker, Georgia, Verenigde Staten, 30084
        • Pfizer Investigational Site
    • Illinois
      • Zion, Illinois, Verenigde Staten, 60099
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46202
        • Pfizer Investigational Site
    • Michigan
      • Bloomfield Hills, Michigan, Verenigde Staten, 48302
        • Pfizer Investigational Site
      • Brownstown, Michigan, Verenigde Staten, 48183
        • Pfizer Investigational Site
      • Dearborn, Michigan, Verenigde Staten, 48126
        • Pfizer Investigational Site
      • Detroit, Michigan, Verenigde Staten, 48202
        • Pfizer Investigational Site
      • West Bloomfield, Michigan, Verenigde Staten, 48322
        • Pfizer Investigational Site
    • Mississippi
      • Biloxi, Mississippi, Verenigde Staten, 39532
        • Pfizer Investigational Site
    • Missouri
      • Clarkson Valley, Missouri, Verenigde Staten, 63011
        • Pfizer Investigational Site
      • St. Louis, Missouri, Verenigde Staten, 63141
        • Pfizer Investigational Site
      • St. Louis, Missouri, Verenigde Staten, 63109
        • Pfizer Investigational Site
    • New Jersey
      • Midland Park, New Jersey, Verenigde Staten, 07432
        • Pfizer Investigational Site
      • Morristown, New Jersey, Verenigde Staten, 07962
        • Pfizer Investigational Site
      • Paramus, New Jersey, Verenigde Staten, 07652
        • Pfizer Investigational Site
      • Pompton Plains, New Jersey, Verenigde Staten, 07444
        • Pfizer Investigational Site
      • Ridgewood, New Jersey, Verenigde Staten, 07450
        • Pfizer Investigational Site
      • Summit, New Jersey, Verenigde Staten, 07902
        • Pfizer Investigational Site
      • Westwood, New Jersey, Verenigde Staten, 07675
        • Pfizer Investigational Site
    • New York
      • Bronx, New York, Verenigde Staten, 10451
        • Pfizer Investigational Site
      • Bronx, New York, Verenigde Staten, 10461
        • Pfizer Investigational Site
    • North Carolina
      • Clinton, North Carolina, Verenigde Staten, 28388
        • Pfizer Investigational Site
      • Goldsboro, North Carolina, Verenigde Staten, 27534
        • Pfizer Investigational Site
      • Wilson, North Carolina, Verenigde Staten, 27893
        • Pfizer Investigational Site
    • Oklahoma
      • Del City, Oklahoma, Verenigde Staten, 73115
        • Pfizer Investigational Site
    • Pennsylvania
      • Greensburg, Pennsylvania, Verenigde Staten, 15601
        • Pfizer Investigational Site
      • Hershey, Pennsylvania, Verenigde Staten, 17033-0850
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15213
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15232-1305
        • Pfizer Investigational Site
      • Wexford, Pennsylvania, Verenigde Staten, 15090
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, Verenigde Staten, 38104
        • Pfizer Investigational Site
      • Memphis, Tennessee, Verenigde Staten, 38120
        • Pfizer Investigational Site
      • Memphis, Tennessee, Verenigde Staten, 38133
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, Verenigde Staten, 75230-2510
        • Pfizer Investigational Site
      • Dallas, Texas, Verenigde Staten, 75230
        • Pfizer Investigational Site
      • Fort Worth, Texas, Verenigde Staten, 76177
        • Pfizer Investigational Site
      • Houston, Texas, Verenigde Staten, 77024
        • Pfizer Investigational Site
      • Houston, Texas, Verenigde Staten, 77055
        • Pfizer Investigational Site
      • Plano, Texas, Verenigde Staten, 75093
        • Pfizer Investigational Site
      • Plano, Texas, Verenigde Staten, 75075
        • Pfizer Investigational Site
      • Richardson, Texas, Verenigde Staten, 75080
        • Pfizer Investigational Site
      • San Antonio, Texas, Verenigde Staten, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, Verenigde Staten, 78207
        • Pfizer Investigational Site
      • San Antonio, Texas, Verenigde Staten, 78217
        • Pfizer Investigational Site
      • San Antonio, Texas, Verenigde Staten, 78258
        • Pfizer Investigational Site
      • San Atonio, Texas, Verenigde Staten, 78229
        • Pfizer Investigational Site
      • Tyler, Texas, Verenigde Staten, 75702
        • Pfizer Investigational Site
    • Washington
      • Federal Way, Washington, Verenigde Staten, 98003
        • Pfizer Investigational Site
      • Lakewood, Washington, Verenigde Staten, 98499
        • Pfizer Investigational Site
      • Puyallup, Washington, Verenigde Staten, 98372
        • Pfizer Investigational Site
      • Seattle, Washington, Verenigde Staten, 98104
        • Pfizer Investigational Site
      • Seattle, Washington, Verenigde Staten, 98122
        • Pfizer Investigational Site
      • Tacoma, Washington, Verenigde Staten, 98405
        • Pfizer Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Recurrent or metastatic breast cancer
  • Estrogen receptor (ER), progestin receptor (PR) and HER2/neu receptor (HER2) negative status
  • Prior treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting
  • Relapse following adjuvant chemotherapy within 6 months of last treatment and/or received one or two chemotherapy regimens for advanced disease

Exclusion Criteria:

  • More than two chemotherapy regimens for advanced disease
  • Uncontrolled/symptomatic spread of cancer to the brain

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: B
Geneesmiddel: Chemotherapy

The choice of chemotherapy will be at the discretion of the investigator within the limits outlined below.

  1. Capecitabine - 1000-1250 mg/m2 twice daily days 1-14 every 3 weeks
  2. Vinorelbine - 25-30 mg/m2 rapid intravenous infusion or 60-80 mg/m2 oral weekly, expressed in 3-week cycles
  3. Docetaxel - 75-100 mg/m2 every 3 weeks
  4. Paclitaxel - 175-200 mg/m2 every 3 weeks
  5. Paclitaxel - 80-90 mg/m2 weekly, in a continuous regimen expressed in 3-week cycles or administration of 3 weeks of treatment followed by 1 week of rest. Use of the 3/1 regimen will require extra care in scheduling disease assessments.
  6. Gemcitabine - 800-1250 mg/m2 Days 1 and 8 every 3 weeks Study will continue until disease progression or it is in the best interest of the patient to discontinue based on achievement of maximum benefit or tolerability issues. At the time of progression patients randomized to chemotherapy will be offered crossover to single agent SU011248.
Experimenteel: EEN
Geneesmiddel: SU011248
SU011248 capsules administered orally, daily in a continuous regimen, 3-week cycles, starting dose of 37.5 mg daily. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity. Dose escalate SU011248 to 50-mg daily if minimal toxicities . Study will continue until disease progression. Patients randomized to or crossed over to SU011248 may continue beyond the time of Response Evaluation Criterion in Solid Tumors (RECIST) -defined progression at the discretion of the investigator in the case of clinical benefit.
Andere namen:
  • Sutent, sunitinib malate

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-Free Survival (PFS)
Tijdsspanne: Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)
Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of Participants With Objective Response
Tijdsspanne: Baseline until response or disease progression (up to 3 years from first dose)
Objective response based assessment of confirmed response (CR) or confirmed partial response (PR) according to RECIST. CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with a greater than or equal to (≥) 30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD.
Baseline until response or disease progression (up to 3 years from first dose)
Duration of Response (DR)
Tijdsspanne: Time from first response to disease progression up to 3 years from first dose
Time in months from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time from first response to disease progression up to 3 years from first dose
Survival Probability at 1 Year
Tijdsspanne: Baseline until death (up to 3 years after first dose of study medication)
Probability that the participants will survive at end of 1 year from the first dose of study treatment. Calculated using data collected from baseline until death (up to 3 years after first dose of study medication). Probability calculated from Kaplan-Meier estimate.
Baseline until death (up to 3 years after first dose of study medication)
Overall Survival (OS)
Tijdsspanne: Baseline until death (up to 3 years after first dose of study medication)
Time in months from the date of randomization to date of death due to any cause. OS was calculated as (date of death minus randomization date plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Baseline until death (up to 3 years after first dose of study medication)
Health Related Quality of Life (HRQoL) and Disease Related Symptoms as Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (EORTC-QLQ-C30)
Tijdsspanne: Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal
EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal
HRQoL and Disease Related Symptoms as Measured by EORTC-QLQ-C30 Breast Cancer Module (BR23) Score
Tijdsspanne: Day 1, Cycle 1; Day 1, odd number cycles; and EOT/withdrawal
BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
Day 1, Cycle 1; Day 1, odd number cycles; and EOT/withdrawal
Observed Plasma Trough Concentrations (Ctrough) of Sunitinib
Tijdsspanne: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough of SU012662 (Metabolite of Sunitinib)
Tijdsspanne: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough of Total Drug (Sunitinib + SU012662)
Tijdsspanne: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Dose-corrected Ctrough of Sunitinib
Tijdsspanne: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough = plasma concentration of sunitinib prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Dose-corrected Ctrough of SU012662 (Metabolite of Sunitinib)
Tijdsspanne: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough = plasma concentration of SU012662 prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Dose-corrected Ctrough of Total Drug (Sunitinib + SU012662)
Tijdsspanne: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough = plasma concentration of total drug (Sunitinib + SU012662) prior to study drug administration dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)
Tijdsspanne: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma concentrations of sVEGFR2 were examined as a potential pharmacodynamic marker
Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (sVEGFR3)
Tijdsspanne: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma concentrations of sVEGFR3 were examined as a potential pharmacodynamic marker
Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma Concentration of Soluble Vascular Endothelial Growth Factor A (sVEGF-A)
Tijdsspanne: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma concentrations of sVEGF-A were examined as a potential pharmacodynamic marker
Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma Concentration of Soluble Placental Growth Factor (sPlGF)
Tijdsspanne: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Plasma concentrations of sPlGF were examined as a potential pharmacodynamic marker
Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Plasma Concentration of Soluble Kinase Insert Domain for Tyrosine (sKIT), a Stem Cell Factor Receptor
Tijdsspanne: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Plasma concentrations of sKIT were examined as a potential pharmacodynamic marker
Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Circulating Endothelial Cells (CEC)
Tijdsspanne: Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
Blood samples were collected to enumerate the number of total CECs and sVEGFR1, sVEGFR2 and sVEGFR3 protein expression and/or cellular viability.
Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
Circulating Tumor Cells (CTC)
Tijdsspanne: Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
Blood samples were collected to enumerate the number of total CTCs and insulin growth factor 1R positive (IGF-1R+) CTCs
Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pfizer

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2006

Primaire voltooiing (Werkelijk)

1 mei 2010

Studie voltooiing (Werkelijk)

1 juni 2011

Studieregistratiedata

Eerst ingediend

27 oktober 2005

Eerst ingediend dat voldeed aan de QC-criteria

27 oktober 2005

Eerst geplaatst (Schatting)

30 oktober 2005

Updates van studierecords

Laatste update geplaatst (Schatting)

12 juli 2012

Laatste update ingediend die voldeed aan QC-criteria

2 juli 2012

Laatst geverifieerd

1 juli 2012

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • A6181077

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Borstneoplasmata

Klinische onderzoeken op SU011248

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Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Canada

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

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