A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer
8. december 2015 opdateret af: Kathy Miller, MD, Hoosier Cancer Research Network
Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01
The proposed trial provides a unique opportunity in that it combines genomic, proteomic, and pharmacogenomic assessments in patients receiving the most commonly used chemotherapies for advanced breast cancer.
To date no other trial has analyzed gene and protein expression at the same time points in the same patient, combined with clinical outcome.
Similar to previous attempts to predict response based on expression of a single gene or protein, the researchers expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy.
Rather, the researchers expect an iterative process that combines information gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
OUTLINE: This is a 4 arm, multi-center study.
Sample Collection:
- Core Biopsy
- Serum
- Urine
Treatment Regimens (Investigator/Patient Discretion):
- Arm A: Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
- Arm B: Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
- Arm C: Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
- Arm D: Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle
Performance status & Organ Function:
Performance status and organ function appropriate for chemotherapy in the opinion of the treating investigator according to Good Clinical Practice (GCP).
Life Expectancy: Not specified
Hematopoietic: Not specified
Hepatic: Not specified
Renal: Not specified
Cardiovascular: Not specified
Pulmonary: Not specified
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
80
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Indiana
-
Bloomington, Indiana, Forenede Stater, 47403
- Cancer Care Center of Southern Indiana
-
Fort Wayne, Indiana, Forenede Stater, 46815
- Fort Wayne Oncology & Hematology, Inc
-
Goshen, Indiana, Forenede Stater, 46527
- Center for Cancer Care at Goshen Health System
-
Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University Cancer Center
-
Indianapolis, Indiana, Forenede Stater, 46256
- Community Regional Cancer Center
-
Indianapolis, Indiana, Forenede Stater, 46227
- Mary Lou Mayer, M.D.
-
Lafayette, Indiana, Forenede Stater, 47905
- Horizon Oncology Center
-
Lafayette, Indiana, Forenede Stater, 47904
- Arnett Cancer Care
-
South Bend, Indiana, Forenede Stater, 46601
- Northern Indiana Cancer Research Consortium
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine - Methodist Breast Center
-
-
-
-
-
Lima, Peru
- Instituto de Enfermedades Neoplasticas (INEN)
-
-
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
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Study limited to patients with breast cancer.
Beskrivelse
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease.
- Disease amenable to pre-treatment core or incisional biopsy with adequate tissue for histology and genomic/proteomic analysis.
- Measurable disease as assessed within 21 days prior to being registered for protocol therapy by RECIST.
Planned chemotherapy with one of the following regimens:
- Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
- Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
- Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
- Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle
Exclusion Criteria:
- No serious uncontrolled medical or surgical condition that the investigator feels might compromise study participation.
- Negative pregnancy test obtained within 7 days prior to being registered for protocol therapy for women of child bearing potential.
- Unwillingness to use adequate contraception (or practicing complete abstinence). Subjects should be advised that adequate contraception (or complete abstinence) must be continued while on treatment and for a period of 3 months after the final dose of chemotherapy.
- No breast-feeding.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
A
Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 2 of every 21-day cycle
|
core biopsy
serum collection
urine collection
Doxorubicin 60 mg/m2 day 1 of every 21-day cycle
Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
|
|
B
Capecitabine 1000mg/m2 bid days 1-14 of every 21-day cycle
|
core biopsy
serum collection
urine collection
Capecitabine 1000 mg/m2 bid days 1-14 of every 21-day cycle
|
|
C
Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
|
core biopsy
serum collection
urine collection
Vinorelbine 25mg/m2 days 1, 8, 15 of every 28-day cycle
|
|
D
Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle
|
core biopsy
serum collection
urine collection
Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer
Tidsramme: 36 months
|
36 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To correlate serum and tumor proteomic profiles with response to commonly used chemotherapies.
Tidsramme: 36 months
|
36 months
|
|
To compare serum and tissue proteomic analyses.
Tidsramme: 36 months
|
36 months
|
|
To compare genomic and proteomic profiles.
Tidsramme: 36 months
|
36 months
|
|
To correlate toxicity and/or response with drug-specific pharmacogenomic parameters.
Tidsramme: 36 months
|
36 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: George Sledge, M.D., Hoosier Oncology Group, LLC
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.
Hjælpsomme links
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. september 2005
Primær færdiggørelse (Faktiske)
1. december 2010
Studieafslutning (Faktiske)
1. december 2010
Datoer for studieregistrering
Først indsendt
6. oktober 2005
Først indsendt, der opfyldte QC-kriterier
6. oktober 2005
Først opslået (Skøn)
10. oktober 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. december 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. december 2015
Sidst verificeret
1. december 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hudsygdomme
- Neoplasmer
- Neoplasmer efter sted
- Brystsygdomme
- Brystneoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antirheumatiske midler
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Antineoplastiske midler, fytogene
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Antibiotika, antineoplastisk
- Gemcitabin
- Cyclofosfamid
- Capecitabin
- Doxorubicin
- Vinorelbin
Andre undersøgelses-id-numre
- HOG COE-01
- Department of Defense BC030400 (Registry Identifier: ClinicalTrials.Gov)
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 .