- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02591966
Genetic Alteration After Systemic Treatment in Breast Cancer
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Prospective single arm trial using three patients' cohorts. One-hundred patients for each cohort and a total of 300 patients (600 biopsy samples) will be entered to this trial.
The hypothesis is that genomic alterations measured by CancerSCAN and cfDNA, Whole exome sequencing (WES), Whole transcriptome sequencing (WTS), FACS(Fluorescence-Activated Cell Sorting), cytokine and immunologic signature analysis would be different between pre- and post-menopausal women and would be predictive biomarkers for each cohort according to pre- and post-menopausal status. Three groups of patients will be recruited:
- The patients who receive neoadjuvant systemic treatments:
- The patients who have distant metastatic sites at first and recur from surgery:
- The patients who are going to receive first-line chemotherapy
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Seoul, Korea, Republikken, 135-710
- Rekruttering
- Samsung Medical Center
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Ta kontakt med:
- Yeon Hee Park, MD, Ph.D
- Telefonnummer: 82-2-3410-3459
- E-post: yeonh.park@samsung.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
- The patients who receive neoadjuvant systemic treatments:
- The patients who have distant metastatic sites at first and recur from surgery:
- The patients who are going to receive first-line chemotherapy:
Beskrivelse
Inclusion Criteria:
- Patients older than 20 years
Patients with histologically confirmed breast cancer at three disease status
- Patients who are going to receive neoadjuvant chemotherapy with feasible biopsy site.
- Patients who recur from curative surgery and have distant metastasis with feasible biopsy site. ; Patients must have received adjuvant chemotherapy after curative surgery.
- Patients who are going to first-line palliative chemotherapy with feasible biopsy site.
- Patients with PS ECOG 0 - 2
- Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- Written informed consent form
Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to study as defined below:
- Haemoglobin ≥9.0 g/L (transfusion allowed)
- White blood cells (WBC) > 3 x 109/L
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN
Exclusion Criteria:
- Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety.
- Double primary cancer (except for any cancer in remission for > 5 years, cervix cancer in situ, basal cell cancer in situ, any in situ cancers that are resected)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Biomarker group
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Genomic profiling will be assessed by tissue sampling and blood.
Tidsramme: 2year
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Tissue and blood will be tested for CancerSCAN, cfDNA, WES, WTS, FACS, cytokine and immunologic signature analysis platform.NAC to study the multiscale relationships among DCE-MRI features, NGS data, and pathologic response to NAC and to evaluate the role of radiogenomics in predicting pathologic response of the patients.
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2year
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2014-11-015
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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