- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04131881
The Consistency of Drug Screening in Vitro and Neoadjuvant Chemotherapy Results in Breast Cancer Patients
16. oktober 2019 oppdatert av: Peking University People's Hospital
The Consistency of Drug Sensitivity in Vitro and Neoadjuvant Chemotherapy Results in Vivo for Early Breast Cancer Patients
Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be resectable and improve breast conservation rate.
Patients with triple negative or Her2 enriched subtype who achieved pCR after neoadjuvant chemotherapy would have better survival.
But the overall pCR rate of breast cancer was about 20%.
And patients with luminal like subtype were less reactive for neoadjuvant chemotherapy.
Improving pCR rate maybe could achieve better survival.
So, different methods have tried to select effective drug before chemotherapy.Drug sensitivity screening in vitro for different chemotherapy drugs was a promising method.
This study will explore whether drug screening by culturing breast cancer cells in vitro from breast cancer tissue could consistent with neoadjuvant chemotherapy in patients.40
breast cancer patients were recruited.The results of drug sensitivity in vitro and pathological evaluation after neoadjuvant chemotherapy were compared whether they were consistent.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be resectable and improve breast conservation rate.
Patients with triple negative or Her2 enriched subtype who achieved pCR after neoadjuvant chemotherapy would have better survival.
But the overall pCR rate of breast cancer was about 20%.
And patients with luminal like subtype were less reactive for neoadjuvant chemotherapy.
Improving pCR rate maybe could achieve better survival.
So, different methods have tried to select effective drug before chemotherapy.Drug sensitivity screening in vitro for different chemotherapy drugs was a promising method.
This study will explore whether drug screening by culturing breast cancer cells in vitro from breast cancer tissue could consistent with neoadjuvant chemotherapy in patients.40
breast cancer patients who would receive neoadjuvant chemotherapy were recruited.Breast cancer tissues were obtained before chemotherapy.
The breast cancer cells were cultured in unadhesive dishes.
Chemotherapy drugs were put in dishes and drug sensitivity were evaluated.
Patients received operation and pathological evaluationc after neoadjuvant chemotherapy.
The results of drug sensitivity in vitro and pathological evaluation after neoadjuvant chemotherapy were compared whether they were consistent.
Studietype
Observasjonsmessig
Registrering (Faktiske)
45
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100044
- Peking University People's Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Patients in this study were invasive early breast cancer patients who were candidate for neoadjuvant chemotherapy.
Beskrivelse
Inclusion Criteria:
- invasive breast cancer candidates for neoadjuvant chemotherapy agreed to participate in this observative experiments could receive operation normal liver and renal function
Exclusion Criteria:
- inflammatory breast cancer recurrent breast cancer
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Consistency rate of drug sensitivity in vitro and in vivo
Tidsramme: through study completion, an average of 2 years
|
Compute the percentage of patients whose drug sensitivity were consistent between in vitro and in vivo, as both were sensitive or insensitive.
|
through study completion, an average of 2 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: shu wang, doctor, Peking University People's Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. april 2017
Primær fullføring (Faktiske)
1. mai 2019
Studiet fullført (Faktiske)
1. september 2019
Datoer for studieregistrering
Først innsendt
13. oktober 2019
Først innsendt som oppfylte QC-kriteriene
16. oktober 2019
Først lagt ut (Faktiske)
18. oktober 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. oktober 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. oktober 2019
Sist bekreftet
1. oktober 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PKUPH10B002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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. .