- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02544243
Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer
Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Vinorelbine Plus Gemcitabine Versus Vinorelbine Plus Cisplatin
Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.For each randomisation arm, 100 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective.
Study Design:
Arm A Vinorelbine 25 mg/m2 d1, 8;Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks Arm B Vinorelbine 25 mg/m2 d1, 8;Cisplatin 25 mg/m2 d1, 2,3 q 3 weeks
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
Kontakter och platser
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Histologically confirmed metastatic breast cancer
- All patients were required to give written informed consent
- To have received a previous treatment with anthracyclines and taxanes
- Previous radiotherapy is allowed, whenever the radiated area is not the only disease location
- At least 4 weeks since the last previous antineoplastic treatment
- Patients must have recovered from all previous toxicities
- Karnofsky Performance status >= 70%
- Adequate hematological, renal, cardiac and hepatic function
- Life expectancy of at least 12 weeks
- Patients able to comply and to receive an adequate follow-up
Exclusion Criteria:
- Only bone metastases
- Active infection
- Previous treatment with one of the study drugs
- Application of other cytotoxic chemotherapy
- Insufficient renal function (creatinine clearance < 60ml/min)
- Clinically unstable brain metastasis
- Pregnancy or lactation
- Other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin)
- Abnormal liver function (bilirubin > 2.0-fold upper normal limit (UNL); Alanine aminotransferase and aspartate aminotransferase >2.5-fold UNL). In patients with hepatic metastasis, a value of Alanine aminotransferase and aspartate aminotransferase of up to 5-fold UNL is permitted
- Males
- Second malignancy (except for cervix carcinoma in situ or skin carcinoma - no melanoma- with an adequate treatment). Previous malignancies are allowed if disease-free survival is superior to 5 years, except for renal carcinoma or melanoma
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: A
Vinorelbine 25 mg/m2 d1, 8; Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks
|
|
Experimentell: B
Vinorelbine 25 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1,2,3 q 3 weeks
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Progression Free Survival
Tidsram: Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Overall Survival
Tidsram: Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
|
Clinical Benefit Rate
Tidsram: Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
|
Duration of response
Tidsram: Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
|
Incidence of Treatment-Emergent Adverse Events
Tidsram: Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
Safety of treatment will be evaluated by the frequency of adverse events and serious adverse events, clinically significant abnormal laboratory tests, vital signs, and Eastern Cooperative Oncology Group(ECOG)performance status(PS).
All patients who received at least one dose of study treatment will be included in the safety analysis.
|
Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Xinzhao Wang, MD, Shandong Cancer Hospital and Institute
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hudsjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Bröstsjukdomar
- Bröstneoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, fytogena
- Gemcitabin
- Vinorelbin
Andra studie-ID-nummer
- ShandongCHI-05
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Metastaserad bröstcancer
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital och andra samarbetspartnersAvslutadDen kliniska tillämpningsguiden för Conebeam Breast CTKina
-
I-Mab Biopharma Co. Ltd.Inte längre tillgängligSolid Tumor Metastatic Cancer Advanced Cancer
-
ETOP IBCSG Partners FoundationAvslutadBreast Cancer Invasive NosItalien
-
Spanish Breast Cancer Research GroupHoffmann-La Roche; Roche Farma, S.AAvslutadBreast Cancer Invasive NosSpanien
-
University Health Network, TorontoAvslutadBreast Cancer Invasive Nos | Primär invasiv bröstcancerKanada
-
Novartis PharmaceuticalsAvslutadMetastaserad bröstcancer (MBC) | Locally Advance Breast Cancer (LABC)Storbritannien, Spanien
-
Pomeranian Medical University SzczecinMaria Sklodowska-Curie National Research Institute of Oncology; Regional...OkändBRCA1-mutation | Breast Cancer Invasive NosPolen
-
PfizerAvslutadBRAF eller NRAS Mutant Metastatic MelanomFörenta staterna, Nederländerna, Italien, Tyskland, Schweiz
-
McMaster UniversityCanadian Breast Cancer FoundationAvslutadBreast Cancer Invasive Nos | Steg 0 BröstkarcinomKanada
-
Sunnybrook Health Sciences CentrePfizerAvslutadClear Cell Metastatic Renal Cell CarcinomKanada
Kliniska prövningar på Gemcitabin
-
Sierra Oncology LLC - a GSK companyAvslutadAvancerade solida tumörerSpanien, Storbritannien
-
University of Erlangen-Nürnberg Medical SchoolAvslutadBukspottskörtelcancerTyskland
-
AstraZenecaRekryteringGallvägscancerFrankrike, Spanien, Italien, Korea, Republiken av, Japan, Tyskland, Förenta staterna, Singapore
-
Shenzhen University General HospitalHar inte rekryterat ännu
-
Fifth Affiliated Hospital, Sun Yat-Sen UniversityRekrytering
-
Kansai Hepatobiliary Oncology GroupAvslutad
-
3D Medicines (Sichuan) Co., Ltd.Har inte rekryterat ännuNeoplasmer i gallvägarna
-
Samsung Medical CenterAvslutadBukspottskörtelcancerKorea, Republiken av
-
University of ZurichAvslutadBukspottskörtelcancerFrankrike, Schweiz, Belgien, Tyskland
-
3D Medicines (Sichuan) Co., Ltd.RekryteringNeoplasmer i gallvägarnaKina