- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05019690
Apatinib Combined With Albumin-Bound Paclitaxel for Treatment of Advanced Triple Negative Breast Cancer
Apatinib Mesylate Combined With Albumin-bound Paclitaxel for Second-line Treatment of Advanced Triple Negative Breast Cancer:a Single-arm,Exploratory Clinical Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a exploratory, single-arm, open-label trial. The investigator's primary purpose is to explore that PFS and safety of apatinib combined with albumin-bound paclitaxel for treatment of advanced triple negative breast cancer.
In treatment period, patients will be administrated apatinib plus albumin-bound paclitaxel, every 21 days for 1 cycle, until disease progression, toxicity intolerance, withdrawal of informed consent, patients judged must be terminated study termination.
The imaging evaluation was performed according to the RECIST 1.1 criteria every 6 weeks.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: weiwei Huang
- Telefonnummer: 13763893896
- E-mail: huangstudenth@163.com
Studiesteder
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Fujian
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Fuzhou, Fujian, Kina
- Fujian Cancer Hospital
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Kontakt:
- weiwei Huang
- Telefonnummer: 13763893896
- E-mail: huangstudenth@163.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
1.Volunteered to participate in the study, signed the informed consent form. 2.Aged 18-75 years,female. 3.Histologically or pathologically confirmed advanced triple-negative breast cancer that meets the following criteria:
- Primary tumor stage determined by standard evaluation methods: CT0-4 /N0-3/M1;
- Pathologically confirmed breast cancer with negative HER2 expression, defined as < 10% immunoreactive cells with an IHC score of + or -,or in situ hybridization (ISH) resulting in no HER2 gene amplification (RATIO of HER2 gene signal to centromeric 17 signal < 2.0 and HER2 gene copy number/cell < 4.0);
- Negative hormone receptor status (ER and PgR) is known, which is defined as < 1% detected by immunohistochemistry;
- A previous systemic therapy, including anthracyclines, for recurrence/metastasis.
4.With measurable lesions,according to Response Evaluation Criteria In Solid Tumors Version 1.1.
5.Patients must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale.
6.Life expectancy ≥12 weeks. 7.No prior treatment with apatinib or albumin paclitaxel, except in neoadjuvant or adjuvant therapy.
8.Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥80g/L (without blood transfusion during 14 days); a leucopenia count of ≥3.0×109/L; a platelet count of ≥90×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
9.Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug.
Exclusion Criteria:
1.Pregnant or lactating women. 2.Previous or coexisting malignancies, unless they are basal cell carcinoma of the skin, superficial bladder carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in situ, or other cancers in situ that have achieved complete remission at least 5 years prior to screening and that do not require or are expected to require additional treatment during the study.
3.Patients with consciousness disorder or unable to cooperate with treatment, with mental illness or metastasis of central nervous system.
4. Patients who have participated in other clinical trials in the past three months.
5. Previous treatment with apatinib or other vaso-targeting drugs and other small-molecule tyrosine kinase inhibitors.
6. Received any targeted treatment before enrollment, including but not limited to the following: surgical treatment, chemotherapy, radiation therapy, targeted therapy, etc.
7. Within 3 months before treatment, esophageal (fundus) varices were ruptured and bleeding, intestinal obstruction and gastrointestinal perforation.
8. The subject has clinical symptoms of cancerous ascites or pleural effusion. 9. Subjects have active infection or unexplained fever ≥38.5℃ within 7 days before enrollment.
10. Severe liver, kidney, heart, lung, brain and other major organ failure. 11. Patients with hypertension who cannot be reduced to the normal range after antihypertensive drug therapy (systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg).
12. Past or present idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, tissue pneumonia (e.g., bronchitis, angiitis oblitans), drug pneumonia, or screening CT with active pneumonia.
13. Patients with abnormal coagulation (INR > 1.5 or PROthrombin time (PT) > ULN+4 SEC), who are prone to bleeding, or who are receiving thrombolytic or anticoagulant therapy, are permitted to receive low-dose low-molecular heparin or oral aspirin procoagulant therapy during the trial.
14. Have cardiac clinical symptoms or disease that are not well controlled, e.g. :(1) nyha grade 2 Above heart failure;(2) Unstable angina;(3) Myocardial infarction occurred within 1 year;(4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;(5) QTc > 470ms.
15. Patients with positive protein urine (urine protein test of 2+ or above, or 24 h urine protein quantification > 1.0g).
16. Inability to swallow pills, malabsorption syndrome, or any condition that affects gastrointestinal absorption.
17. Overactivity/venous thrombosis events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, occurred within 6 months before enrollment.
18. A history of hereditary or acquired bleeding or coagulation disorders.Within 3 months before enrollment, patients with clinically significant bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.
19. According to the investigator's judgment, the subjects have other factors that may lead to the forced termination of the study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which may affect the safety of the subjects or the data collection, etc.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Apatinib Combined With Albumin-Bound Paclitaxel
Participants will receive apatinib combined with albumin-bound paclitaxel until predefined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
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Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet,QD,Q3W
Subjects receive Albumin-Bound Paclitaxel,ivgtt, Strength: 125 mg/m^2,d1、7、15,Q3W
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Progressionsfri overlevelse (PFS)
Tidsramme: Fra indskrivning til 12 måneder
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PFS blev defineret som tiden fra randomisering til første dokumenterede sygdomsprogression (PD) ved brug af responsevalueringskriterier i solide tumorer 1.1 (RECIST 1.1) eller død af enhver årsag, alt efter hvad der indtrådte først. For mållæsioner blev PD defineret som en stigning på mindst 20 % i summen af den længste diameter af mållæsioner, idet man tog som reference den mindste sum af den længste diameter, der er registreret siden behandlingen startede, eller fremkomsten af 1 eller flere nye læsioner. For ikke-mål-læsioner blev PD defineret som forekomsten af 1 eller flere nye læsioner og/eller utvetydig progression af eksisterende ikke-mål-læsioner. PFS vil blive estimeret ved hjælp af Kaplan-Meier metoden. En Kaplan-Meier kurve, median PFS, hazard ratio med passende konfidensintervaller vil blive rapporteret. |
Fra indskrivning til 12 måneder
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Objektiv svarprocent (ORR)
Tidsramme: Fra indskrivning til 12 måneder
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ORR blev defineret som procentdelen af deltagere med bedste (bekræftede) overordnede respons (BOR) af enten CR eller PR. ORR blev vurderet af investigator i henhold til RECIST version 1.1 og er baseret på BOR, som er defineret som bedste respons registreret fra start af undersøgelsesbehandling til sygdomsprogression/-tilbagefald eller død. Deltagerne skulle have to på hinanden følgende vurderinger af PR eller CR for at være en responder. Kun deltagere med målbar sygdom ved baseline blev inkluderet i analysen af BOR, og som ikke havde nogen evaluerbare post-baseline vurderinger blev klassificeret som ikke evaluerbare. ORR vil blive rapporteret i procent med hver arm og passende konfidensintervaller. |
Fra indskrivning til 12 måneder
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Samlet overlevelse (OS)
Tidsramme: Fra indskrivning til 24 måneder
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Samlet overlevelse (OS), defineret som tiden fra randomiseringsdatoen til dødsdatoen, uanset dødsårsagen. Deltagere, der var i live på tidspunktet for analysen, blev censureret på datoen for den sidste opfølgende vurdering. Deltagere uden opfølgende vurdering blev censureret på dagen for sidste undersøgelsesmedicin, og deltagere uden post-baseline-information blev censureret på datoen for randomisering. OS vil blive estimeret ved hjælp af Kaplan-Meier metoden. En Kaplan-Meier kurve, median OS, hazard ratio med passende konfidensintervaller vil blive rapporteret. |
Fra indskrivning til 24 måneder
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Disease control rate(DCR)
Tidsramme: From enrollment to 12 month
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DCR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR or SD. DCR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR or SD to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable. The DCR will be reported by percentage with each arms and appropriate confidence intervals. [Time Frame: From enrollment to 12 month] |
From enrollment to 12 month
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hudsygdomme
- Neoplasmer
- Neoplasmer efter sted
- Brystsygdomme
- Brystneoplasmer
- Tredobbelt negative brystneoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Proteinkinasehæmmere
- Paclitaxel
- Albumin-bundet Paclitaxel
- Apatinib
Andre undersøgelses-id-numre
- Arise-FJ-B02
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .
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