- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04941885
Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus Aromatase Inhibitor in Metastatic HER2+/HR+ Breast Cancer (Increase)
1. juli 2021 opdateret af: wang shusen, Sun Yat-sen University
A Phase II Single-arm Clinical Trial of the Efficacy and Tolerability of Inetetamab Combined With Cyclophosphamide Metronomic Chemotherapy and Aromatase Inhibitor in Metastatic HER2+/HR+ Breast Cancer
Antibody-dependent cell-mediated cytotoxicity (ADCC) is one of the important mechanisms for suppressing tumors of Trastuzumab.
Pre-clinical data suggest that the ADCC effect of Inetetamab, an anti-HER2 monoclonal antibody with a modified Fc segment, is 1.11 times that of trastuzumab.
Previous studies indicated that enhanced ADCC effects can be transformed into clinical benefits.
Immune induction through cyclophosphamide metronomic chemotherapy may further enhance the ADCC effect of anti-HER2 monoclonal antibodies.
Therefore, we conducted this study to explore the efficacy and the safety of Inetetamab combined with cyclophosphamide metronomic chemotherapy and aromatase inhibitors(AI) in the treatment of metastatic HER2-positive and HR-positive breast cancer patients and to explore the possible mechanisms.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Trastuzumab is a humanized monoclonal antibody, and antibody-dependent cell-mediated cytotoxicity (ADCC) is one of its important mechanisms for suppressing tumors.
Pre-clinical data suggest that the ADCC effect of Inetetamab, an anti-HER2 monoclonal antibody with a modified Fc segment, is 1.11 times that of trastuzumab.
Previous studies indicated that enhanced ADCC effects can be transformed into clinical benefits, but the absolute benefits are still unsatisfactory.
Further improvement of ADCC effects and monoclonal antibody-induced immune responses may improve the clinical benefits.
Immune induction through cyclophosphamide metronomic chemotherapy may further enhance the ADCC effect of anti-HER2 monoclonal antibodies.
According to previous clinical studies, for HR-positive and HER2-positive metastatic breast cancer patients, metronomic chemotherapy combined with endocrine therapy and anti-HER2 targeted therapy may be one of the treatment options.
Therefore, we conducted this study to explore the efficacy and the safety of Inetetamab combined with cyclophosphamide metronomic chemotherapy and aromatase inhibitors(AI) in the treatment of metastatic HER2-positive and HR-positive breast cancer patients, and we further exploring the possible mechanisms.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
78
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: shusen wang, MD
- Telefonnummer: +86-13926168469
- E-mail: wangshs@sysucc.org.cn
Undersøgelse Kontakt Backup
- Navn: Kuikui Jiang, MD
- Telefonnummer: +86-15210589011
- E-mail: jiangkk@sysucc.org.cn
Studiesteder
-
-
Guangdong
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Guangzhou, Guangdong, Kina, 510060
- Rekruttering
- Shusen Wang
-
Kontakt:
- shusen wang, MD
- Telefonnummer: +86-13926168469
- E-mail: wangshs@sysucc.org.cn
-
-
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 til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Voluntarily sign the informed consent form;
- 18-75 years old;
- The expected survival period is ≥12 weeks;
- Eastern Cooperative Oncology Group (ECOG) score [0-2] points;
- The diagnosis of invasive carcinoma by histology or cytology; Estrogen receptor (ER) positive (defined as >1% nuclear ER staining); HER2 negative (defined as IHC 0 or 1+, or HER2(2+) with HER2 FISH detection no amplification);
- Inoperable or recurrent/metastatic breast cancer patients with aromatase inhibitor treatment failure;
- In the state of disease progression before enrollment;
- Measurable disease according to RECIST version 1.1 or only bone metastasis;
- Adequate hematological, hepatic and renal function;
- NYHA class I or II and Left ventricular ejection fraction (LVEF) ≥50%.
- The diagnosis of invasive carcinoma by histology or cytology: Hormone receptor (HR) positive (defined as >1% nuclear estrogen receptor staining); HER2 positive (defined as IHC 3+, or HER2 FISH detection amplification);
- In the state of disease progression before enrollment;
- Have lesions able to and agree to perform tissue biopsy at the time requested in the study;
- Treatment ≥1 line after recurrence/metastasis, or relapse within 12 months after completing trastuzumab-based adjuvant therapy or during trastuzumab adjuvant therapy;
- Previously received trastuzumab for anti-HER2 therapy;
- Measurable disease according to RECIST version 1.1.
Exclusion Criteria:
- Allergic to the ingredients of Inetetamab, cyclophosphamide or similar drugs;
- Concomitant diseases/conditions that is not controllable, and any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the patient's participation in this study;
- Patients who cannot accept drugs orally;
- Women who are pregnant or breastfeeding or planning to give birth;
- Patients with currently symptomatic brain or meningeal metastasis;
- History of other primary malignancy;
- Resistant to steroidal or nonsteroidal aromatase Inhibitor;
- Have used Inetetamab;
- Patients with life-threatening, symptomatic, metastatic visceral disease.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
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 |
|---|---|
|
Eksperimentel: Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AI
Each participant receives Inetetamab(8mg/kg iv day 1 followed by 6mg/kg iv day 1, cycled every 21 days) plus cyclophosphamide metronomic chemotherapy(50mg once a day orally) plus aromatase(once a day orally).
|
Each participant receives Inetetamab plus cyclophosphamide metronomic chemotherapy plus AI.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Objektiv svarprocent (ORR)
Tidsramme: 1 år
|
Andelen af bedste overordnede respons af enten fuldstændig eller delvis respons.
|
1 år
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical benefit rate (CBR)
Tidsramme: 1 year
|
Response and progression will be evaluated using RECIST 1.1.
Evaluation will occur every 3 months till progression or termination of the study.
CBR is defined as ratio of participants who have stable disease for over 24 weeks.
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1 year
|
|
Progression free survival (PFS)
Tidsramme: 1 year
|
Time from the date of treatment to the date of tumor progression.
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1 year
|
|
Duration of response (DOR)
Tidsramme: 1 year
|
Time from the first assessment of the tumor as complete or partial response to the first assessment as PD (Progressive Disease) or death from any cause.
|
1 year
|
|
Samlet overlevelse (OS)
Tidsramme: 3 år
|
Tid fra behandlingsdato til dødsdato.
|
3 år
|
|
Antal deltagere med uønskede hændelser
Tidsramme: 1 år
|
Antal deltagere med bivirkninger relateret til behandlingen.
|
1 år
|
|
The quality of life
Tidsramme: 1 year
|
Using Functional Assessment of Cancer therapy -Breast (FACT-B) scale.
The minimum and maximum values are 0 and 144, respectively.
Higher scores mean better outcome.
|
1 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Shusen Wang, MD, Sun Yat-sen University
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 (Forventet)
25. juni 2021
Primær færdiggørelse (Forventet)
1. juli 2023
Studieafslutning (Forventet)
1. juli 2025
Datoer for studieregistrering
Først indsendt
25. juni 2021
Først indsendt, der opfyldte QC-kriterier
25. juni 2021
Først opslået (Faktiske)
28. juni 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juli 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2021
Sidst verificeret
1. juli 2021
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
- Antirheumatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Cyclofosfamid
Andre undersøgelses-id-numre
- SYSU-2021
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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