- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04973319
Trastuzumab Combined With Pertuzumab for Adjuvant Treatment of Breast Cancer After Neoadjuvant Therapy
13. Juli 2021 aktualisiert von: Caigang Liu, Shengjing Hospital
Trastuzumab Combined With Pertuzumab and Sequential Use of Pyrotinib vs. Trastuzumab Combined With Pertuzumab for Adjuvant Treatment of Breast Cancer After Neoadjuvant Therapy
Patients with HER-2 positive breast cancer who have poor outcomes after endocrinotherapy and standard chemotherapy can be significantly improved by the use of anti-HER-2 monoclonal antibody trastuzumab.
In the current clinical practice of neoadjuvant therapy, trastuzumab combined with chemotherapy can significantly increase the pCR and improve the outcomes in patients.
However, there seems to be no available treatment for patients who have no pCR and still have residual tumors except for sequential trastuzumab treatment for 1 year.
Compared with trastuzumab, a HER-2 macromolecule inhibitor, pyrotinib has a different site of action and an increased EGFR target.
Compared with lapatinib, a small molecule inhibitor of EGFR and HER-2, pyrotinib is an irreversible inhibitor, with the ability to achieve a better curative effect at a lower human plasma exposure level.
This trial is designed to evaluate the effectiveness and safety of trastuzumab combined with pertuzumab followed by sequential pyrotinib treatment in non-pCR patients after neoadjuvant therapy.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
In recent years, the interest has greatly increased in how to proceed with postoperative intensive adjuvant therapy for early breast cancer patients who have not reached pCR and still have residual lesion after neoadjuvant therapy.
Relevant efficacy and safety data have been continuously verified in clinical trials, and some treatments have been clinically approved.
Moreover, new attempts and explorations are still going on in clinical practice.
Based on the preliminary clinical findings, it is planned to design a randomized controlled, open-label, multi-center phase III clinical study that will explore the efficacy of trastuzumab combined with pertuzumab for 1 year followed by sequential pyrotinib vs. touzumab combined with pertuzumab for 1 year, aiming to verify that dual-target adjuvant therapy with sequential use of pyrotinib maleate tablets is superior to dual-target adjuvant therapy alone in HER-2 positive early breast cancer patients who have not reached pCR after neoadjuvant therapy.
If this clinical trial achieves a positive result, the use of pyrotinib maleate tablets will be promoted for early breast cancer patients who have not reached pCR and still have residual tumor lesions after neoadjuvant therapy with an attempt to further achieve improved outcomes and prognosis.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
450
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Nan Niu, MD
- Telefonnummer: 8618940256668
- E-Mail: niunannancy@163.com
Studienorte
-
-
Liaoning
-
Shenyang, Liaoning, China, 110004
- Shengjing Hospital affiliated to China Medical University
-
Kontakt:
- Nan Niu, MD
- Telefonnummer: 8618940256668
- E-Mail: niunannancy@163.com
-
Hauptermittler:
- Cai-Gang Liu, MD
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
Inclusion Criteria:
- Female patients aged ≥ 18 but ≤ 75 years (The maximal age of the subjects enrolled in the Phase 3 study of pyrotinib is 75 years old, and there is no safety data for the use of the drug in older people);
- ECOG level 0-1;
- Primary infiltrating breast lesions and lymph nodes should follow these conditions at the same time: histologically confirmed invasive breast cancer; receiving neoadjuvant treatment and completing the operation, with postoperative pathological examination indicating residual invasive cancer in the breast or axillary lymph nodes; HER2-positive breast cancer is confirmed in the pathology test, with 3+ in immunohistochemistry (IHC) test and HER2 gene amplification (HER2/CEP17 ≥ 2.0 or average HER2 copy number/cell number ≥ 6); no recurrent and metastatic disease after surgery;
- HER-2 positive breast cancer patients who have non-pCR after trastuzumab+pertuzumab as neoadjuvant therapy, and have completed trastuzumab combined with pertuzumab as adjuvant treatment. During the neoadjuvant and/or adjuvant therapy phase, at least ≥24 weeks (8 drug delivery cycles) of trastuzumab + pertuzumab. And the time interval from the end of the last trastuzumab treatment to entering the trial must be ≤ 1 year;
- Hormone receptor status (ER and PR) that is known;
- The functional level of major organs must conform to the following requirements (no blood transfusion, no use of white blood cell- and platelet-increasing drugs within 2 weeks before screening): Neutrophils (ANC) ≥ 1.5×109/L; Platelet count (PLT) ≥ 90×109/L; Hemoglobin (Hb) ≥ 90 g/L; Total bilirubin (TBIL)≤ 1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5×ULN;
- Female patients who are not menopausal or not surgically sterilized agree to abstain from sex or use effective non-hormonal drugs for contraception during the treatment period and within 8 weeks after the last administration;
- Patients who participate in the trial voluntarily, sign an informed consent, have good compliance and are willing to comply with the follow-up visit.
Exclusion Criteria:
- With a history of recurrent local or regional breast disease;
- Stage IV (metastatic) breast cancer;
- Bilateral breast cancer;
- With a history of any malignancies other than breast cancer in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma;
- Patients who have received pyrotinib, lapatinib, neratinib or other tyrosine kinase inhibitors, enmetrastuzumab (T-DM1), and other anti-tumor biological therapies or tumor immunotherapy;
- Patients who are receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;
- Severe heart disease or discomfort, including but not limited to the following diseases: a confirmed history of heart failure or systolic dysfunction (LVEF < 50%); high-risk uncontrolled arrhythmia, such as atrial tachycardia, remarkable ventricular arrhythmia (such as ventricular tachycardia) or higher-grade atrioventricular block; angina pectoris requiring anti-angina medication; clinically significant valvular disease; transmural myocardial infarction shown by ECG; uncontrolled blood pressure in patients with hypertension who have been given antihypertensive drugs (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg);
- Inability to swallow, intestinal obstruction or other factors that affect drug taking and absorption;
- With a history of diagnosed neurological or mental disorders, including involuntary behavior or mental illness;
- With a history of gastrointestinal diseases with diarrhea as the main symptom;
- Patients who are known to have a history of allergies to the drug components in this trial; have a history of immunodeficiency, including HIV positive results, or other acquired or congenital immunodeficiency diseases; or have a history of organ transplantation;
- Female patients during pregnancy and lactation, or those who are fertile and positive for baseline pregnancy test;
- Serious concomitant diseases or other comorbid diseases that will interfere with the planned treatment, including infectious diseases with active infections (including but not limited to hepatitis B, active hepatitis C, active tuberculosis, active syphilis, etc.); or any other cases in which the investigator believes that the patient cannot participate in the trial.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: test group
Each subject in the test group will receive the test drug (pyrotinib) for 52 weeks, and will be followed up for at least 3 years from the start of randomization, until disease recurrence, intolerable toxicity, withdrawal of informed consent, or termination of the medication as per the investigator's judgment.
The subject who has a second primary malignant tumor in a non-breast area will continue to be followed up until a recurrent disease or death due to primary breast cancer.
The subjects who are hormone receptor-positive will be advised to receive endocrinotherapy simultaneously.
Within 28 days after the last administration of the test drug, the subjects in the test group must complete the safety follow-up and the end-of-treatment visit and continue to receive the follow-up visit.
|
Each subject in the test group will receive the test drug (pyrotinib) for 52 weeks, and will be followed up for at least 3 years from the start of randomization, until disease recurrence, intolerable toxicity, withdrawal of informed consent, or termination of the medication as per the investigator's judgment.
Andere Namen:
|
Sonstiges: control group
Each enrolled subject will complete at least ≥ 24 weeks (8 drug delivery cycles) of trastuzumab combined with pertuzumab in the neoadjuvant and/or adjuvant treatment phase.
|
Each enrolled subject will complete at least ≥ 24 weeks (8 drug delivery cycles) of trastuzumab combined with pertuzumab in the neoadjuvant and/or adjuvant treatment phase.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Invasive Disease-Free Survival (IDFS)
Zeitfenster: at least 3 years from the beginning of randomization.
|
the time from the date of randomization to the first appearance of recurrent disease.
Recurrent diseases include ipsilateral or contralateral breast cancer, local or regional recurrence, distant recurrence and death from any cause.
|
at least 3 years from the beginning of randomization.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Disease-Free Survival (DFS)
Zeitfenster: at least 3 years from the date of randomization
|
the time from the date of randomization to the first occurrence of any recurrent disease.
Recurrent diseases include second primary malignant tumor in the non-breast region and preinvasive cancer in the breast duct.
|
at least 3 years from the date of randomization
|
overall survival (OS)
Zeitfenster: at least 3 years from the date of randomization
|
the time from the date of randomization to death due to any cause.
|
at least 3 years from the date of randomization
|
Distant Disease-Free Survival (DDFS)
Zeitfenster: at least 3 years from the date of randomization
|
the time from the date of randomization to the first occurrence of distant recurrence or death from any cause
|
at least 3 years from the date of randomization
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Adverse event (AE)
Zeitfenster: from the date of randomization to no more than 28 days after the last drug withdrawal.
|
AEs will be assessed as per the NCI-CTC AE 5.0 standard.
|
from the date of randomization to no more than 28 days after the last drug withdrawal.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Cai-Gang Liu, MD, Department of Breast Surgery, Shengjing Hospital affiliated to China Medical University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Voraussichtlich)
1. August 2021
Primärer Abschluss (Voraussichtlich)
1. August 2027
Studienabschluss (Voraussichtlich)
1. August 2027
Studienanmeldedaten
Zuerst eingereicht
7. Juli 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. Juli 2021
Zuerst gepostet (Tatsächlich)
22. Juli 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
22. Juli 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
13. Juli 2021
Zuletzt verifiziert
1. Juli 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Shengjing-LCG008
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Brustkrebs
-
Novartis PharmaceuticalsAbgeschlossenMetastasierter Brustkrebs (MBC) | Locally Advance Breast Cancer (LABC)Vereinigtes Königreich, Spanien
-
BioNTech SESeventh Framework ProgrammeAbgeschlossenBrustkrebs (Triple Negative Breast Cancer (TNBC))Schweden, Deutschland
-
Filipa Lynce, MDAstraZeneca; Daiichi Sankyo, Inc.RekrutierungBrustkrebs | HER2-positiver Brustkrebs | Invasiver Brustkrebs | Entzündlicher Brustkrebs Stadium III | HER2 Low Breast AdenokarzinomVereinigte Staaten
Klinische Studien zur Pyrotinib
-
Hunan Cancer HospitalJiangsu HengRui Medicine Co., Ltd.Noch keine RekrutierungHER2-positiver BrustkrebsChina
-
Jiangsu HengRui Medicine Co., Ltd.Cancer Institute and Hospital, Chinese Academy of Medical SciencesAbgeschlossen
-
Peking Union Medical CollegeUnbekanntBrustkrebs | HER2-GenmutationChina
-
Tongji UniversityUnbekanntNicht-kleinzelligem LungenkrebsChina
-
Tianjin Medical University Cancer Institute and...UnbekanntNicht-kleinzelligem LungenkrebsChina
-
Henan Cancer HospitalJiangsu HengRui Medicine Co., Ltd.Aktiv, nicht rekrutierend
-
Jiangsu HengRui Medicine Co., Ltd.UnbekanntNicht kleinzellige LungeChina
-
RemeGen Co., Ltd.Noch keine RekrutierungNicht-kleinzelligem LungenkrebsChina
-
The First Affiliated Hospital with Nanjing Medical...First Affiliated Hospital of Wenzhou Medical UniversityRekrutierung
-
Second Affiliated Hospital, School of Medicine,...Zhejiang Cancer Hospital; First Affiliated Hospital of Zhejiang University; Sir... und andere MitarbeiterUnbekannt