- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04900311
Pyrotinib Versus Pertuzumab in Combination With Neoadjuvant Trastuzumab and Nab-Paclitaxel in HER2+ Early or Locally Advanced Breast Cancer (Pyramid)
19 maggio 2021 aggiornato da: Tianjin Medical University Cancer Institute and Hospital
The study is being conducted to evaluate the efficacy, and safety of pyrotinib versus pertuzumab in combination with trastuzumab and nab-paclitaxel for neoadjuvant treatment in HER2+ early or locally advanced breast cancer patients.
To explore whether pyrotinib regimen could provide better clinical results compared with pertuzumab in the study population.
Panoramica dello studio
Stato
Non ancora reclutamento
Intervento / Trattamento
Descrizione dettagliata
This study is a multi-center, randomized, open-label, controlled trial.
Eligible patients will be randomized to neoadjuvant pyrotinib or pertuzumab containing regimen every 3 weeks for four cycles before surgery.
Randomization was stratified by the following factors: hormone receptor status and primary tumor size.
After completing four cycles of neoadjuvant treatment, all patients who are eligible for surgery will undergo surgery and have their pathologic response evaluated.
Following surgery, patients will receive 90-100 mg/m2 epirubicin and 600 mg/m2 cyclophosphamide every 3 weeks for 4 cycles.
Clinicians will select subsequent treatments for patients based on guidelines as well as clinical practice at each site.
Tipo di studio
Interventistico
Iscrizione (Anticipato)
490
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Jin Zhang, MD, Professor
- Numero di telefono: 2121 0086-22-23340123
- Email: zhangjin@tjmuch.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 75 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
Inclusion Criteria:
- female patients, treatment-naïve, aged ≥ 18 years and ≤ 75 years;
- ECOG score 0-1 (ECOG, Eastern Cooperative Oncology Group);
- Histologically confirmed invasive breast cancer (early stage or locally advanced) :Primary tumor greater than 2 cm diameter and cT2-cT4/cN0-cN3/cM0 (clinical stage II and III);
- HER2 expression positive breast cancer confirmed by pathological examination,
- known hormone receptor status (ER and PR);
- the level of major organ function must meet the following requirements: blood routine test: neutrophil (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L; hemoglobin (Hb) ≥ 90g/L; blood biochemistry test: total bilirubin (TBIL) ≤ 2.5 × ULN (upper normal limit); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; echocardiography: LVEF ((Left Ventricular Ejection Fraction) ≥ 55%; 12 ECG: QT interval corrected by Fridericia method (QTcF) < 470 ms in women
- Female subjects who have not yet experienced menopausal or not surgically sterile agree to practice abstinence or use effective methods of contraception for at least 7 months during and after the last dose of study drug;
- Sign the informed consent form and are willing to cooperate in the follow-up.
Exclusion Criteria:
- breast cancer of both sides, stage IV breast cancer or metastatic breast cancer;
- inflammatory breast cancer;
- History of other malignancy, or previous anti-cancer therapy or radiotherapy for any malignancy, excluding cured carcinoma in situ of the cervix or squamous or basal cell carcinoma.
- simultaneously participated in other clinical trials;
- Major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or from which the patient has not fully recovered
- blood transfusion, or received colony-stimulating factor treatments before randomization;
- known history of allergy to any of the study medications and any of the ingredients or excipients of these medications;
- history of immunodeficiency, including positive HIV test, or suffering from other acquired, congenital immunodeficiency diseases, or history of organ transplantation.
- had any heart disease, including: (1) angina pectoris; (2) arrhythmia that is clinically significant or required medication; (3) myocardial infarction; (4) heart failure; (5) any other heart disease judged by the investigator as not suitable for this trial.
- pregnant or lactating
- Other concurrent serious diseases that are serious hazards to the patient's safety or may interfere with planned treatment (including but not limited to hypertension, severe diabetes, active infection, thyroid disease, etc.) ;
- Inability to swallow, chronic diarrhea, bowel obstruction, and other factors affecting medication intake and absorption.
- Any other condition that, in the opinion of the investigator, makes the subject unsuitable for this study.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: pyrotinib + trastuzumab + nab-paclitaxel
|
patients will be treated every 3 weeks for four cycles prior to surgery at following doses: pyrotinib: 400 mg/day, orally, qd trastuzumab: IV infusion on Day 1 every 3 weeks with loading dose of 8 mg/kg in Cycle 1, and 6 mg/kg in Cycles 2-4 nab-paclitaxel: 260 mg/m2 IV infusion on Day 1 every 3 weeks, or 125 mg/m2 IV infusion on Days 1, 8 and 15 every 3 weeks (the nab-paclitaxel administration cycle was determined by investigator at each site)
|
Comparatore attivo: pertuzumab + trastuzumab + nab-paclitaxel
|
patients will be treated every 3 weeks for four cycles prior to surgery at following doses: pertuzumab: IV infusion on Day 1 every 3 weeks with loading dose of 840 mg for Cycle 1, followed by 420 mg for Cycles 2-4 trastuzumab: IV infusion on Day 1 every 3 weeks with loading dose of 8 mg/kg in Cycle 1, and 6 mg/kg in Cycles 2-4 nab-paclitaxel: 260 mg/m2 IV infusion on Day 1 every 3 weeks, or 125 mg/m2 IV infusion on Days 1, 8 and 15 every 3 weeks (the nab-paclitaxel administration cycle was determined by investigator at each site)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
tpCR (totally pathological Complete Response) assessed by the IRC(Independent Review Committee)
Lasso di tempo: Pathologic response will be evaluated right after surgery, which will be performed within 14 days after the completion neoadjuvant therapy (four cycles, 21 days per cycle).
|
defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of neoadjuvant therapy and surgery.
|
Pathologic response will be evaluated right after surgery, which will be performed within 14 days after the completion neoadjuvant therapy (four cycles, 21 days per cycle).
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
iDFS (Invasive disease-free survival)
Lasso di tempo: from the date of surgery till two years after study-defined treatment.
|
iDFS, defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of one of the following events:
|
from the date of surgery till two years after study-defined treatment.
|
EFS (event free survival)
Lasso di tempo: from the date of surgery till two years after study-defined treatment.
|
EFS, defined as time from randomization to the first documentation of one of the following events:
|
from the date of surgery till two years after study-defined treatment.
|
ORR (Objective Response Rate)
Lasso di tempo: At the end of neoadjuvant therapy (four cycles, 21 days per cycle).
|
the proportion of patients who achieved Complete Response (CR) or Partial Response (PR) during Cycles 1-4, according to RECIST v1.1
|
At the end of neoadjuvant therapy (four cycles, 21 days per cycle).
|
the rate of adopting breast-conserving surgery
Lasso di tempo: evaluated right after surgery, which will be performed within 14 days after the completion neoadjuvant therapy (four cycles, 21 days per cycle).
|
the proportion of patients who have undergone breast-conserving surgery
|
evaluated right after surgery, which will be performed within 14 days after the completion neoadjuvant therapy (four cycles, 21 days per cycle).
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Incidence of serious adverse events and other adverse events of special interest
Lasso di tempo: through study completion, an average of 2.5 years.
|
Assess the incidence of serious adverse events (SAEs) and other adverse events.
|
through study completion, an average of 2.5 years.
|
Exploratory biomarker analyses
Lasso di tempo: through study completion, an average of 2.5 years.
|
The correlation between baseline molecular biomarkers and efficacy outcomes will be evaluated.
Biomarkers may include blood lipids and metabolomics profiles based on Nuclear Magnetic Resonance techniques.
|
through study completion, an average of 2.5 years.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Anticipato)
1 maggio 2021
Completamento primario (Anticipato)
1 dicembre 2023
Completamento dello studio (Anticipato)
1 dicembre 2025
Date di iscrizione allo studio
Primo inviato
28 aprile 2021
Primo inviato che soddisfa i criteri di controllo qualità
19 maggio 2021
Primo Inserito (Effettivo)
25 maggio 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 maggio 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
19 maggio 2021
Ultimo verificato
1 aprile 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie della pelle
- Neoplasie
- Neoplasie per sede
- Malattie del seno
- Neoplasie mammarie
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Agenti antineoplastici, fitogenici
- Agenti antineoplastici, immunologici
- Paclitaxel
- Trastuzumab
- Paclitaxel legato all'albumina
- Pertuzumab
Altri numeri di identificazione dello studio
- MA-BC-II-020
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
Sì
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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