Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer
A Prospective, Open-label,Multicenter Phase II Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Chemotherapy in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The investigators hypothesized that the experimental group (Pyrotinib+Trastuzumab+Docetaxel+ Carboplatin) could have a higher Pathological Complete Response (pCR) rate than the control group (Trastuzumab+Docetaxel+ Carboplatin) in neoadjuvant chemotherapy.
It is proposed that 268 participants will be enrolled in this study. The target population is women with early breast cancer (stage of T2-3N0-3M0) who are eligible for primary systemic therapy.
The primary objective of the trial is to determine the pCR rate. The secondary objective of the trial is to determine the Event-free survival(EFS), Disease-free Survival (DFS), Distance Disease-free Survival (DDFS), Objective Response Rate (ORR) rate.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- female patients, 18 years ≤ age ≤75 years；
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
- Histologically confirmed invasive breast cancer（early stage or locally advanced）
- HER2 positive (HER2+++ by IHC or FISH+)
- Known hormone receptor status.
- Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
- Signed informed consent form (ICF)
Exclusion Criteria:
- Metastatic disease (Stage IV) or inflammatory breast cancer.
- Previous or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix.
- Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- Unable or unwilling to swallow tablets.
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 |
|---|---|
|
Eksperimentel: Pyrotinib+Trastuzumab+Docetaxel+Carboplatin
|
Drug: Pyrotinib Pyrotinib: 400mg orally daily Drug: Trastuzumab Trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles; Drug: Docetaxel Docetaxel: 75mg/m2 for a total of 6 cycles Drug: Carboplatin Carboplatin: AUC=5 or 6 for a total of 6 cycles |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage of Participants With Pathological Complete Response (pCR)
Tidsramme: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Event-free survival
Tidsramme: Following surgery until Year 3
|
Following surgery until Year 3
|
|
Disease-free Survival
Tidsramme: Following surgery until Year 3
|
Following surgery until Year 3
|
|
Distance Disease-free Survival
Tidsramme: Following surgery until Year 3
|
Following surgery until Year 3
|
|
Objective Response Rate
Tidsramme: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery) up to approximately 12 months
|
Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery) up to approximately 12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Yu Zhigang, DR., The Second Hospital of Shandong University
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
Andre undersøgelses-id-numre
- 495573096
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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