Recruiting NCT05918328

Comparing the Efficacy of Nab-PH+Pyrrolitinib and TCbHP in the Neoadjuvant Treatment of HER2 Positive BC

Phase II Interventional Breast Cancer HER2-positive Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Albumin paclitaxel+trastuzumab+pyrrolitinib, Docetaxel+Carboplatin+trastuzumab+Parstuzumab.
Who it may be relevant to: Registry conditions: Breast Cancer, HER2-positive Breast Cancer. Basic parameters: 18 years — 65 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Non Inferior, Randomized Controlled Phase II Clinical Study Comparing the Efficacy of Nab-PH+Pyrrolitinib and TCbHP in the Neoadjuvant Treatment of HER2 Positive Breast Cancer

Overview

At present, the incidence rate of breast cancer has exceeded that of lung cancer, becoming the largest cancer in the world. HER2 overexpression breast cancer accounts for about 20%\~30% of all breast cancer patients. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Targeted therapy for HER2 protein is the core treatment of this type of breast cancer. Previous studies have confirmed that TKI drugs can reverse the resistance of large molecule monoclonal antibodies to a certain extent; Moreover, due to the complementarity of therapeutic targets, monoclonal antibodies are associated with TKI Drugs have synergistic effects. TCbHP is one of the preferred neoadjuvant chemotherapy schemes recommended by NCCN guidelines for HER2 positive breast cancer, but its incidence of adverse reactions such as vomiting, diarrhea, anemia, thrombocytopenia is significantly higher than that of the scheme without platinum. In the GeparOcto study and Geparsixto study, based on anthracycline+purple shirt+double target, the addition of carboplatin did not further improve the PCR rate of HER2 positive breast cancer neoadjuvant therapy. GeparSepto research showed that compared to the solvent based paclitaxel group, albumin paclitaxel increased the pCR rate by 8.2% and the IDFS by 7.3%. In the CA024 study, compared to docetaxel, albumin paclitaxel also significantly increased ORR and PFS. In the study by Lavasani SM et al., the neoadjuvant therapy of albumin paclitaxel combined with topiramate achieved a PCR rate of 64%. Therefore, we assume that the new adjuvant treatment scheme of Nab PH+pyrrolitinib can not be inferior to the efficacy of TCbHP, and has a lower incidence of adverse reactions, which may become a new adjuvant treatment option for HER2 positive breast cancer patients.

Detailed description

Interventions

Drug Albumin paclitaxel+trastuzumab+pyrrolitinib
albumin paclitaxel （260mg/㎡ every 3 weeks or 125mg/㎡ weekly）+trastuzumab (initial loading dose 8 mg/kg, sequential maintenance dose 6 mg/kg, once every 3 weeks)+pyrrolitinib (320mg, QD), 3 weeks as one cycle.
Drug Docetaxel+Carboplatin+trastuzumab+Parstuzumab
Docetaxel 75 mg/m2+carboplatin (AUC=6)+trastuzumab (initial loading dose 8 mg/kg, sequential maintenance dose 6 mg/kg)+patuzumab (initial loading dose 840mg, sequential maintenance dose 420 mg), one cycle every 21 days

Primary outcome measures

Pathological complete response rate (pCR rate) [Time frame: immediately after the intervention]

Secondary outcome measures (5)

Event-Free Survival (EFS) [Time frame: 5-10 years after surgery]
DFS [Time frame: 5-10 years after surgery]
Distant Disease Free Survival (DDFS) [Time frame: 5-10 years after surgery]
Objective Response Rate (ORR) [Time frame: Preoperative]
number of adverse events [Time frame: during each cycle of chemotherapy (21 days as 1 cycle)]

Eligibility criteria

Inclusion criteria

Age: 18-65 years old, ECOG 0-1 point.
Clinical T2-T4d, or T1c with axillary LN+.
HER2+, invasive breast cancer confirmed by histopathology;(HER2 positive expression means that there is at least one case of tumor cell immunohistochemical staining intensity of 3+or positive confirmed by fluorescence in situ hybridization \[FISH\] in the pathological test/review of the primary focus conducted by the Pathology Department of the Research Center Hospital).
Having clinically measurable lesions: measurable lesions displayed on ultrasound, mammography, or MR (optional) within the first month of randomization.
Organ and bone marrow function tests within one month before chemotherapy indicate no contraindications to chemotherapy:Absolute value of neutrophil count ≥ 2.0 × 109/L; Hemoglobin ≥ 90g/L; Platelet count ≥ 100 × 109/L;Total bilirubin<1.5 ULN (upper limit of normal value); Creatinine<1.5 × ULN; AST/ALT < 1.5 × ULN.
Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 55%).
Women of childbearing age tested negative for serum pregnancy test 14 days before randomization.
Sign an informed consent form.

Exclusion criteria

Stage IV (metastatic) breast cancer.
Has received chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. for this disease.
The patient has a second primary malignant tumor, except for fully treated skin cancer.
The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical procedures.
Serious heart disease or discomfort, including but not limited to the following diseases:Confirmed history of heart failure or systolic dysfunction (LVEF<50%); High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate>100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block; Angina pectoris requiring treatment with anti angina drugs; Clinically significant heart valve disease; ECG shows transmural myocardial infarction; Poor control of hypertension (systolic blood pressure>180 mmHg and/or diastolic blood pressure>100 mmHg).
Due to serious and uncontrollable other medical diseases, researchers believe that there are contraindications to chemotherapy.
Individuals with a known history of allergies to the drug components of this protocol; Having a history of immunodeficiency, including HIV testing positive, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

China · 1 center

Henan cancer hospital — Zhengzhou

Identifiers

NCT: NCT05918328 · HELEN-013

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗