Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer

Sun Yat-sen University

Status and phase

Enrolling

Phase 3

Conditions

Hormone-receptor-positive Breast Cancer

Early-stage Breast Cancer

Breast Cancer Invasive

HER2 Low Breast Carcinoma

Treatments

Drug: Epirubicin or doxorubicin, cyclophosphamide, paclitaxel

Drug: Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06144944

PILHLE-002

Details and patient eligibility

About

This is a multi-center, open-lable, prospective, randomized phase III clinical trial to further validate the efficacy and safety of neoadjuvant pyrotinib combined with chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative) high-risk early breast cancer

Enrollment

160 estimated patients

Sex

All

Ages

17 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must participate voluntarily, sign the informed consent form, and have good compliance
Aged ≥ 18 and ≤ 70 years old with ECOG PS score of 0-1
Histopathological newly diagnosed, unilateral, primary invasive breast cancer
Histopathological hormone receptor-positve ( estrogen receptor and/or progesterone receptor ≥ 10% stained cells) and HER2-low (immunochemistry 2+ with fluorescent in situ hybridization negative)
TNM stage-IIb/III, or TNM stage-IIa with high risk (N+, G3, or MammaPrint High-risk)
At least one evaluable target breast lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Left ventricular ejection fraction ≥ 55%, Fridericia-corrected QT interval < 450 ms in males and < 470 ms in females
White blood cell count: ≥ 3.0 × 10^9/L, absolute neutrophil count: ≥ 1.5 × 10^9/L, platelet count: ≥ 100 × 10^9/L, hemoglobin: ≥ 90 g/L
Aspartate aminotransferase and alanine aminotransferase: ≤ 2.5 × ULN, alkaline phosphatase: ≤ 2.5 × ULN, blood total bilirubin: ≤ 1.5 × ULN, serum creatinine: ≤ 1.5 × ULN
Non-menopausal or non-surgically sterilized female patients identified as non-pregnant and non-lactating and consented to contraception both during the trial and within 6 months after the last administration of the test drug

Exclusion criteria

Metastatic BC, bilateral BC, occult BC, inflammatory BC, or with other malignant tumors
Known history of hypersensitivity to the study drugs
Patients who need receive other anti-tumor treatments (except for OFS) during neoadjuvant therapy as judged by the investigators
With severe cardiac disease or discomfort that is not expected to tolerate treatment, including but not limited to: a) arrhythmia that requires medication or is clinically significant, or high-grade atrioventricular block, b) unstable angina, myocardial infarction, heart failure or clinically significant heart valve disease, c) poorly controlled hypertension or any heart disease unsuitable for participation in this trial as determined by the investigators
Patients who participated in a clinical trial of another drug within 4 weeks prior to randomization or underwent BC-free surgery within 4 weeks or had not fully recovered after BC-free surgery
Other malignancy in the past 5 years, other than cured cervical carcinoma in situ, basal or squamous cell carcinoma of skin
Patients who had basic gastrointestinal diseases (especially long-term history of diarrhea or/and constipation), inability to swallow, intestinal obstruction or other factors will affect drugs administration and absorption
Presence of accompanying diseases that may pose serious risks to the safety of the patient or may affect the patient's ability to complete the study (including but not limited to severe diabetes mellitus, active infection, thyroid disorders, etc.) as judged by the investigator
With a history of immunodeficiency, including acquired or congenital immunodeficiencies, or a history of organ transplantation
Past history of confirmed neurological or mental disorders, including epilepsy or dementia
Other conditions of the subject determined by the investigator to be unsuitable for the study