Phase II Neoadjuvant Pyrotinib Combined with Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial

Sun Yat-sen University

Status and phase

Active, not recruiting

Phase 2

Conditions

Breast Cancer

Hormone Receptor-positive Breast Cancer

HER2-low-expressing Breast Cancer

Neoadjuvant Therapy

Treatments

Drug: Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05165225

PILHLE-001

Details and patient eligibility

About

This is a single-arm, prospective, non-randomized, single-center, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib combined with epirubicin and cyclophosphamide followed by docetaxel in HR positive and HER2-low-expressing early or locally advanced breast cancer.

Enrollment

48 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures
Female patients, age ≥ 18 years
Histologically confirmed unilateral primary carcinoma of the breast, except for occult breast cancer, inflammatory breast cancer without assessable focus or eczema like breast cancer
HER2-low-positive (defined here as HER2 IHC 2+ and FISH-) and HR positive(defined here as ER and/or PR >1% stained cells)
Tumour greater than 2 cm diameter or histologically (core- or fine-needle biopsy) involved lymph nodes
According to RECIST version 1.1, there is at least one evaluable target lesion
Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
Required laboratory values including following parameters: WBC count:≥3.0 x 10^9/L ; ANC: ≥ 1.5 x 10^9/L; Platelet count: ≥ 100 x 10^9/L; Hemoglobin: ≥ 9.0 g/dL; Total bilirubin: ≤ 1.5 x upper limit of normal (ULN); ALT and AST: ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5 × ULN; Serum creatinine: ≤ 1.5 × ULN; Left ventricular ejection fraction (LVEF) ≥ 55%
For female patients without menopause or surgical sterilization: consent to contraception both during the trial and within 6 months after the last administration of the test drug

Exclusion criteria

Metastatic disease (Stage IV) or bilateral breast cancer
Known history of hypersensitivity to pyrotinib or any of it components
According to the judgment of the researcher, other anti-tumor treatments (except for ovarian function inhibitors) are required during neoadjuvant therapy
Patients with severe heart disease or discomfort who are expected to be unable to tolerate chemotherapy, including but not limited to these: 1). Fatal arrhythmia or higher grade atrioventricular block (second degree type 2 atrioventricular block or third degree atrioventricular block) 2). Unstable angina pectoris 3). Heart valve disease with clinical significance 4). ECG showed transmural myocardial infarction pain 5). Poor control of hypertension
Patients underwent major breast cancer-free surgery within 4 weeks or have not fully recovered
Serious or uncontrolled infections that may affect study treatment or evaluation of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, lung infection, etc
History of other malignant tumors in the past 5 years (excluding cured carcinoma in situ of cervix or skin basal cell carcinoma)
Those with basic gastrointestinal diseases (especially long-term history of diarrhea or/and constipation)；Inability to swallow、intestinal obstruction or other factors will affect drug administration and absorption
The investigator believes that the patient has any other conditions that are not suitable for participation in the study