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

NCT05165225 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: PILHLE-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; HER2-low-expressing Breast Cancer; Hormone Receptor-positive Breast Cancer; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Residual cancer burden 0/1 (RCB-0/1) rate

  The percentage of patients with RCB-0/1 after neoadjuvant therapy

  within 6 weeks after surgery

Secondary Outcomes (7)

• Pathological complete response (pCR) rate

  within 6 weeks after surgery

• Objective response rate (ORR)

  within 6 weeks after surgery

• Breast conservation rate.

  within 6 weeks after surgery

• Disease-free Survival (DFS)

  5 years

• Overall Survival (OS).

  5 years

Study Arms (1)

Pyrotinib

EXPERIMENTAL

Experimental: Patients will receive Pyrotinib combined with Epirubicin and Cyclophosphamide followed by Docetaxel

Drug: Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment

Interventions

Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment DRUG

Drug: Pyrotinib pyrotinib 320mg orally daily Drug: Epirubicin epirubicin 90mg/m\^2 d1 iv Q3W for 4 cycles Drug: Cyclophosphamide cyclophosphamide 600mg/m\^2 d1 iv Q3W for 4 cycles Drug: Docetaxel docetaxel 100mg/m\^2 d1 iv Q3W for 4 cycles

Pyrotinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinib; Epirubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Gong - Chang, doctor

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: December 21, 2021
• Study Start: July 13, 2021
• Primary Completion: September 30, 2023
• Study Completion (Estimated): March 31, 2028
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)