Breast Cancer, HER2-low-expressing Breast Cancer, Hormone Receptor-positive Breast Cancer, Neoadjuvant Therapy
Conditions
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.
Interventions
DRUGPyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment
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
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures 2. Female patients, age ≥ 18 years 3. Histologically confirmed unilateral primary carcinoma of the breast, except for occult breast cancer, inflammatory breast cancer without assessable focus or eczema like breast cancer 4. HER2-low-positive (defined here as HER2 IHC 2+ and FISH-) and HR positive(defined here as ER and/or PR \>1% stained cells) 5. Tumour greater than 2 cm diameter or histologically (core- or fine-needle biopsy) involved lymph nodes 6. According to RECIST version 1.1, there is at least one evaluable target lesion 7. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 8. 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% 9. 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
1. Metastatic disease (Stage IV) or bilateral breast cancer 2. Known history of hypersensitivity to pyrotinib or any of it components 3. According to the judgment of the researcher, other anti-tumor treatments (except for ovarian function inhibitors) are required during neoadjuvant therapy 4. 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 5. Patients underwent major breast cancer-free surgery within 4 weeks or have not fully recovered 6. 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 7. History of other malignant tumors in the past 5 years (excluding cured carcinoma in situ of cervix or skin basal cell carcinoma) 8. 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 9. The investigator believes that the patient has any other conditions that are not suitable for participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual cancer burden 0/1 (RCB-0/1) rate | within 6 weeks after surgery | The percentage of patients with RCB-0/1 after neoadjuvant therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response (pCR) rate | within 6 weeks after surgery | The percentage of patients with pCR (ypT0/is, ypN0) after neoadjuvant therapy |
| Objective response rate (ORR) | within 6 weeks after surgery | The percentage of subjects with CR or PR as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of preoperative neoadjuvant therapy 【(CR+PR)/Analysis of the total number of people】 |
| Breast conservation rate. | within 6 weeks after surgery | The breast conservation rate after treatment. |
| Disease-free Survival (DFS) | 5 years | The DFS is defined as the time from registration until any relapse, secondary malignancy, or death from any cause |
| Overall Survival (OS). | 5 years | The OS is defined as the time from registration to death, irrespective of cause. |
| Biomarkers | 5 years | Biomarkers: e.g. Tils |
| Incidence of grade 3-5 diarrhea. | before surgery | Diarrhea were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORGong Chang, doctor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Outcome results
None listed