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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05165225
Recruitment Status : Active, not recruiting
First Posted : December 21, 2021
Last Update Posted : November 15, 2023
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Chang Gong, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer HER2-low-expressing Breast Cancer Hormone Receptor-positive Breast Cancer Neoadjuvant Therapy Drug: Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 13, 2021
Actual Primary Completion Date : September 30, 2023
Estimated Study Completion Date : March 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pyrotinib
Experimental: Patients will receive Pyrotinib combined with Epirubicin and Cyclophosphamide followed by Docetaxel
 Drug: Pyrotinib + 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


Outcome Measures
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Primary Outcome Measures :
  1. Residual cancer burden 0/1 (RCB-0/1) rate [ Time Frame: within 6 weeks after surgery ]
    The percentage of patients with RCB-0/1 after neoadjuvant therapy


Secondary Outcome Measures :
  1. Pathological complete response (pCR) rate [ Time Frame: within 6 weeks after surgery ]
    The percentage of patients with pCR (ypT0/is, ypN0) after neoadjuvant therapy

  2. Objective response rate (ORR) [ Time Frame: 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】

  3. Breast conservation rate. [ Time Frame: within 6 weeks after surgery ]
    The breast conservation rate after treatment.

  4. Disease-free Survival (DFS) [ Time Frame: 5 years ]
    The DFS is defined as the time from registration until any relapse, secondary malignancy, or death from any cause

  5. Overall Survival (OS). [ Time Frame: 5 years ]
    The OS is defined as the time from registration to death, irrespective of cause.

  6. Biomarkers [ Time Frame: 5 years ]
    Biomarkers: e.g. Tils

  7. Incidence of grade 3-5 diarrhea. [ Time Frame: before surgery ]
    Diarrhea were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05165225


Locations
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China, Guangdong
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Gong Chang, doctor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
More Information
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Responsible Party: Chang Gong, Chief physician, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT05165225    
Other Study ID Numbers: PILHLE-001
First Posted: December 21, 2021    Key Record Dates
Last Update Posted: November 15, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
 Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors