Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab

Metastatic Breast Cancer Clinical Trial

Official title:

Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05346861
• Other study ID #: YBCSG-21-01
• Status: Recruiting
• Phase: Phase 3
• Start date: September 15, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, open-label, multi-center, parallel design study of the combination of pyrotinib, trastuzumab and chemotherapy versus trastuzumab and chemotherapy in HER2+ MBC patients, who have prior received trastuzumab and pyrotinib. Patients will be randomized in a 2:1 ratio to one of the following treatment arms. Arm A: pyrotinib + trastuzumab + chemotherapy, Arm B: trastuzumab + chemotherapy. Patients will receive either arm of therapy until disease progression, unacceptable toxicity, or withdrawal of consent.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Aged =18 and =75 years;

2. Pathologically confirmed HER2 positive patients with recurrence/ metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification;

3. History of trastuzumab-containing chemotherapy in neoadjuvant, adjuvant or recurrence/ metastatic setting;

4. History of pyrotinib-containing chemotherapy in neoadjuvant or recurrence/ metastatic setting;

5. Previously reveived =2 systemic treatment in recurrence/ metastasis setting; (anti-HER2 ADCs such as T-DM1 is included in chemotherapy regimens, endocrine therapy alone is not included);

6. ECOG performance status of 0 to 1;

7. According to RECIST 1.1, at least one extracranial measurable lesion exists;

8. Signed informed consent.

Exclusion Criteria:

1. Patients with leptomeningeal metastasis or unstable brain metastasis;

2. History of neurological or psychiatric disorders;

3. Second malignancies within 5 years, except for cured skin basal cell carcinoma, carcinoma in-situ of uterine cervix and squamous-cell carcinoma;

4. Undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or expected to undergo major surgery.

5. Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.);

6. History of allergies to the drug components of this regimen;

7. History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive), history of organ transplantation;

8. Any other situations judged by investigator as not suitable for participating in this study.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer
• Metastatic Breast Cancer

Intervention

Drug:
• Trastuzumab plus chemotherapy
Trastuzumab: 8 mg/kg loading dose followed by 6 mg/kg, Q3W Chemotherapy regimen is chosen from the following: Vinorelbine, Gemcitabine, taxanes or Eribulin monotherapy Experimental: Pyrotinib +Trastuzumab + chemotherapy
• Trastuzumab in combination with pyrotinib plus chemotherapy
Pyrotinib: 400 mg po QD, Q3W Chemotherapy regimen is chosen from the following: Vinorelbine, Gemcitabine, taxanes or Eribulin monotherapy

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)		approximately 8 months
Secondary	Objective Response Rate (ORR)		approximately 8 months
Secondary	Adverse Events (AEs)		From the first drug administration to within 28 days for the last treatment