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

NCT05346861 | Unknown Phase 3

• 1 other identifier: YBCSG-21-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HER2-positive Breast Cancer; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  approximately 8 months

Secondary Outcomes (2)

• Objective Response Rate (ORR)

  approximately 8 months

• Adverse Events (AEs)

  From the first drug administration to within 28 days for the last treatment

Study Arms (2)

Trastuzumab plus chemotherapy

ACTIVE COMPARATOR

Drug: Trastuzumab plus chemotherapy

Pyrotinib in combination with Trastuzumab plus chemotherapy

EXPERIMENTAL

Drug: Trastuzumab in combination with pyrotinib plus chemotherapy

Interventions

Trastuzumab plus chemotherapy DRUG

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 plus chemotherapy

Trastuzumab in combination with pyrotinib plus chemotherapy DRUG

Pyrotinib: 400 mg po QD, Q3W Chemotherapy regimen is chosen from the following: Vinorelbine, Gemcitabine, taxanes or Eribulin monotherapy

Pyrotinib in combination with Trastuzumab plus chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 and ≤75 years;
• Pathologically confirmed HER2 positive patients with recurrence/ metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification;
• History of trastuzumab-containing chemotherapy in neoadjuvant, adjuvant or recurrence/ metastatic setting;
• History of pyrotinib-containing chemotherapy in neoadjuvant or recurrence/ metastatic setting;
• 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);
• ECOG performance status of 0 to 1;
• According to RECIST 1.1, at least one extracranial measurable lesion exists；
• Signed informed consent.

You may not qualify if:

• Patients with leptomeningeal metastasis or unstable brain metastasis;
• History of neurological or psychiatric disorders;
• Second malignancies within 5 years, except for cured skin basal cell carcinoma, carcinoma in-situ of uterine cervix and squamous-cell carcinoma;
• Undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or expected to undergo major surgery.
• Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.);
• History of allergies to the drug components of this regimen;
• History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive), history of organ transplantation;
• Any other situations judged by investigator as not suitable for participating in this study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• Dai L, Gao T, Guo R, Chen Y, Wang J, Zhou S, Tang Y, Chen D, Huang S. Efficacy and safety of pyrotinib-based regimens in HER2 positive metastatic breast cancer: A retrospective real-world data study. Neoplasia. 2024 Oct;56:101029. doi: 10.1016/j.neo.2024.101029. Epub 2024 Jul 17.

  PMID: 39024777 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Drug Therapy; pyrotinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 26, 2022
• Study Start: September 15, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2024
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

CN (1)