Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer

NCT04246502 | Unknown Phase 2

• 1 other identifier: Shandong CHI-11
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, multicenter phase 2 clinical trial to evaluate the efficacy and safety of capecitabine plus pyrotinib versus capecitabine plus trastuzumab plus pertuzumab in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Approximately 42 months

Secondary Outcomes (5)

• Adverse Events and Serious Adverse Events

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

• Overall Survival

  Up to 2 years

• Objective Response Rate

  Approximately 42 months

• Duration of Objective Response

  Approximately 42 months

• Clinical Benefit rate

  From the start of randomization to 6 months

Study Arms (2)

A

EXPERIMENTAL

Drug: Capecitabine and Pyrotinib

B

ACTIVE COMPARATOR

Drug: Capecitabine,Trastuzumab, and Pertuzumab

Interventions

Capecitabine and Pyrotinib DRUG

Pyrotinib 400mg orally daily until progressive disease

A

Capecitabine,Trastuzumab, and Pertuzumab DRUG

as instruction

B

Eligibility Criteria

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

You may qualify if:

• HER2 positive recurrent or metastasis breast cancer.
• Patients with measurable disease are eligible.
• Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
• Adequate organ function.
• Signed, written inform consent obtained prior to any study procedure.

You may not qualify if:

• History of anti-cancer therapy for MBC（with the exception of one prior hormonal regimen for MBC）.
• History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab used in the neo-adjuvant or adjuvant setting.
• Assessed by the investigator to be unable receive systemic chemotherapy.
• History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
• Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; pyrotinib; Trastuzumab; pertuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shandong Breast Disease Centre

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 29, 2020
• Study Start: January 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2024
• Last Updated: February 5, 2020

Record last verified: 2020-01