Efficacy and Safety of Inetetamab Plus Pyrotiniband and Capecitabine in HER2-positive Metastatic Breast Cancer Patients With or Without Brain Metastasis

NCT06015100 | Unknown

• 1 other identifier: CORP-239-Ｎ3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to include HER2-positive metastatic breast cancer patients (with or without brain metastasis) who have become resistant to previous treatment with trastuzumab. It will use pertuzumab in combination with pyrotinib and capecitabine to observe efficacy and safety. The choice of capecitabine as the chemotherapy drug is mainly based on the following reasons: ① it has been less commonly used as neoadjuvant treatment, making it less prone to cross-resistance; ② its oral formulation is convenient for administration, making it more acceptable to patients; ③ previous studies have shown good efficacy when combined with pyrotinib; ④ previous research in breast cancer patients with brain metastasis has also demonstrated certain effectiveness. It is hoped that through this study, preliminary evidence can be provided for the dual-target treatment of original Chinese drugs, as well as the treatment of HER2+ MBC after resistance to trastuzumab, and the addition of new data for patients with brain metastasis.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  It is an indicator of the long-term efficacy of the drug

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcomes (3)

• Objective Response Rate

  4 weeks

• Disease Control Rate

  4 weeks

• Overall survival

  the time from randomization to death from any cause, assessed up to 100 months.

Study Arms (1)

Label 1

EXPERIMENTAL

Inetetamab plus pyrotiniband and capecitabine

Drug: Inetetamab plus pyrotiniband and capecitabine

Interventions

Inetetamab plus pyrotiniband and capecitabine DRUG

Inetetamab plus pyrotiniband and capecitabine

Label 1

Eligibility Criteria

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

You may qualify if:

• Patients who can voluntarily sign an informed consent form;
• Females aged ≥18 years at the time of signing the informed consent form;
• ECOG PS performance status score between 0 and 2;
• Patients histologically diagnosed with HER2-positive metastatic breast cancer, with or without brain metastasis, and with locally recurrent disease that cannot undergo curative surgery or radiation therapy;
• Patients who experience relapse or metastasis within 1 year during or after (neo)adjuvant pertuzumab-based targeted therapy, or disease progression during first-line pertuzumab-based targeted therapy in advanced stages;
• Patients who have received ≤1 regimen of previous pertuzumab-based targeted therapy for recurrent or metastatic disease;
• Brain metastasis patients must meet the following criteria: stable previous brain metastasis treatment, untreated brain metastasis with no immediate need for local treatment, or progressive previous brain metastasis without immediate need for local treatment;
• Left ventricular ejection fraction (LVEF) ≥50%;
• Blood routine examination meets the following conditions: ① absolute neutrophil count (ANC) ≥1.5×109/L, ② platelet count ≥100×109/L, ③ hemoglobin ≥90g/L, ④ white blood cell count ≥3.0×109/L;
• Liver function meets the following conditions: ① serum total bilirubin ≤1.5×ULN, or ≤3×ULN if liver metastasis is present, ② aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3×ULN, or ≤5×ULN if liver metastasis is present;
• Renal function meets the following conditions: serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (creatinine clearance calculated according to the Cockcroft-Gault formula);
• Female patients who meet the following conditions can participate in this study: ① not fertile; ② fertility potential, with a negative pregnancy test result within 7 days before the first administration of the study drug, not breastfeeding, and consistently using highly effective contraceptive measures before study enrollment, throughout the study period, and within 6 months after the last administration of the study drug.

You may not qualify if:

• Those who have previously received Inetetamab and/or pyrotinib treatment;
• Those who have received capecitabine treatment within the past 2 weeks before randomization;
• Patients with noticeable symptoms who require immediate local treatment for brain metastasis;
• Known allergy to the drugs and excipients involved in this trial;
• Known history of hypersensitivity reactions to any investigational drug;
• Subjects deemed unfit for participation by other researchers.

Sponsors & Collaborators

• Yan Xue: lead

Study Sites (1)

Xi'an International Medical Center Hospital

Xi'an, Shaanxi, 710100, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

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

Study Officials

• Yan Xue

  Xi'an International Medical Center Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of tumor hospital

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 29, 2023
• Study Start: February 20, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)