A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country20 target enrollmentSeptember 8, 2022

ConditionsBreast Cancer

InterventionsPemigatinib Pill

DrugsPemigatinib Pill

Overview

Phase: Phase 2
Intervention: Pemigatinib Pill
Conditions: Breast Cancer
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 20
Locations: 1
Primary Endpoint: ORR
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a prospective single-arm phase II clinical study. HER2-negative advanced breast cancer patients with FGFR 1-3 alterations who have failed standard therapy will be enrolled in this study once they have signed the informed consent form (ICF) and been identified as eligible in screening. The patients will receive 13.5 mg of pemigatinib once a day (QD) orally following a 2-week administration/1-week interruption regimen. They will be dosed until disease progression or intolerable toxicity. During treatment, clinical tumor imaging evaluation will be performed according to RECIST v1.1 every 6 weeks (± 7 days) and then every 12 weeks (± 7 days) after week 48. Safety will be assessed according to NCI-CTCAE 5.0.

Registry

clinicaltrials.gov

Start Date

September 8, 2022

End Date

September 8, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Principal Investigator

Zhongsheng Tong

Chief physician

Tianjin Medical University Cancer Institute and Hospital

Eligibility Criteria

Inclusion Criteria

•Subjects must sign a written ICF prior to the implementation of any procedures related to the study;
•Aged ≥ 18 years old;
•With histologically confirmed locally advanced and/or metastatic breast cancer;
•With HER-2 negative (according to IHC or ISH test results, interpretation criteria was referred to 2020 CSCO Breast Cancer Diagnosis and Treatment guidelines), and
•① For metastatic patients with HR positive, they must have received endocrine therapy once before, and previous chemotherapy times ≤3 times
•② For patients with HR negative, 1 time ≤ times of previous chemotherapy ≤3 times
•Have at least one measurable lesion according to RECIST v1.1;
•With confirmed FGFR1-3 alterations, including but not limited to amplification, mutation, fusion/rearrangement, etc.;
•With disease progression after standard therapy, or no response to standard treatment, or no standard treatment options;
•ECOG physical performance status score of 0-1;

Exclusion Criteria

•Diagnosed with malignant tumors other than breast cancer within 5 years before the first dose, excluding radically cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ;
•Previously treated with selective FGFR inhibitors;
•Have received any other investigational drug treatment or participated in another interventional clinical trial within 28 days before the first dose of the investigational drug, or have received anti-tumor drug treatment within 28 days before the first dose of the investigational drug (including Chinese herbal medicine with anti-tumor indications);
•Have not recovered (i.e., reaching ≤ grade 1 or the baseline status, excluding asthenia and alopecia) from toxicity and/or complications caused by any intervention before the start of treatment;
•With known symptomatic central nervous system metastasis and/or carcinomatous meningitis. Subjects with previously treated brain metastases are eligible if the disease is stable (no imaging evidence of progression in at least 4 weeks prior to the first dose of study treatment), there is no evidence of new or enlarging brain metastases on repeated imaging, and corticosteroids are not required in at least 14 days prior to the first dose of study treatment. Patients with carcinomatous meningitis should be excluded regardless of their clinically stability;
•Pregnant or lactating;
•Known history of allotransplantation or allogeneic hematopoietic stem cell transplantation;
•Subjects with abnormal laboratory parameters listed below:
•① Serum phosphate \> ULN;
•② Serum calcium exceeds the normal range, or the calcium concentration corrected for serum albumin exceeds the normal range when serum albumin exceeds the normal range;