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

NCT05560334 | Unknown Phase 2

• 1 other identifier: CIBI375Y008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  ORR is defined as the proportion of subjects with complete response (CR) + those with partial response (PR) according to the RECIST1.1 criteria

  about 2 years

Study Arms (1)

Pemigatinib

EXPERIMENTAL

Selective FGFR1-3 inhibitor

Drug: Pemigatinib Pill

Interventions

Pemigatinib Pill DRUG

13.5mg, po, 2 weeks on/1 week off, Q3W

Also known as: Pemazyre

Pemigatinib

Eligibility Criteria

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

You may qualify if:

• 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;
• Expected survival time \> 3 months;
• For evidence of sufficient organ functions, the subjects shall meet the following laboratory parameters:
• ① Absolute neutrophil count (ANC) ≥ 1.5×109/L without use of granulocyte colony stimulating factor in recent 14 days;
• Platelet count ≥ 100×109/L without blood transfusion in recent 14 days;
• Hemoglobin \> 9 g/dL without blood transfusion or erythropoietin use in recent 14 days;

You may not qualify if:

• 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;
• ③ Potassium level \< lower limit of normal (LLN); potassium levels can be corrected by supplements at screening.
• With known history of human immunodeficiency virus (HIV) infection or confirmed with positive immune test results;
• Presence of severe infection in the active phase or with poor clinical control;
• Pleural effusion, ascites, or pericardial effusion with obvious clinical symptoms that require drainage;
• Acute or chronic active hepatitis B or C infection; hepatitis B virus (HBV) DNA \> 2000 IU/mL or 104 copies/mL; hepatitis C virus (HCV) RNA \> 103 copies/mL; hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive concurrently. Those who with relevant parameters lower than the above criteria after nucleotide antiviral treatment can be enrolled;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Breast Oncology, Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pemigatinib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhongsheng Tong, Doctor

CONTACT

18622221181; tongzhongsheng@tjmuch.com

Haotian Wang, Doctor

CONTACT

15510931687

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: September 8, 2022
• Primary Completion: September 8, 2024
• Study Completion: September 8, 2025
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

CN (1)