Tesetaxel as First-line Therapy for Metastatic Breast Cancer

Study Overview
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Brief Summary
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The intravenously administered taxane, paclitaxel, is one of the most commonly employed agents for the treatment of both localized and advanced breast cancer. Tesetaxel is an orally administered taxane that is in development as first- and second-line treatment for patients with advanced cancers. This study is being undertaken to determine the efficacy and safety of tesetaxel administered as first-line therapy to patients with metastatic breast cancer.

Official Title
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A Phase II Study of Tesetaxel as First-line Therapy for Subjects With Metastatic Breast Cancer

Conditions
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Breast Neoplasm

Intervention / Treatment
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* Drug: Tesetaxel once every 3 weeks
* Drug: Tesetaxel once weekly


Participation Criteria
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Eligibility Criteria
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Primary Inclusion Criteria: Female At least 18 years of age Histologically or cytologically confirmed adenocarcinoma of the breast Stage IV disease HER2 status negative Measurable disease (revised RECIST; Version 1.1) Eastern Cooperative Oncology Group performance status 0 or 1 Life expectancy of at least 3 months Chemotherapy naïve or 1 prior chemotherapy regimen in the adjuvant setting (Prior taxane-based adjuvant therapy allowed provided patient had a disease-free interval of at least 12 months after completing this adjuvant therapy) Prior hormonal therapy, aromatase inhibitor therapy, and immunotherapy allowed Prior radiotherapy in the adjuvant setting allowed provided that less than 25% of the bone marrow had been irradiated Adequate bone marrow, hepatic, and renal function, as specified in the protocol At least 4 weeks and recovery from effects of prior surgery, hormonal therapy, aromatase inhibitor therapy, immunotherapy, radiotherapy, or other therapy with an approved or investigational agent Ability to swallow an oral solid-dosage form of medication Primary Exclusion Criteria: Known metastasis to the central nervous system History of other malignancy within the last 5 years other than curatively treated basal and squamous cell carcinoma of the skin or carcinoma of the cervix in situ Significant medical disease other than Stage IV breast cancer Presence of neuropathy > Grade 1 (NCI CTC, Version 4.0) History of hypersensitivity to a taxane Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tesetaxel once every 3 weeks<br>Tesetaxel 27 mg/m2 orally once every 21 days for up to 12 months | Drug: Tesetaxel once every 3 weeks<br>* Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months<br>* Other names: DJ-927;|
| Experimental: Tesetaxel once weekly<br>Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks in a 28-day cycle for up to 12 months | Drug: Tesetaxel once weekly<br>* Tesetaxel capsules orally once every 7 days for 3 consecutive weeks in a 28-day cycle; duration of therapy not to exceed 12 months<br>* Other names: DJ-927;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (revised RECIST) | Proportion of patients with a confirmed complete or partial response | 12 months from date of first dose of study medication for last patient enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate | Proportion of patients with a confirmed complete or partial response of any duration or stable disease ≥ 3 months in duration | 12 months from date of first dose of study medication for last patient enrolled | 
| Progression-free rate | Proportion of patients without disease progression 6 months following the first dose of study medication | 6 months from date of first dose of study medication for last patient enrolled | 
| Durable response rate | Proportion of patients with a confirmed complete or partial response ≥ 6 months in duration | 12 months from date of first dose of study medication for last patient enrolled | 
| Duration of response | Date when response criteria are first met to the date when progression is first documented | 12 months from date of first dose of study medication for last patient enrolled | 
| Time to progression | Date of first dose of study medication to the date when progression is first documented | 12 months from date of first dose of study medication for last patient enrolled | 
| Adverse events | Incidence of adverse events | Up to 30 days after the last dose of study medication for a specific patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic breast cancer, First-line therapy, Tesetaxel, Oral taxane