Patients with Breast Cancer
Conditions
Sponsors
Odonate Therapeutics, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria must be met: 1. Patients at least 18 years of age 2. Histologically or cytologically confirmed breast cancer 3. HER2 negative disease based on local testing: American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines should be utilized for assessing HER2 status. 4. HR (ER and/or PgR) positive disease based on local testing: ASCO/CAP guidelines should be utilized for assessing HR status. 5. Measurable disease per RECIST 1.1 or bone-only disease with lytic component. Patients with bone-only metastatic cancer must have a lytic or mixed lytic-blastic lesion that can be accurately assessed by computerized tomography (CT) or magnetic resonance imaging (MRI). Patients with bone-only disease without a lytic component (ie, blastic-only metastasis) are not eligible. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Appendix B) 7. Prior therapy with a taxane-containing regimen in the neoadjuvant or adjuvant setting 8. Prior therapy with an anthracycline-containing regimen in the neoadjuvant, adjuvant, or metastatic setting, where indicated 9. Prior endocrine therapy with or without a CDK 4/6 inhibitor unless endocrine therapy is not indicated (ie, short relapse-free interval while on adjuvant endocrine therapy [endocrine resistance]; rapidly progressing disease/visceral crisis; or endocrine intolerance) 10. Documented disease recurrence or disease progression 11. Adequate bone marrow, hepatic, and renal function, as evidenced by: ? Absolute neutrophil count (ANC) = 1,500/µL without colony-stimulating factor support ? Platelet count = 100,000/µL ? Hemoglobin = 10 g/dL without need for hematopoietic growth factor or transfusion support ? Total bilirubin < 1.5 × upper limit of normal (ULN); does not apply to patients with Gilbert’s syndrome ? Alanine aminotransferase (ALT) < 3 × ULN unless hepatic metastases are present then < 5 × ULN ? Aspartate aminotransferase (AST) < 3 × ULN unless hepatic metastases are present then < 5 × ULN ? Alkaline phosphatase < 2.5 × ULN unless hepatic metastases are present then < 5 × ULN ? Calculated creatinine clearance = 50 mL/min ? Serum albumin = 3.0 g/dL ? Prothrombin time (PT) < 1.5 × ULN or international normalized ratio (INR) < 1.3 and partial thromboplastin time (PTT) < 1.5 × ULN; does not apply to patients on a stable dose of anticoagulant 12. Complete recovery to baseline or Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 from adverse effects of prior surgery, radiotherapy, endocrine therapy, and other therapy, as applicable 13. Ability to swallow an oral solid-dosage form of medication 14. A negative serum pregnancy test within 7 days prior to the first dose of Study treatment in women of childbearing potential (ie, all women except those who are post menopause for = 1 year or who have a history of hysterectomy or surgical sterilization) 15. Women of childbearing potential must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase, until the End of Treatment visit. ? Acceptable methods include: copper intrauterine device or double barrier methods, including male/female condoms with spermicide and use of contraceptive sponge, cervical cap, or diaphragm. 16. Male patients must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase and until 90 days after last dose of Stu
Exclusion criteria
Exclusion criteria: 1. Two or more prior chemotherapy regimens for advanced disease 2. Prior treatment with a taxane in the metastatic setting 3. Prior treatment with capecitabine 4. Known metastases to the central nervous system 5. Other cancer that required therapy within the preceding 5 years other than adequately treated non-melanoma skin cancer or in situ cancer 6. Known human immunodeficiency virus infection unless well controlled. Patients who are on an adequate antiviral regimen with no evidence of active infection are considered well controlled 7. Active hepatitis B or active hepatitis C infection 8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Study participation or investigational product administration or may interfere with the interpretation of Study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this Study. 9. Presence of neuropathy > Grade 1 per NCI CTCAE version 4.03 10. History of hypersensitivity to taxanes; hypersensitivity to the solvent does not preclude patient participation in this Study 11. Anticancer treatment, including endocrine therapy, radiotherapy, chemotherapy, or biologic therapy, = 14 days prior to the date of Randomization 12. Major surgery = 28 days prior to the date of Randomization; patient must have complete recovery from surgery 13. Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the cytochrome P450 (CYP)3A or CYP2C9 pathways (patients should discontinue taking any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A or CYP2C9 pathways [refer to Appendix C]) 14. History of hypersensitivity to capecitabine, other fluoropyrimidine agents, or any of their ingredients 15. Known dihydropyrimidine dehydrogenase (DPD) deficiency 16. Pregnant or breastfeeding 17. If, in the opinion of the Investigator, the patient is deemed unwilling or unable to comply with the requirements of the Study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone in patients with HER2 negative, HR positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting.;Primary end point(s): The primary endpoint is Progression Free Survival (PFS) adjudicated by the Independent Radiologic Review Committee (IRC).;Timepoint(s) of evaluation of this end point: Progression Free Survival is defined as the time from randomization to the date of Disease Progression as adjudicated by IRC.;Secondary Objective: The secondary objective is to assess the safety and tolerability of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone in patients with HER2 negative, HR positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Patient-reported outcomes (PROs) will also be assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Overall Survival is defined as the time from randomization to death due to any cause. ORR and DCR are defined from the time of randomization to the time of response or disease control as adjudicated by the IRC.;Secondary end point(s): Secondary efficacy endpoints (in order of importance): ? Overall Survival (OS) ? Objective Response Rate (ORR) as assessed by the IRC ? Disease control rate (DCR) as assessed by the IRC Patient-reported outcome endpoints: ? EORTC QLQ-C30 Global Health Status/QoL ? EORTC QLQ-C30 Functional Scales and Symptom Scales/Items Safety endpoints: ? AEs, including deaths and other SAEs ? Clinical laboratory abnormalities | — |
Countries
Australia, Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Singapore, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States
Contacts
Public ContactVP of Regulatory Affairs
Odonate Therapeutics, LLC
Outcome results
None listed