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Phase 1

• Conditions: Patients with Breast Cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002961-23-ES
• Lead Sponsor: Odonate Therapeutics, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-30
• Last Update Posted: 25 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified