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Odonate ODO-TE-0301 (CONTESSA): Randomized, phase III study of tesetaxel plus a reduced dose of capecitabine versus capecitabine alone in patients with HER2-negative, HR-positive, locally advanced or metastatic breast cancer previously treated with a taxane

Description

This is a multi-national, multi-center, randomized, open-label, parallel group phase III study. This study will compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival in patients with HER2-negative, HR-positive, locally advanced/metastatic breast cancer that was previously treated with a taxane in the neoadjuvant or adjuvant setting.

Status

Accepting new patients

Primary Study Objective(s)

 

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, locally advanced/metastatic breast cancer that was previously treated with a taxane in the neoadjuvant or adjuvant setting.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Are male or female and at least 18 years old
  • Have histologically or cytologically confirmed breast cancer
  • Have HER2-negative disease based on local testing guidelines by the American Society of Clinical Oncology (ASCO) or the College of American Pathologists (CAP) 
  • Have HR (ER and/or PgR)-positive disease based on local testing guidelines by ASCO or CAP
  • Have 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 may be accurately assessed by computerized tomography or magnetic resonance imaging. Patients with bone-only disease without a lytic component (i.e., blastic-only metastasis) are not eligible.
    • Known metastases to the central nervous system (CNS) are permitted but not required. The following criteria apply:
      • Patients must be neurologically stable and either off corticosteroids or currently treated with a maximum daily dose of 4 mg of dexamethasone (or equivalent), with no increase in corticosteroid dose within seven days prior to randomization.
      • Patients with a history of CNS metastases but with no current evidence of CNS lesions following local therapy are eligible.
      • Patients may have CNS metastases that are stable or progressing radiologically.
      • Patients with current evidence of leptomeningeal disease are not eligible.
      • Patients may have untreated brain metastases or previously treated brain metastases, as long as no immediate local CNS-directed therapy is indicated.
      • Any prior whole-brain radiation therapy must have been completed more than 14 days prior to the date of randomization.
      • Prior stereotactic brain radiosurgery is permitted.
      • CNS surgical resection must have been completed more than 28 days prior to the date of randomization; patient must completely recovered from surgery.
  • Have Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Have prior therapy (at least one completed dose) with a taxane-containing regimen in the neoadjuvant or adjuvant setting
  • Have prior therapy with an anthracycline-containing regimen in the neoadjuvant, adjuvant or metastatic setting, where indicated by local regulation or investigator judgment
  • Have prior endocrine therapy with or without a CDK 4/6 inhibitor unless endocrine therapy is not indicated (i.e., short, relapse-free interval while on adjuvant endocrine therapy (endocrine resistance), rapidly progressing disease or visceral crisis, or endocrine intolerance). Any targeted therapies approved for HER2-negative, HR-positive, locally advanced or metastatic breast cancer, including everolimus, are permitted as prior therapy. There is no limit to the number of prior endocrine therapies.
  • Have documented disease recurrence or disease progression of either locally advanced disease that is not considered curable by surgery and/or radiation, or metastatic disease
  • Have adequate hematologic, hepatic and renal function
  • Have had complete recovery to baseline or Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 from adverse effects of prior surgery, radiotherapy, endocrine therapy, and other therapy, as applicable, with the exception of Grade 2 alopecia from prior chemotherapy
  • Have the ability to swallow an oral, solid-dosage form of medication
  • Have had a negative serum pregnancy test within seven days prior to the first dose of study treatment in women of childbearing potential (i.e., all women except those who are post-menopausal for at least one year or who have a history of hysterectomy or surgical sterilization)
  • Are women of childbearing potential who use an effective, non-hormonal form of contraception from screening throughout the treatment phase and until 70 days after the last dose of study treatment
  • Are male patients who use an effective, non-hormonal form of contraception from screening throughout the treatment phase and until 130 days after last dose of study treatment
  • Have written, informed consent and authorization to use and disclose health information
  • Have the ability to comprehend and comply with the requirements of the study

Excluding patients who:

  • Have had two or more prior chemotherapy regimens for advanced disease
  • Have had prior treatment with a taxane in the metastatic setting
  • Have had prior treatment with capecitabine at any dose
  • Have current evidence of leptomeningeal disease
  • Have had other cancer that required therapy within the preceding five years that wasn't adequately treated, including non-melanoma skin cancer or in situ cancer, or other cancer that has a very low risk of interfering with the safety or efficacy endpoints of the study
  • Have a known human immunodeficiency virus infection, unless well controlled. Patients who are on an adequate anti-viral regimen with no evidence of active infection are considered well controlled.
  • Have active hepatitis B or active hepatitis C infection
  • Have 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
  • Have a presence of neuropathy that is greater than Grade 1 per NCI CTCAE version 5.0 
  • Have a history of hypersensitivity to taxanes, although hypersensitivity to the solvent does not preclude patient participation in this study
  • Have had an anti-cancer treatment, including endocrine therapy, radiotherapy (except stereotactic brain surgery), chemotherapy, biologic therapy or therapy in an investigational clinical study, 14 days or more prior to the date of randomization
  • Have had major surgery 28 days or more prior to the date of randomization; patient must have had complete recovery from surgery
  • Have had fewer than two weeks or five plasma half-lives (whichever is greater) since the last use of a medication or ingestion of an agent, beverage or food that is a known clinically relevant strong inhibitor or known clinically relevant inducer of the cytochrome P450 (CYP) 3A pathway (patients should discontinue taking any regularly taken medication that is a strong inhibitor or inducer of the CYP3A pathway)
  • Have a history of hypersensitivity or unexpected reactions to capecitabine, other fluoropyrimidine agents, or any of their ingredients
  • Have a known dihydropyrimidine dehydrogenase (DPD) deficiency. Testing for DPD deficiency must be performed where required by local regulations, using a validated method that is approved by local health authorities.
  • Are pregnant or breastfeeding
  • Are, in the opinion of the investigator, deemed unwilling or unable to comply with the requirements of the study
  • Have had treatment with brivudine, sorivudine or its chemically related analogs 28 days or more prior to the date of randomization

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