Clinical Trials List
Protocol NumberODO-TE-B301
NCT Number(ClinicalTrials.gov Identfier)NCT03326674
2018-01-01 - 2022-12-31
Phase III
Terminated7
ICD-10C50
Malignant neoplasm of breast
A Multinational, Multicenter, Randomized, Phase 3 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
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Trial Applicant
STATPLUS, INC.
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Sponsor
Odonate Therapeutics, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Ya-Ping Chen Division of Hematology & Oncology
- Wu-Chou Su Division of Hematology & Oncology
- Jui-Hung Tsai Division of Hematology & Oncology
- Ya-Ting Hsu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Yi-Fang Tsai Division of General Surgery
- 金光亮 Division of General Surgery
- Ling-Ming Tseng Division of General Surgery
- 陳瑞裕 Division of General Surgery
- Chun-Yu Liu Division of Hematology & Oncology
- 林燕淑 Division of General Surgery
The Actual Total Number of Participants Enrolled
2 Stop recruiting
Audit
None
Linkou Chang Gung Medical Foundation
Taiwan National PI
陳訓徹
Co-Principal Investigator
- 沈士哲 Division of General Surgery
- Chia-Hui Chu Division of General Surgery
- Wen-Ling Kuo Division of General Surgery
- 張潤忠 Division of General Surgery
- 周旭桓 Division of General Surgery
- Wen-Chi Shen Division of General Surgery
- Chi-Chang Yu Division of General Surgery
- Yung-Chang Lin Division of General Surgery
The Actual Total Number of Participants Enrolled
2 Stop recruiting
Audit
None
Co-Principal Investigator
- Wei-Wu Chen Division of Hematology & Oncology
- MING-YANG WANG Division of General Surgery
- 張端瑩 Division of Hematology & Oncology
- 林季宏 Division of Hematology & Oncology
- 陳怡君 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane
Objectives
Primary:
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
Secondary:
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
Exploratory:
To investigate the pharmacokinetics (PK) of tesetaxel in patients with HER2 negative, HR positive
MBC previously treated with a taxane in the neoadjuvant or adjuvant setting
Test Drug
Tesetaxel
Active Ingredient
Tesetaxel
Dosage Form
capsule
Dosage
5, 20
Endpoints
Primary Efficacy Endpoint:
PFS as assessed by the IRC
Secondary Efficacy Endpoints (in order of importance):
OS
Objective response rate (ORR) as assessed by the IRC
Disease control rate (DCR) as assessed by the IRC
Patient-Reported Outcome Endpoints:
European Organisation for Research and Treatment of Cancer Quality of Life QuestionnaireC30 (EORTC QLQ-C30) Global Health Status/QoL
EORTC QLQ-C30 Functional Scales and Symptom Scales/Items
Safety Endpoints:
Adverse events (AEs), including deaths and other serious adverse events (SAEs)
Clinical laboratory abnormalities
Exploratory Endpoint:
Tesetaxel PK and its association with efficacy and safety endpoints
PFS as assessed by the IRC
Secondary Efficacy Endpoints (in order of importance):
OS
Objective response rate (ORR) as assessed by the IRC
Disease control rate (DCR) as assessed by the IRC
Patient-Reported Outcome Endpoints:
European Organisation for Research and Treatment of Cancer Quality of Life QuestionnaireC30 (EORTC QLQ-C30) Global Health Status/QoL
EORTC QLQ-C30 Functional Scales and Symptom Scales/Items
Safety Endpoints:
Adverse events (AEs), including deaths and other serious adverse events (SAEs)
Clinical laboratory abnormalities
Exploratory Endpoint:
Tesetaxel PK and its association with efficacy and safety endpoints
Inclution Criteria
Inclusion Criteria:
1. Female or male 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 boneonly 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
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). Any targeted therapies
approved for HER2 negative, HR positive MBC, including everolimus, are permitted as prior
therapy. There is no limit to the number of prior endocrine therapies.
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 and 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 Study treatment.
Acceptable methods include male/female condoms with spermicide, or vasectomy with medical
confirmation of surgical success
17. Written informed consent and authorization to use and disclose health information
18. Ability to comprehend and comply with the requirements of the Study
1. Female or male 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 boneonly 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
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). Any targeted therapies
approved for HER2 negative, HR positive MBC, including everolimus, are permitted as prior
therapy. There is no limit to the number of prior endocrine therapies.
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 and 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 Study treatment.
Acceptable methods include male/female condoms with spermicide, or vasectomy with medical
confirmation of surgical success
17. Written informed consent and authorization to use and disclose health information
18. Ability to comprehend and comply with the requirements of the Study
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)
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
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)
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
The Estimated Number of Participants
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Taiwan
26 participants
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Global
600 participants
