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Antibody-Drug Conjugate
Dato-DXd for Breast Cancer (TB-01 Trial)
Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate organ and bone marrow function within 7 days before day of first dosing as follows: Hemoglobin: ≥ 9.0 g/L, Absolute neutrophil count: 1500/mm3, Platelet count: 100000/mm3, Total bilirubin: ≤ 1.5 × ULN if no liver metastases; or ≤ 3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline, ALT and AST: ≤ 3 × ULN for AST/ALT; however, if elevation is due to liver metastases, ≤ 5.0 × ULN is allowed, Calculated creatinine clearance: ≥ 30 mL/min as calculated using the Cockcroft-Gault equation (using actual body weight), LVEF ≥ 50% by either an echocardiogram or MUGA within 28 days of first dosing
At least 1 measurable lesion not previously irradiated that qualifies as a RECIST 1.1. Note: Participants with bone-only metastases are not permitted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to event up to 21 months; from date of first response until progression or death up to 20 months
Awards & highlights
TB-01 Trial Summary
This trial will compare the safety and effectiveness of Dato-DXd with standard chemotherapy for people with inoperable or metastatic breast cancer that is HR-positive and HER2-negative.
Who is the study for?
Adults with inoperable or metastatic HR-positive, HER2-negative breast cancer who have tried 1-2 chemotherapy lines and aren't suitable for endocrine therapy. They must be well enough (ECOG PS of 0 or 1), have adequate organ function, no severe heart conditions, controlled blood pressure, and not pregnant. Participants need a measurable lesion that's RECIST 1.1 compliant and can't have active brain metastases requiring steroids.Check my eligibility
What is being tested?
The trial is testing Dato-DXd against standard single-agent chemotherapies like eribulin, capecitabine, vinorelbine, or gemcitabine in patients with certain advanced breast cancers. It aims to see if Dato-DXd is safer or more effective compared to these existing treatments.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea, low blood cell counts increasing infection risk; potential liver enzyme changes; hair loss may occur due to chemotherapy agents.
TB-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood, liver, kidney, and heart functions meet the trial's requirements.
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I have a tumor that can be measured and hasn't been treated with radiation.
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I've had 1-2 chemotherapy treatments for my inoperable/metastatic cancer and it's still progressing.
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My breast cancer cannot be removed by surgery and is HR+ and HER2-.
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I am 18 years old or older.
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I am 18 years old or older.
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I am using birth control approved by this study's guidelines, not including oral estrogens.
TB-01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to event up to 21 months; from date of first response until progression or death up to 20 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to event up to 21 months; from date of first response until progression or death up to 20 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Progression Free Survival
Secondary outcome measures
Clinical Outcome Assessment- TTD in GHS
Clinical Outcome Assessment- TTD in pain
Clinical Outcome Assessment- TTD in physical Functioning
+9 moreTB-01 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dato-DXdExperimental Treatment1 Intervention
Arm 1: Dato-DXd
Group II: Investigators Choice of Chemotherapy (ICC)Active Control4 Interventions
Arm 2: ICC
Capecitabine
Gemcitabine
Eribulin mesylate
Vinorelbine
Find a Location
Who is running the clinical trial?
Daiichi SankyoIndustry Sponsor
396 Previous Clinical Trials
418,267 Total Patients Enrolled
25 Trials studying Breast Cancer
16,895 Patients Enrolled for Breast Cancer
AstraZenecaLead Sponsor
4,286 Previous Clinical Trials
288,619,318 Total Patients Enrolled
173 Trials studying Breast Cancer
1,245,613 Patients Enrolled for Breast Cancer
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
419,744 Total Patients Enrolled
27 Trials studying Breast Cancer
18,870 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself and have not gotten worse in the past 2 weeks.I do not have serious heart problems or very high blood pressure.I had cancer before, but it was treated over 3 years ago and is not likely to come back.My blood, liver, kidney, and heart functions meet the trial's requirements.I do not have active or uncontrolled hepatitis B or C.I have a tumor that can be measured and hasn't been treated with radiation.My cancer has worsened despite hormone therapy and I've had 1-2 chemotherapy treatments.Criterion: You have a history of heart rhythm problems, lung inflammation, lung problems, severe lung diseases, brain and spinal cord cancer spread, serious eye problems, or active tuberculosis.You have received certain cancer treatments, are currently receiving other cancer treatments (except for specific bone treatments), or have had major surgery or significant injury recently. You have also received a live, weakened vaccine in the past month.I do not have an ongoing infection needing IV treatment.I've had 1-2 chemotherapy treatments for my inoperable/metastatic cancer and it's still progressing.I had spinal cord compression or inactive brain tumors treated, don't need steroids or seizure meds, and it's been 2 weeks since my last radiation therapy.I had spinal cord compression or inactive brain tumors treated, don't need steroids or seizure meds, and it's been 2 weeks since my last radiation therapy.My breast cancer cannot be removed by surgery and is HR+ and HER2-.I am 18 years old or older.My condition matches the study's required disease characteristics.I am eligible for specific chemotherapy treatments as decided by my doctor.My physical ability hasn't worsened in the last 2 weeks and I can care for myself.I am 18 years old or older.I have long-term side effects from cancer treatment, but they are stable and not severe.I am eligible for chemotherapy with eribulin, capecitabine, vinorelbine, or gemcitabine.I am using birth control approved by this study's guidelines, not including oral estrogens.My HIV infection is not well controlled.
Research Study Groups:
This trial has the following groups:- Group 1: Dato-DXd
- Group 2: Investigators Choice of Chemotherapy (ICC)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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