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U3-1402 for Metastatic Breast Cancer
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective for patients with breast cancer that has spread.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I don't have any severe side effects from past treatments, except for hair loss.I do not have active brain or spinal cord complications needing steroids or seizure meds.I haven't taken chloroquine or hydroxychloroquine in the last 14 days.I haven't taken any cancer drugs or been in a cancer study in the last 3 weeks.You must have at least one measurable tumor according to specific guidelines, except if the cancer has only spread to the bones.I am using two forms of birth control, including a barrier method, and will continue for 7 months after the last dose.I have been treated with a HER3-targeting agent before.I agree not to father a child during the study and for 7 months after.I have a known eye condition from previous treatments.I haven't had major surgery in the last 4 weeks.I do not have severe illnesses like uncontrolled high blood pressure, diabetes, bleeding disorders, or active infections including hepatitis B, C, or HIV.I had brain metastases treatment over 4 weeks ago, no worsening, mild symptoms, and don't need steroids.My breast cancer is HER2-negative and I've received specific treatments.I am taking more than 10 mg of prednisone or similar medication daily.I do not have any major heart problems before starting the treatment.I have triple-negative breast cancer and received 1-5 chemotherapy treatments for it in the metastatic stage.My cancer is HER2-positive according to specific guidelines.I have HR+ HER2- breast cancer and was treated with endocrine therapy and a CDK 4/6 inhibitor.I haven't had extensive radiation therapy recently.My breast cancer has spread beyond the initial site.I have not had any other invasive cancers in the last 3 years.My organs are functioning well enough for treatment.I am 18 years old or older and have signed the consent form.I am willing to have biopsies before and during treatment, and my tumor can be biopsied.I have or might have a lung condition like ILD, pulmonary fibrosis, or radiation pneumonitis.I have severe lung problems not related to my cancer.I am fully active or restricted in physically strenuous activity but can do light work.
- Group 1: Part A
- Group 2: Part B
- Group 3: Part Z
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Has the FDA given its seal of approval to U3-1402?
"Considering the Phase 2 status of U3-1402, our team has assigned it a safety rating of 2 due to there being evidence for its safety but no record yet of efficacy."
Is this trial currently open to participants?
"Affirmative. According to data posted on clinicaltrials.gov, this medical study is actively recruiting as of now. After appearing online for the first time in May 2021, it was most recently updated in July 2022 and seeks 120 participants across 10 sites."
Are there multiple locations where this investigation is taking place in the state?
"The trial is currently accepting patients from a variety of sites, such as City of Hope in Duarte, Washington University School of Medicine in Saint Louis, and Florida Cancer Specialists-South in Fort Myers. Additionally, there are 7 other available venues."
What is the maximum number of participants allowed in this trial?
"This clinical trial necessitates 120 eligible patients to be involved in the study. Candidates can partake at either City of Hope situated in Duarte, California or Washington University School of Medicine located in Saint Louis, Missouri."
What are the major goals of this research trial?
"Daiichi Sankyo, Inc., the clinical trial sponsor company, aims to measure Proportion of participants without disease progression at 6 month (PFS-6) rate with single agent U3-1402 in MBC patients. Furthermore, they are aiming to track Clinical Benefit Rate (CBR), PFS among HER2+ MBC after trastuzumab deruxtecan treatment and median PFS for all participants over a 33 months period. To determine CBR according to RECIST v 1.1 criteria CR is defined as disappearance of all target and non-target lesions; PR is ≥30% decrease in sum"
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