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New treatment option for Metastatic Breast Cancer
Official title Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT04965766
What this study is testing
What is U3-1402?
U3-1402 is an investigational medicine, being studied as a potential treatment for metastatic breast cancer.
Also referred to as HER3-DXd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to evaluate the efficacy and safety of U3-1402 in participants with advanced breast cancer (ABC). Participants have to be hormone-receptor positive (HR+) and have to be resistant to endocrine therapy and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults with histologically-confirmed HER2 negative, unresectable locally advanced or metastatic breast cancer that is hormone receptor positive (HR+)...
- Participants with a documented radiologic unresectable or metastatic progression
- Participants may have received anthracyclines and taxanes as (neo) adjuvant treatment and must have received one line of chemotherapy for Advanced...
- Participants must have a tumor site easily accessible to biopsy (with exception of bone metastasis)
- Participants must have at least one radiologically measurable lesion (different from the biopsy site)
You likely can't join if
- Breast cancer amenable for resection or radiation therapy with curative intent
- Any history of interstitial lung disease (ILD), actual ILD, or a suspicion of an ILD
- Clinically severe pulmonary compromise (based on investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not...
- Any underlying pulmonary disorder
- Any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement
- OR prior pneumonectomy
See the full eligibility criteria
Who can join
- Adults with histologically-confirmed HER2 negative, unresectable locally advanced or metastatic breast cancer that is hormone receptor positive (HR+) at the time of the first breast cancer diagnosis
- Participants with a documented radiologic unresectable or metastatic progression
- Participants may have received anthracyclines and taxanes as (neo) adjuvant treatment and must have received one line of chemotherapy for Advanced breast cancer (ABC), but not more than one line. Participants must have...
- Participants must have a tumor site easily accessible to biopsy (with exception of bone metastasis)
- Participants must have at least one radiologically measurable lesion (different from the biopsy site)
- Participants must have an ECOG PS equals to 0 or 1
- Participants must have a life expectancy of 12 weeks or more
- Participants must have adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to Cycle 1, Day 1
- Female patients of reproductive/childbearing potential must have a negative pregnancy test at screening (serum test within 14 days or urine test within 72 hours of enrollment). A positive urine pregnancy test result...
- Hormonal or nonhormonal intrauterine device (IUD)
- Progestogen-only subdermal contraceptive implant
- Bilateral tubal occlusion
- Vasectomized partner
- Complete sexual abstinence defined as refraining from heterosexual intercourse during and upon completion of the study and for at least 7 months for females after the last dose of study drug. Periodic abstinence...
- A male participant capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate each trial intervention. The length of...
- Progestogen-only contraceptive implant
- Hormonal or nonhormonal IUD
- Bilateral tubal occlusion (includes tubal ligation)
- Combined (estrogen- and progestogen-containing) hormonal contraception (oral, intravaginal, transdermal, injectable)
- Progestogen-only hormonal contraception (oral, injectable)
- Progesterone-only hormonal contraception where inhibition of ovulation is not the primary mode of action
- Cervical cap, diaphragm, or sponge with spermicide Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception...
- Participant must understand, sign, and date the written ICF prior to any protocol-specific procedures performed. Participant should be able and willing to comply with study visits and procedure as per protocol
- Participant must be affiliated to a social security system or beneficiary of the same
What rules you out
- Breast cancer amenable for resection or radiation therapy with curative intent
- Any history of interstitial lung disease (ILD), actual ILD, or a suspicion of an ILD
- Clinically severe pulmonary compromise (based on investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:
- Any underlying pulmonary disorder
- Any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement
- OR prior pneumonectomy
- The use of chronic systemic corticosteroids at a dose superior to 10 mg daily of prednisone or equivalent or any form of immunosuppressive therapy prior to Cycle 1 Day 1. Participants who require use of bronchodilators...
- Evidence of any leptomeningeal disease
- Evidence of corneal disease
- Any evidence of severe or uncontrolled systemic diseases including active bleeding diatheses, active infection, psychiatric illness/social situations, geographical factors, substance abuse, or other factors which in the...
- Evidence of clinically active spinal cord compression or brain metastases defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms
- Exposure to prior systemic anticancer therapy (including investigational agents) within 4 weeks or 5 half-lives (whichever is shorter) before enrollment.
- Inadequate washout period prior to Cycle 1 Day 1, defined as:
- Whole brain radiation therapy \<14 days or stereotactic brain radiation therapy \<7 days.
- Immune checkpoint inhibitor therapy \<21 days
- Hormonal therapy \<21 days
- Major surgery (excluding placement of vascular access) \<28 days.
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation \<28 days or palliative radiation therapy \<14 days.
- Chloroquine or hydroxychloroquine ≤ 14 days
- Live virus vaccination \<28 days.
- Prior treatment with an anti-HER3 antibody and/or ADC containing an exatecan derivative that is a topoisomerase I inhibitor
- Participants with a grade equals or greater than 2 unresolved toxicities from previous anticancer therapy (other than alopecia)
- A history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of U3-1402, or to other monoclonal antibodies
- Any evidence of primary malignancy other than locally advanced or metastatic lung cancer within three years prior to Cycle 1 Day 1, except adequately resected non-melanoma skin cancer, curatively treated in-situ...
- Uncontrolled or significant cardiovascular disease prior to Cycle 1 Day :
- Corrected QT interval higher than 470 ms for females and 450 ms for males according to Fridericia's formula (QTcF) and assessed based on triplicate ECGs, approximately 1 minute apart
- Left ventricular ejection fraction (LVEF) less than 50% by either ECHO or cardiac MRI or multigated acquisition scan (MUGA)
- Resting systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg
- Myocardial infarction within six months
- Symptomatic congestive heart failure (NYHA Classes 2 to 4 within 28 days before treatment)
- Uncontrolled angina pectoris within six months.
- Cardiac arrhythmia requiring antiarrhythmic treatment
- Evidence of active or uncontrolled hepatitis B virus infection (HBV) Participants are eligible:
- If HBsAg positive with chronic HBV infection (lasting 6 months or longer) and meet conditions below:
- HBV DNA viral load \<2000 IU/mL
- Start or maintain antiviral treatment if clinically indicated as per the investigator.
- Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST/ALT \<3 × ULN, which are not attributable to HBV infection - Evidence of active or uncontrolled hepatitis...
- History of hepatitis C infection eligible if the HCV viral load is below the level of detection in the absence of antiviral therapy during the previous 4 weeks
- Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST/ALT \< 3 × ULN, which are not attributable to HCV infection - Evidence of active or uncontrolled human...
- CD4+ T-cell count ≥350 cells/mm3 at the time of screening 16
- Virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) at the time of screening and for at least 12 weeks before screening
- No AIDS-defining opportunistic infections or conditions within the past 12 months
- On stable ART regimen, without changes in drugs or dose modification, for at least 4 weeks before trial entry (Day 1) and agree to continue ART throughout the trial.
- Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's judgment, could affect the safety of the subject; alter the...
- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection. people with localized fungal infections of skin or nails are eligible.
- Female patient who is pregnant or breastfeeding or intends to become pregnant during the study.
- Patient with any psychological, familial, sociological or geographical condition potentially hindering compliance with the study protocol procedures and follow-up schedule.
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
- Participation in another clinical trial evaluating an experimental drug (except non-treatment research
The study team makes the final eligibility decision.
Where it's taking place
- Dijon, France
- Limoges, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nice, France
- Paris, France
- Saint-Herblain, France
- Toulouse, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dijon, France; Limoges, France; Lyon, France; Marseille, France; Montpellier, France; Nice, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.