BridgeMD
New treatment option for Breast Cancer
Official title Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT05748834
What this study is testing
What is Tucatinib?
Tucatinib is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for breast cancer.
Also referred to as Tukysa.
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 clinical trial is evaluating tucatinib in combination with Doxil in participants with human epidermal growth factor 2 positive (HER2+) locally advanced or metastatic breast cancer. The main goals of this study are to: Learn how well the combination of tucatinib and Doxil works Learn more about the side effects of the combination of tucatinib and Doxil
- 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
- Written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any...
- At least 18 years-of-age at the time of signature of the informed consent form (ICF)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Have a confirmed diagnosis of locally advanced/metastatic HER2+ breast cancer (based on local laboratory testing per American Society of Clinical...
- Have had prior treatment with at least 1 line of anti-HER2 therapy for locally advanced/metastatic disease or relapsed within 6 months of completion...
You likely can't join if
- Treatment with any of the following:
- Any systemic anti-cancer chemotherapy or small molecule, biologic, or hormonal agent from a previous treatment regimen or clinical study within 21...
- Prior treatment with anthracycline in any setting
- Major surgery (excluding placement of vascular access) within 28 days of first dose of study drugs
- Palliative radiation therapy within 14 days of first dose of study drugs
- Based on screening brain MRI, patients must not have any of the following:
See the full eligibility criteria
Who can join
- Written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses
- At least 18 years-of-age at the time of signature of the informed consent form (ICF)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Have a confirmed diagnosis of locally advanced/metastatic HER2+ breast cancer (based on local laboratory testing per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines...
- Have had prior treatment with at least 1 line of anti-HER2 therapy for locally advanced/metastatic disease or relapsed within 6 months of completion of adjuvant anti-HER2 therapy. Prior treatment with tucatinib in the...
- Measurable disease as measured by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Females of child-bearing potential should be using adequate contraceptive measures from the time of screening until 6 months following the last dose of study drug(s), should not be breast feeding and must have a...
- Post-menopausal: defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation
- Women under 50 years-of-age will be considered postmenopausal if they have been amenorrheic for at least 12 months following the cessation of exogenous hormonal treatments, and have serum follicle-stimulating hormone...
- Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their...
- Adequate hematologic function
- Absolute neutrophil count (ANC) ≥1500/µL
- Platelet count ≥100,000/µL (no transfusions allowed to meet this requirement)
- Hemoglobin ≥9 g/dL (at least 2-week washout from any transfusion)
- Adequate hepatic function
- Total bilirubin ≤1.5 × upper limit of normal (ULN). Exception: participants with known history of Gilbert's Syndrome who have a direct bilirubin ≤1.5 × ULN in addition to a normal aspartate aminotransferase (AST) and...
- AST and ALT ≤2.5 × ULN (≤5 × ULN if liver metastases are present)
- Estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73 m2
- Left ventricular ejection fraction (LVEF) ≥50% based on screening echocardiogram (ECHO)/multigated acquisition (MUGA)
- Central nervous system (CNS) Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), patients must have one of the following:
- No evidence of brain metastases
- Untreated brain metastases not needing immediate local therapy. For patients with untreated CNS lesions \>2.0 cm on screening contrast brain MRI, discussion with and approval from the Medical Monitor is required prior...
- Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions.
- Previously treated brain metastases:
- Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment...
- Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI performed during screening for this study may be eligible to enroll if all of the following criteria are met:
- Time since whole brain radiotherapy (WBRT) is ≥14 days prior to first dose of treatment, time since stereotactic radiosurgery (SRS) is ≥7 days prior to first dose of treatment, or time since surgical resection is ≥28...
- Other sites of disease assessable by RECIST 1.1 are present
What rules you out
- Treatment with any of the following:
- Any systemic anti-cancer chemotherapy or small molecule, biologic, or hormonal agent from a previous treatment regimen or clinical study within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of...
- Prior treatment with anthracycline in any setting
- Major surgery (excluding placement of vascular access) within 28 days of first dose of study drugs
- Palliative radiation therapy within 14 days of first dose of study drugs
- Based on screening brain MRI, patients must not have any of the following:
- Any untreated brain lesions \>2.0 cm in size, unless discussed with the Medical Monitor and approval for enrollment is granted
- Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \>2 mg of dexamethasone (or equivalent). However, patients on a chronic stable dose of ≤2 mg total daily of...
- Any brain lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to patient (e.g., brain...
- Known or suspected leptomeningeal disease (LMD) as documented by the Investigator
- Have poorly controlled (\>1 week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases, notwithstanding CNS-directed therapy.
- Use of a strong cytochrome P450 (CYP)2C8-inhibitor or use of a strong CYP3A4 or use of a CYP2C8 inducer within 5 days prior to the first dose of study treatment
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment. Note: patients with chronic Grade 2 toxicities who are asymptomatic or...
- Women who are pregnant or nursing or plan to become pregnant while in the study and for at least 6 months after the last administration of study treatment
- Men who plan to father a child while in the study and for at least 6 months after the last administration of study treatment
- Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of tucatinib (e.g., ulcerative disease, uncontrolled nausea...
- Any of the following cardiac criteria:
- Mean resting QT interval with QT corrected for heart rate by Fridericia's formula [QTcF]) prolongation to \>480 msec for females and \>460 msec for males in three successive screening measures
- Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third-degree heart block
- Congestive heart failure (New York Heart Association ≥ Grade 2 within past 6 months)
- Patients with a left ventricular ejection fraction (LVEF) \<50% or the lower limit of normal of the institutional standard
- As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection, including...
- Known human immunodeficiency virus (HIV) infection or positivity on immunoassay. Testing for seropositive status during screening will be at the discretion of the Investigator for people without previously reported...
- Presence of other active invasive cancers other than the one treated in this study within 3 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix...
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Columbia, Maryland, United States
- Bensalem, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States
- Norfolk, Virginia, United States
- Salem, Virginia, United States
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 Columbia, Maryland, United States; Bensalem, Pennsylvania, United States; Nashville, Tennessee, United States; Dallas, Texas, United States; San Antonio, Texas, United States; Norfolk, Virginia, United States and 1 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.