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Anti-tumor antibiotic
Tucatinib + Doxil for Breast Cancer
Phase 2
Recruiting
Research Sponsored by SCRI Development Innovations, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 immunohistochemistry 3+ (IHC3+) or fluorescence in situ hybridization + (FISH+))
At least 18 years-of-age at the time of signature of the informed consent form (ICF)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 40 months.
Awards & highlights
Study Summary
This trial tests a new combo to treat HER2+ breast cancer. It looks at how well it works and any side effects.
Who is the study for?
This trial is for adults with HER2+ advanced or metastatic breast cancer who've had at least one anti-HER2 therapy. They must be in good health, not planning to have children, and able to use two forms of contraception. Excluded are those with other active cancers, recent major surgery, certain infections like HIV or hepatitis B/C, uncontrolled diseases such as hypertension or diabetes, and specific heart conditions.Check my eligibility
What is being tested?
The study tests the effectiveness and side effects of combining tucatinib with Doxil in treating HER2+ breast cancer that has spread. Participants will receive both medications and researchers will monitor how well this combination works compared to previous treatments they've received.See study design
What are the potential side effects?
Potential side effects include typical chemotherapy-related issues like nausea, fatigue, hair loss (alopecia), low blood counts leading to increased infection risk; heart problems due to Doxil; plus diarrhea and liver issues from tucatinib. Side effects vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is advanced or has spread and is HER2 positive.
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I am 18 years old or older.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 40 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 40 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) to assess the anti-tumor activity of tucatinib in combination with Doxil using RECIST v1.1.
Secondary outcome measures
Number of participants with treatment-related adverse events as assessed by common terminology criteria for adverse events (CTCAE) v5.0.
Progression-free survival (PFS) to assess the anti-tumor activity of tucatinib in combination with Doxil using RECIST v1.1.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Tucatinib Experimental Treatment ArmExperimental Treatment2 Interventions
Participants will receive tucatinib 300mg by mouth twice daily continuously in combination with Doxil 40mg/m2 given intravenously on day 1 of each cycle. Cycles will be 28 days. Up to 36 participants will be enrolled in this Phase 2 study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tucatinib
2017
Completed Phase 2
~520
Doxil
2008
Completed Phase 2
~990
Find a Location
Who is running the clinical trial?
SCRI Development Innovations, LLCLead Sponsor
191 Previous Clinical Trials
13,527 Total Patients Enrolled
25 Trials studying Breast Cancer
2,428 Patients Enrolled for Breast Cancer
Seagen Inc.Industry Sponsor
208 Previous Clinical Trials
74,192 Total Patients Enrolled
5 Trials studying Breast Cancer
3,272 Patients Enrolled for Breast Cancer
Erika Hamilton, MDStudy ChairSCRI Development Innovations, LLC
4 Previous Clinical Trials
812 Total Patients Enrolled
1 Trials studying Breast Cancer
390 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have large brain tumors, uncontrolled seizures, or certain brain diseases.I do not have stomach or bowel problems that affect how my body handles medicine.My blood counts are within a healthy range.Your heart is pumping blood effectively, as shown in a recent heart test.My brain MRI meets the specific criteria for brain metastases.I don't have any lasting side effects from previous treatments, except for hair loss.My breast cancer is advanced or has spread and is HER2 positive.I am not pregnant, not breastfeeding, and I'm using birth control or cannot have children.I am using two forms of birth control, including a barrier method, as required.You have a measurable tumor according to specific guidelines.I have not had any other invasive cancers in the last 3 years, except for certain skin cancers, cervical cancers, or tumors treated locally.I haven't taken any cancer drugs from a past treatment or study recently.I have not had major surgery in the last 4 weeks.My heart health meets the study's requirements.I am HIV positive.I am 18 years old or older.I plan to father a child during the study and for 6 months after it ends.I do not have severe illnesses like uncontrolled high blood pressure, diabetes, bleeding disorders, or active infections.I am fully active or restricted in physically strenuous activity but can do light work.Your kidney function, measured by eGFR, is above 50 mL/min/1.73 m2.I've had anti-HER2 treatment for advanced cancer or it came back within 6 months after finishing therapy.My liver is working well.I haven't taken strong CYP2C8 or CYP3A4 inhibitors, or CYP2C8 inducers in the last 5 days.I have been treated with anthracycline before.I have received palliative radiation therapy within the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Tucatinib Experimental Treatment Arm
Awards:
This trial has 1 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the United States Food and Drug Administration granted approval for Tucatinib Experimental Treatment Arm?
"Considering the Phase 2 status of Tucatinib Experimental Treatment Arm, our team at Power assesses its safety level to be a 2 as there is some evidence supporting this drug's security but none proving its efficacy."
Answered by AI
Is the enrollment for this medical research still open?
"According to the clinicaltrials.gov database, this medical study is actively seeking participants. This trial was initially posted on June 1st 2023 with its most recent update occurring at that same time."
Answered by AI
How many participants are contributing to the research of this trial?
"Affirmative. Clinicaltrials.gov indicates that the recruitment phase of this trial has begun, which was announced on June 1st 2023 and updated since then. The study is looking to enrol 36 patients from a single location."
Answered by AI
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