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Anti-metabolites
Triple Drug Therapy for Breast Cancer with Leptomeningeal Disease
Phase 2
Waitlist Available
Led By Erica M Stringer-Reasor, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior treatment allowances are as follows: >14 days since last dose of any previous endocrine therapy, chemotherapy, trastuzumab or other antibody-based therapy. NOTE: If patients have been previously receiving trastuzumab on a weekly basis (at a dose of 2mg/kg), only a 7 day washout will be required. >14 days or five half-lives since previous treatment with any experimental agent, whichever is greater, Cumulative dose of doxorubicin >360 mg/m2 or previous treatment with another anthracycline with cumulative dose equivalent to >360 mg/m2 doxorubicin is not allowed. Patients must not have received any therapy specifically directed at LMD, including prior systemic or intrathecal therapy for LMD. Radiotherapy: Patients must not have received radiotherapy to the neuroaxis following diagnosis of LMD for the purpose of treating LMD, and may not receive radiotherapy to the neuroaxis concurrently with the study drug; Patients must not have received whole brain radiotherapy for parenchymal metastases within the last 2 weeks (14 days) or focal CNS radiotherapy within 1 week (7 days) prior to first dose of study drug. All toxicity related to prior cancer therapies must have resolved to ≤ Grade 1, with the following exceptions: alopecia; neuropathy, which must have resolved to ≤ Grade 2; and CHF, which must have been ≤ Grade 1 in severity at the time of occurrence, and must have resolved completely. Must be without significant systemic illness (e.g. infection unresponsive to treatment after 7 days) Adequate hematologic, liver, and renal function, as follows: Hemoglobin ≥ 9 g/dL, ANC ≥ 1000 cells/μL, Platelets ≥ 100,000/μ, Total bilirubin ≤ 1.5 X upper limit of normal (ULN), unless a known history of Gilbert's disease (≤ 3 X ULN), Transaminases (AST/SGOT and ALT/SGPT) ≤ 2.5X ULN (< 5 X ULN if liver metastases are present), International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 X ULN, Creatinine clearance (CrCL) ≥ 50 mL/min, Left ventricular ejection fraction (LVEF) must be within institutional limits of normal as assessed by ECHO or MUGA documented within 4 weeks prior to enrollment on the study, Able to understand the study requirements and document informed consent indicating his/her awareness of the investigational nature and the risks of this study.
Histologically proven metastatic infiltrating carcinoma of the breast that is HER2 positive - Immunohistochemistry (IHC) 3+ and/or Fluorescence in situ hybridization (FISH) ratio >2.0, or average HER2 copy number >6.0 signals per cell or per current ASCO-CAP (American Society of Clinical Oncology - College of American Pathologists) or NCCN (National Comprehensive Cancer Network) guidelines. (NOTE: HER2 testing may be performed on primary and/or metastatic site; Any estrogen and progesterone [ER/PR] status is allowed.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat HER2-neu positive breast cancer that has spread to the leptomeninges (the thin layers of tissue that surround the brain and spinal cord).
Who is the study for?
Adults with HER2-positive breast cancer that has spread to the lining of the brain and spinal cord (LMD) can join. They must have finished certain previous treatments, not had specific therapies for LMD, and be stable on steroids if used. Participants need good heart, liver, kidney function, no severe illnesses or recent heart attacks, and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing a combination of three drugs: Tucatinib, Trastuzumab, and Capecitabine in patients with HER2+ breast cancer affecting the brain/spinal cord lining. It's a phase 2 study focusing on safety and how well these drugs work together without randomizing participants.See study design
What are the potential side effects?
Possible side effects include diarrhea from Capecitabine; heart issues from Trastuzumab; liver problems or fatigue from Tucatinib. Side effects vary by individual but are monitored closely throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is HER2 positive based on specific tests.
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I can take care of myself but may not be able to do any work.
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I have been diagnosed with cancer in the lining of my brain or spinal cord.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Length of Subject Survival After Starting Study Treatment
Secondary outcome measures
Clinical Benefit Rate (CBR) in CNS
Clinical Benefit Rate (CBR) in Extra-CNS Disease
Number of Adverse Events
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Tucatinib + Trastuzumab + CapecitabineExperimental Treatment3 Interventions
Tucatinib will be taken orally at 300 mg twice a day starting with Cycle 1, Day 1. A cycle consists of 21 days. Capecitabine will be taken orally at 1000 mg/m2 twice a day on Days 1-14 starting with cycle 1. Trastuzumab is given intravenously as a loading dose of 8 mg/kg on Cycle 1, Day 1 and then at 6 mg/kg for all subsequent cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tucatinib
FDA approved
Trastuzumab
FDA approved
Capecitabine
FDA approved
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,280,027 Total Patients Enrolled
32 Trials studying Breast Cancer
4,491 Patients Enrolled for Breast Cancer
Translational Breast Cancer Research ConsortiumOTHER
22 Previous Clinical Trials
2,340 Total Patients Enrolled
13 Trials studying Breast Cancer
1,575 Patients Enrolled for Breast Cancer
Johns Hopkins UniversityOTHER
2,258 Previous Clinical Trials
14,820,516 Total Patients Enrolled
28 Trials studying Breast Cancer
23,508 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong drugs that affect liver enzymes recently.I have heart problems or high blood pressure that is not well-controlled.My breast cancer is HER2 positive based on specific tests.I have a liver condition or autoimmune hepatitis.I have not had a heart attack or unstable chest pain in the last 6 months.I am willing to undergo all required tests and treatments for the study, including MRI and Ommaya reservoir placement.I am not pregnant or breastfeeding and agree to use two forms of contraception.I have no severe allergies to capecitabine, trastuzumab, or tucatinib, except for manageable reactions to trastuzumab.I have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.I have been treated with capecitabine in the last 12 months.I have had cancer other than non-melanoma skin or cervical pre-cancer in the last 5 years.I can take care of myself but may not be able to do any work.I have been diagnosed with cancer in the lining of my brain or spinal cord.I am HIV positive or have Hepatitis B/C.I cannot swallow pills or have a gut condition affecting medication absorption.I have been treated with tucatinib before.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Tucatinib + Trastuzumab + Capecitabine
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
What are some possible negative outcomes of Trastuzumab?
"Trastuzumab is still being clinically tested for efficacy, so it only received a score of 2 in terms of safety."
Answered by AI
What other scientific research has included Trastuzumab?
"Trastuzumab's first clinical trial was in 1999 at Ospedale di Circolo e Fondazione Macchi. 882 trials have completed since then, with 539 active studies as of now. There is a significant amount of on-going research taking place in Birmingham, Alabama."
Answered by AI
How many people have volunteered to participate in this experiment?
"As of right now, this trial is not looking for any more patients. However, it's worth noting that the first posting was on February 20th, 2019 and the most recent update occurred on October 12th, 2021. Additionally, there are 2388 other studies involving malignant neoplasms currently enrolling participants as well as 539 trials for Trastuzumab."
Answered by AI
Are recruitment efforts for this experiment still ongoing?
"Unfortunately, this particular study is not currently recruiting patients. Although, it is important to note that there are other trials (2388 studies for malignant neoplasms and 539 for Trastuzumab) that are presently looking for participants."
Answered by AI
To what extent is Trastuzumab used in medical treatments?
"Trastuzumab offers a potential treatment option for patients with refractory fallopian tube carcinoma, high risk of recurrence, and metastatic colorectal carcinoma."
Answered by AI
How many different research facilities are participating in this clinical trial?
"The 9 locations running this study are as follows: University of Alabama at Birmingham in Birmingham, MedStar Georgetown University-Lombardi CCC in Washington, and UCSF-Mission Bay in San Francisco. There are also 6 other sites."
Answered by AI
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