Metastatic Breast CancerPhase 2NCT03501979
Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD
A Phase 2 study testing Tucatinib, Trastuzumab and Capecitabine in people with Metastatic Breast Cancer and Leptomeningeal Disease, run by University of Alabama at Birmingham at 9 sites in United States.
Trial summary
A phase 2 non-randomized study to assess the safety and efficacy of the combination of tucatinib and trastuzumab with capecitabine for the treatment of leptomeningeal metastases in HER2-neu positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Leptomeningeal Disease
- What is being tested?
- Tucatinib, Trastuzumab and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 9 sitesUnited States
- Study dates
- 20 Feb 2019to 22 Jun 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, age ≥18 years at time of consent
- 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.)
- Evidence of leptomeningeal disease (LMD) as diagnosed by a) presence of malignant cells in CSF (+CSF cytology) and/or b) Magnetic Resonance Imaging (MRI) evidence of LMD, plus clinical signs and/or symptoms. NOTE: Measurable extra-CNS disease is not required. Note: Patients who have MRI evidence of focal LMD with negative cytology and no symptoms are not eligible for enrollment.
- Karnofsky Performance Status ≥ 50 or Eastern Cooperative Oncology Group (ECOG) ≤ 3
- Patient is able and willing to undergo study-required testing including:
- Contrast-enhanced MRI Note: If patient has implants in place that are MRI incompatible, these must be removed prior to enrollment.
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- Placement of an Ommaya reservoir (ventricular access device). Note: This is mandatory for the first 15 patients enrolled onto the protocol (first stage). In the second stage, this is strongly recommended per protocol. If a patient cannot or chooses not to undergo Ommaya placement in the second stage, the patient will be allowed to enroll.
- Evaluation by medical oncologist at baseline and at every cycle (required)
- Evaluation by neurologist/neuro-oncologist at baseline and at every cycle (strongly recommended); if this is not possible at a site, a medical oncologist may per perform the protocol specified evaluations at each visit.
- Patients who are on steroids due to CNS disease or LMD diagnosis should be on a stable dose for at least 5 days prior to registration.
- 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. Note: Radiation for the purpose of palliation in the setting of a painful bone or dural metastasis can be allowed at the discretion of the treating physicians.
- 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.
Who cannot join
- Medical, social, or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
- Patient is pregnant or is breastfeeding. Note: If female and of child-bearing potential (females who are not surgically sterile or who have had a period in the last 12 months), has negative pregnancy test within 21 days prior to treatment. If a sexually active male or a sexually active female of child- bearing potential, agrees to use dual (two concurrent) forms of medically accepted contraception from the time of consent until 6 months after the last dose.
- History of allergic reactions to compounds of similar chemical or biological composition to capecitabine (Group A only), trastuzumab or tucatinib, except for a history of Grade 1 or Grade 2 infusion related reaction to trastuzumab, that has been successfully managed.
- Known to be HIV positive, or a carrier for Hepatitis B and/or Hepatitis C (whether active disease or not)
- Known liver disease, autoimmune hepatitis, or sclerosing cholangitis
- Inability to swallow pills or any significant gastrointestinal diseases, which would preclude adequate absorption of oral medications
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- Use of a strong CYP2C8/CYP3A4 inducer or inhibitor within three elimination half-lives of the inducer or inhibitor prior to the start of study treatment.
- Known impaired cardiac function or clinically significant cardiac disease such as ventricular arrhythmia requiring therapy or congestive heart failure. Note: Patients with hypertension must have controlled disease defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg on antihypertensive medications.
- Myocardial infarction or unstable angina within 6 months prior to the first dose of study drug.
- Patient with known dihydropyrimidine dehydrogenase deficiency
- Previous treatment with tucatinib
- Previous treatment with capecitabine within 12 months prior to study registration
- Prior history of other cancer (except non melanoma skin, cervical intraepithelial neoplasia) with evidence of disease within the last 5 years.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Michigan-
Ann Arbor, Michigan, 48109
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Dana Farber/Harvard Cancer Center-
Boston, Massachusetts, 02215
University of Chicago
Chicago, Illinois, 60637-1470
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University-Melvin and Bren Simon cancer center
Indianapolis, Indiana, 46202
UCSF-Mission Bay
San Francisco, California, 94158
University of Washington Medical Center-Montlake
Seattle, Washington, 98109
MedStar Georgetown University-Lombardi CCC
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase II Non-randomized Study to Assess the Safety and Efficacy of the Combination of Tucatinib and Trastuzumab and Capecitabine for Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer
A phase 2 non-randomized study to assess the safety and efficacy of the combination of tucatinib and trastuzumab with capecitabine for the treatment of leptomeningeal metastases in HER2-neu positive breast cancer.
Read the detailed description
The purpose of this study is to evaluate a new treatment for patients with HER2+ metastatic breast cancer (MBC) with leptomeningeal disease (LMD). This is a rare and fast-growing form of cancer. Leptomeningeal disease refers to the seeding of tumor cells to the leptomeninges and dissemination in the cerebrospinal fluid.
Currently, there are is no standard of care treatment for LMD. However, we think the combination therapy will be safe and well-tolerated and may also improve survival. Blood and spinal fluid samples will be collected to evaluate the effects on the body and the cancer, which will help provide greater understanding to therapy response in patients.
The study has a two-stage design with the first stage including 15 subjects from up to ten institutions nationwide. If it advances to the second stage based on the number of successes, another 15 subjects will be enrolled.
- Conditions
- Metastatic Breast Cancer, Leptomeningeal Disease
- Being tested
- Tucatinib, Trastuzumab, Capecitabine
- Keywords
- HER2+, metastatic breast cancer, leptomeningeal disease, tucatinib, trastuzumab, capecitabine
- Medical subject headings
- Breast Neoplasms, Meningeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TucatinibDrug
Also called ONT-380
Tucatinib study drug is given in tablet form and taken daily.
TrastuzumabDrug
Trastuzumab is approved by the FDA and is available commercially. Trastuzumab must be prepared and is administered intravenously.
CapecitabineDrug
Capecitabine is approved by the FDA and is available commercially as an oral drug.
| Study group | Role | What they receive |
|---|---|---|
| Tucatinib + Trastuzumab + Capecitabine | Experimental | 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. Receives: Drug: Tucatinib; Drug: Trastuzumab; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Subject Survival After Starting Study Treatment
Number of participants alive. A Gehan-like trial design with an interim futility analysis will be used.
Measured: Through study completions, an average of 2 years
Secondary outcomes (8)
Number of Adverse Events
Adverse event reporting will be graded following the National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. Subjects who receive at least one dose of the drug combination will be evaluable for toxicity from the time of the first dose.
Measured: up to 28 months
Progression Free Survival
From the start of treatment to 12 months
Measured: up to 12 months
Duration of Response in the Central Nervous System (CNS)
Data from subjects who have received at least one cycle of therapy and disease re-evaluation for CNS tumors by imaging, cytopathology, and clinical evaluation will be accumulated until disease progression.
Measured: up to 28 months
Clinical Benefit Rate (CBR) in CNS
The overall survival from the combination therapy is compared to the historical control. Clinical benefit is observed with a ratio of successes and corresponding confidence interval.
Measured: Baseline up to 28 months
Duration of Response in Extra-CNS Disease
Data from subjects who have received at least one cycle of therapy and disease re-evaluation for extra-CNS tumors by imaging, cytopathology, and clinical evaluation will be accumulated until disease progression. Extra-CNS response will be classified per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: up to 28 months
Clinical Benefit Rate (CBR) in Extra-CNS Disease
The overall survival from the combination therapy is compared to the historical control. Clinical benefit is observed with a ratio of successes and corresponding confidence interval.
Measured: up to 28 months
Symptom Burden
The M.D. Anderson Symptom Inventory Brain Tumor (MDASI -BT) module questionnaire will collect data at each study time point and evaluate changes of symptom burden. The MDASI-BT scale measures the severity of symptoms experienced by patients with breast cancer that interfere with daily living. A greater number of symptoms equals a greater interference with daily living. Symptoms of severity are assessed on a 0-213 scale with 0 being "lower quality of life" and 213 "higher quality of life".
Measured: Baseline, end of study (up to 28 months)
Quality of Life Assessment
The Linear Analog Scale Assessment Quality of Life will be used to evaluate changes in the quality of life at restaging visits.
Scale ranges from 0 to 100. Higher scores indicate a better quality of life.
Measured: up to 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start20 Feb 2019
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
Why it stopped: Study accrual ended early due to the FDA approval of tucatinib in metastatic HER2+ breast cancer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will receive combination treatment with tucatinib + trastuzumab + capecitabine every 21 days, which is one cycle. Evaluation will be done every two cycles with an MRI of the brain and spine. Cycles 3 and beyond will be at the discretion of the physician. A scan will be done every four cycles.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Translational Breast Cancer Research Consortium, Johns Hopkins University, Seagen Inc., University of Michigan, Georgetown University, University of California, San Francisco, University of Chicago, Indiana University, University of Washington, University of Texas
- Responsible party
- Principal investigator, Erica Stringer-Reasor, University of Alabama at Birmingham
- Investigators
- Erica M Stringer-Reasor, MD, Principal investigator, University of Alabama at BirminghamRashmi K Murthy, MD, MBE, Study chair, M.D. Anderson Cancer CenterBarbara J O'Brien, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501979
- Sponsor's protocol ID
- UAB 1794
- Status last verified
- Aug 2025
- First submitted
- 8 Apr 2018
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murthy RK, O'Brien BJ, Berry DA, Singareeka-Raghavendra A, Monroe MG, Johnson J, White J, Schwartz-Gomez J, Topletz-Erickson A, Lobbous M, Riley K, Melisko M, Morikawa A, Ferguson SD, de Groot JF, Krop IE, Valero V, Rimawi MF, Wolff AC, Tripathy D, Lin NU, Stringer-Reasor EM. Tucatinib-trastuzumab-capecitabine for treatment of leptomeningeal metastasis in women with HER2+ breast cancer: TBCRC049 phase 2 study results. Nat Cancer. 2026 Mar;7(3):424-434. doi: 10.1038/s43018-026-01120-7. Epub 2026 Mar 18.
PubMed 41851506
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Non-randomized Study to Assess the Safety and Efficacy of the Combination of Tucatinib and Trastuzumab and Capecitabine for Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT03501979
- Acronym / sponsor ID
- UAB 1794
- Conditions
- Metastatic Breast Cancer, Leptomeningeal Disease
- Keywords
- HER2+, metastatic breast cancer, leptomeningeal disease, tucatinib, trastuzumab, capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study accrual ended early due to the FDA approval of tucatinib in metastatic HER2+ breast cancer
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Translational Breast Cancer Research Consortium, Johns Hopkins University, Seagen Inc., University of Michigan, Georgetown University, University of California, San Francisco, University of Chicago, Indiana University, University of Washington, University of Texas
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Posted 8 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 2 non-randomized study to assess the safety and efficacy of the combination of tucatinib and trastuzumab with capecitabine for the treatment of leptomeningeal metastases in HER2-neu positive breast cancer.
Detailed description
The purpose of this study is to evaluate a new treatment for patients with HER2+ metastatic breast cancer (MBC) with leptomeningeal disease (LMD). This is a rare and fast-growing form of cancer. Leptomeningeal disease refers to the seeding of tumor cells to the leptomeninges and dissemination in the cerebrospinal fluid.
Currently, there are is no standard of care treatment for LMD. However, we think the combination therapy will be safe and well-tolerated and may also improve survival. Blood and spinal fluid samples will be collected to evaluate the effects on the body and the cancer, which will help provide greater understanding to therapy response in patients.
The study has a two-stage design with the first stage including 15 subjects from up to ten institutions nationwide. If it advances to the second stage based on the number of successes, another 15 subjects will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will receive combination treatment with tucatinib + trastuzumab + capecitabine every 21 days, which is one cycle. Evaluation will be done every two cycles with an MRI of the brain and spine. Cycles 3 and beyond will be at the discretion of the physician. A scan will be done every four cycles.
| Arm | Type | Receives |
|---|---|---|
| Tucatinib + Trastuzumab + Capecitabine | Experimental | Drug: Tucatinib, Drug: Trastuzumab, Drug: CapecitabineTucatinib 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Men and women, age ≥18 years at time of consent
- 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.)
- Evidence of leptomeningeal disease (LMD) as diagnosed by a) presence of malignant cells in CSF (+CSF cytology) and/or b) Magnetic Resonance Imaging (MRI) evidence of LMD, plus clinical signs and/or symptoms. NOTE: Measurable extra-CNS disease is not required. Note: Patients who have MRI evidence of focal LMD with negative cytology and no symptoms are not eligible for enrollment.
- Karnofsky Performance Status ≥ 50 or Eastern Cooperative Oncology Group (ECOG) ≤ 3
- Patient is able and willing to undergo study-required testing including:
Key exclusion criteria (13 listed)
- Medical, social, or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
- Patient is pregnant or is breastfeeding. Note: If female and of child-bearing potential (females who are not surgically sterile or who have had a period in the last 12 months), has negative pregnancy test within 21 days prior to treatment. If a sexually active male or a sexually active female of child- bearing potential, agrees to use dual (two concurrent) forms of medically accepted contraception from the time of consent until 6 months after the last dose.
- History of allergic reactions to compounds of similar chemical or biological composition to capecitabine (Group A only), trastuzumab or tucatinib, except for a history of Grade 1 or Grade 2 infusion related reaction to trastuzumab, that has been successfully managed.
- Known to be HIV positive, or a carrier for Hepatitis B and/or Hepatitis C (whether active disease or not)
- Known liver disease, autoimmune hepatitis, or sclerosing cholangitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TucatinibAlso: ONT-380Tucatinib study drug is given in tablet form and taken daily. | Drug | Tucatinib + Trastuzumab + Capecitabine |
| TrastuzumabTrastuzumab is approved by the FDA and is available commercially. Trastuzumab must be prepared and is administered intravenously. | Drug | Tucatinib + Trastuzumab + Capecitabine |
| CapecitabineCapecitabine is approved by the FDA and is available commercially as an oral drug. | Drug | Tucatinib + Trastuzumab + Capecitabine |
Primary outcome
Length of Subject Survival After Starting Study Treatment
Time frame: Through study completions, an average of 2 years
Number of participants alive. A Gehan-like trial design with an interim futility analysis will be used.
8 secondary outcomes
Number of Adverse Events
Time frame: up to 28 months
Progression Free Survival
Time frame: up to 12 months
Duration of Response in the Central Nervous System (CNS)
Time frame: up to 28 months
Clinical Benefit Rate (CBR) in CNS
Time frame: Baseline up to 28 months
Duration of Response in Extra-CNS Disease
Time frame: up to 28 months
Clinical Benefit Rate (CBR) in Extra-CNS Disease
Time frame: up to 28 months
Symptom Burden
Time frame: Baseline, end of study (up to 28 months)
Quality of Life Assessment
Time frame: up to 28 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41851506Murthy RK, O'Brien BJ, Berry DA, Singareeka-Raghavendra A, Monroe MG, Johnson J, White J, Schwartz-Gomez J, Topletz-Erickson A, Lobbous M, Riley K, Melisko M, Morikawa A, Ferguson SD, de Groot JF, Krop IE, Valero V, Rimawi MF, Wolff AC, Tripathy D, Lin NU, Stringer-Reasor EM. Tucatinib-trastuzumab-capecitabine for treatment of leptomeningeal metastasis in women with HER2+ breast cancer: TBCRC049 phase 2 study results. Nat Cancer. 2026 Mar;7(3):424-434. doi: 10.1038/s43018-026-01120-7. Epub 2026 Mar 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica M Stringer-Reasor, MD principal investigator
University of Alabama at Birmingham
Rashmi K Murthy, MD, MBE study chair
M.D. Anderson Cancer Center
Barbara J O'Brien, MD study chair
M.D. Anderson Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tucatinib, Trastuzumab and Capecitabine in people with Metastatic Breast Cancer and Leptomeningeal Disease, run by University of Alabama at Birmingham at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Subject Survival After Starting Study Treatment (time frame: Through study completions, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03501979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.