Trial · NCT03501979
Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD
NCT03501979, Phase 2, Terminated, University of Alabama at Birmingham; results first posted 2023-02-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD. Trials, record NCT03501979. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03501979
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD
- NCT number
- NCT03501979
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Metastatic Breast Cancer, Leptomeningeal Disease
- Interventions
- Tucatinib, Trastuzumab, Capecitabine
- First posted
- 2018-04-18
- Last updated
- 2025-08-29
- Results first posted
- 2023-02-08
- Limitations and caveats
- The study only remains open to monitor patients for overall survival per the primary endpoint after FDA approval was granted for tucatinib in advanced stage HER2+ breast cancer in April 2020.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Length of Subject Survival After Starting Study Treatment | 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. |
| Secondary | Number of Adverse Events | up to 28 months | 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. |
| Secondary | Progression Free Survival | up to 12 months | From the start of treatment to 12 months |
| Secondary | Duration of Response in the Central Nervous System (CNS) | up to 28 months | 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. |
| Secondary | Clinical Benefit Rate (CBR) in CNS | Baseline up to 28 months | 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. |
| Secondary | Duration of Response in Extra-CNS Disease | up to 28 months | 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. |
| Secondary | Clinical Benefit Rate (CBR) in Extra-CNS Disease | up to 28 months | 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. |
| Secondary | Symptom Burden | Baseline, end of study (up to 28 months) | 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". |
| Secondary | Quality of Life Assessment | up to 28 months | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Length of Subject Survival After Starting Study Treatment | Through study completions, an average of 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Adverse Events | up to 28 months | participants | NUMBER | |
| SECONDARY | Progression Free Survival | up to 12 months | months | MEDIAN | |
| SECONDARY | Duration of Response in the Central Nervous System (CNS) | up to 28 months | months | MEDIAN | |
| SECONDARY | Clinical Benefit Rate (CBR) in CNS | Baseline up to 28 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Response in Extra-CNS Disease | up to 28 months | months | MEDIAN | |
| SECONDARY | Clinical Benefit Rate (CBR) in Extra-CNS Disease | up to 28 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Symptom Burden | Baseline, end of study (up to 28 months) | score on a scale | MEAN | |
| SECONDARY | Quality of Life Assessment | up to 28 months | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Length of Subject Survival After Starting Study Treatment | Tucatinib + Trastuzumab + Capecitabine | 6 | Participants | ||
| Number of Adverse Events | Tucatinib + Trastuzumab + Capecitabine | diarrhea | 13 | participants | |
| Number of Adverse Events | Tucatinib + Trastuzumab + Capecitabine | fatigue | 9 | participants | |
| Number of Adverse Events | Tucatinib + Trastuzumab + Capecitabine | nausea/vomiting | 8 | participants | |
| Number of Adverse Events | Tucatinib + Trastuzumab + Capecitabine | hand-foot syndrome | 13 | participants | |
| Number of Adverse Events | Tucatinib + Trastuzumab + Capecitabine | liver function test elevation | 11 | participants | |
| Progression Free Survival | Tucatinib + Trastuzumab + Capecitabine | 10 | 95% Confidence Interval 4.1 to 10 | months | |
| Duration of Response in the Central Nervous System (CNS) | Tucatinib + Trastuzumab + Capecitabine | 6.9 | 95% Confidence Interval 2.8 to 13.8 | months | |
| Clinical Benefit Rate (CBR) in CNS | Tucatinib + Trastuzumab + Capecitabine | 6 | Participants | ||
| Duration of Response in Extra-CNS Disease | Tucatinib + Trastuzumab + Capecitabine | 4.1 | 95% Confidence Interval 2.3 to 11.4 | months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tucatinib + Trastuzumab + Capecitabine | 17 | |
| Overall Study | COMPLETED | Tucatinib + Trastuzumab + Capecitabine | 17 | |
| Overall Study | NOT COMPLETED | Tucatinib + Trastuzumab + Capecitabine | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Tucatinib + Trastuzumab + Capecitabine | 13 | 17 | 13 |
| other | Fatigue | General disorders | Tucatinib + Trastuzumab + Capecitabine | 10 | 17 | 10 |
| other | Nausea/Vomiting | Gastrointestinal disorders | Tucatinib + Trastuzumab + Capecitabine | 10 | 17 | 10 |
| other | Hand Foot Syndrome | Skin and subcutaneous tissue disorders | Tucatinib + Trastuzumab + Capecitabine | 13 | 17 | 13 |
| other | Elevated liver function test | Gastrointestinal disorders | Tucatinib + Trastuzumab + Capecitabine | 11 | 17 | 11 |
| serious | Elevated liver function test | Gastrointestinal disorders | Tucatinib + Trastuzumab + Capecitabine | 1 | 17 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tucatinib + Trastuzumab + Capecitabine | 11 | 17 |
| Total, other adverse events | Tucatinib + Trastuzumab + Capecitabine | 13 | 17 |
| Total, serious adverse events | Tucatinib + Trastuzumab + Capecitabine | 1 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41851506 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03501979
GET https://conductscience.org/api/trials/v1/NCT03501979/registered