Trial · NCT05356897
Tucatinib Combined with Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study
NCT05356897, Phase 2, Withdrawn, Academic and Community Cancer Research United
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Tucatinib Combined with Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study. Trials, record NCT05356897. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05356897
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tucatinib Combined with Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study
- NCT number
- NCT05356897
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Academic and Community Cancer Research United
- Conditions
Metastatic Colon Adenocarcinoma, Metastatic Colorectal Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Stage IV Colon Cancer AJCC V8, Stage IV Colorectal Cancer AJCC V8, Stage IV Rectal Cancer AJCC V8
- Interventions
- Trastuzumab, Trifluridine and Tipiracil Hydrochloride, Tucatinib
- First posted
- 2022-05-02
- Last updated
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival rate | At 2 months | Defined as progression-free and alive at the 2 months disease evaluation scan. Disease status will be assessed using Response Evaluation Critera in Solid Tumors (RECIST) version (v). 1.1. Evaluable patients are defined as those who are eligible, consented, and received any protocol treatment. A 95% confidence interval will be calculated using the method proposed by Koyama and Chen, 2008 and implemented with the R software package clinfun (RStudio, 2021; Venkatraman, 2018). |
| Secondary | Clinical benefit | Up to 4 years | Defined as achieving complete response (CR), partial response (PR), or stable disease (SD) for at least 4 months while on treatment. Disease status will be assessed using RECIST v. 1.1 criteria. Clinical Benefit Rate will be calculated as the proportion of evaluable patients who achieve clinical benefit. The final CBR point estimate and corresponding 95% confidence interval calculated using the binomial exact method (Clopper \& Pearson, 1934). |
| Secondary | Overall response | Up to 4 years | Defined as achieving CR or PR while on treatment. Disease status will be assessed using RECIST v. 1.1 criteria. Overall Response Rate will be calculated as the proportion of evaluable patients who achieve response. The final ORR point estimate and corresponding 95% confidence interval calculated using the binomial exact method. |
| Secondary | Overall survival (OS) | From registration to death from any cause, assessed up to 4 years | Will be estimated using the Kaplan-Meier method. Patients who are alive will be censored at the last follow-up date. The report will include the median OS and corresponding 95% confidence interval, which will be calculated using the method proposed by Brookmeyer and Crowley, 1982. |
| Secondary | Incidence of adverse events | Up to 4 years | All patients who have initiated treatment will be considered evaluable for adverse event analyses. The rate of patients experiencing a grade 3+ adverse event will be reported. Further analyses of adverse event rates will be considered exploratory. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05356897
GET https://conductscience.org/api/trials/v1/NCT05356897/registered