Trial · NCT04579380
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
NCT04579380, Phase 2, Active not recruiting, Seagen, a wholly owned subsidiary of Pfizer; results first posted 2024-11-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations. Trials, record NCT04579380. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04579380
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
- NCT number
- NCT04579380
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 217 participants, actual
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Conditions
- Uterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Urologic Neoplasms, Carcinoma, Non-Small-Cell Lung, HER2 Mutations Breast Neoplasms
- Interventions
- tucatinib, trastuzumab, fulvestrant
- First posted
- 2020-10-08
- Last updated
- 2026-08-21
- Results first posted
- 2024-11-13
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmed Objective Response Rate (cORR) as Assessed by Investigator | From the first dose of study treatment until the first documented CR or PR on or before the first documented PD or new anti-cancer therapies or death, whichever occurred first (up to 28.3 months) | Confirmed ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v)1.1 as assessed by investigator and was considered as confirmed when subsequent response was at least 4 weeks after initial response. As per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeter (mm). PR: at least a greater than or equal to (\>=)30 % decrease in the sum of diameters (SOD) of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. Disease progression (PD): at least \>=20% relative increase in SOD of target lesion taking as reference the smallest sum on study (including baseline sum if that is the smallest on study). |
| Secondary | Confirmed Disease Control Rate (DCR) as Assessed by Investigator | From the first dose study treatment until PD or death, whichever occurred first (approximately 52.7 months) | DCR was defined as the percentage of participants with confirmed CR, PR, or stable disease (SD or non-CR/non-PD) according to RECIST v1.1 as assessed by investigator. As per RECIST v1.1, CR: disappearance of all target (T) lesions and non-target (NT) lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least \>=30 % decrease in the SOD of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. PD: at least \>=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is the smallest on study). SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD while on study and cannot have met criteria for PD previously. |
| Secondary | Duration of Response (DOR) as Assessed by Investigator | From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (approximately 52.7 months) | DOR: time from first documentation of confirmed CR/PR to first documentation of PD according to RECIST v1.1 or death from any cause, whichever occurred earlier. Per RECIST v1.1, CR: disappearance of all T/NT lesions(L). Any pathological lymph nodes (whether T/NT) must have reduction in short axis to \<10 mm. PR: at least \>=30 % decrease in SOD of TL, taking reference baseline sum diameters. PD: at least \>=20% relative increase in SOD of TL taking reference smallest sum on study. Participants who do not have PD \& were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD/death occurred after two/more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation. |
| Secondary | Progression-Free Survival (PFS) as Assessed by Investigator | From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (approximately 52.7 months) | PFS was defined as time from the date of treatment initiation to date of PD as per RECIST v1.1 or death from any cause, whichever occurred first . As per RECIST v1.1, PD: least \>=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is smallest on study). Participants who do not have PD and were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD or death occurred after two or more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation. |
| Secondary | Overall Survival (OS) | From date of start of study treatment until date of death or censoring date (approximately 52.7 months) | OS was defined as the time from treatment initiation to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). Participants lacking data beyond the day of treatment initiation were censored on the date of treatment initiation (i.e., OS duration of 1 day). Kaplan-Meier method was used for evaluation. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 52.7 months) | An AE was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment. |
| Secondary | Number of Participants With Treatment Emergent Laboratory Test Abnormalities | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 52.7 months) | Treatment-emergent laboratory abnormalities were defined as abnormalities that are new or worsened on or after receiving the first dose of study treatment up to 30 days after the last dose of study treatment. The following laboratory abnormalities were assessed: A-) Hematology: hemoglobin decreased, leukocytes decreased, lymphocytes decreased and increased, neutrophils decreased and platelets decreased; B-) Chemistry: alanine aminotransferase increased, albumin decreased, alkaline phosphatase increased, aspartate aminotransferase increased, calcium corrected for albumin decreased and increased, creatinine increased, glomerular filtration rate estimated decreased, glucose decreased, lactate dehydrogenase increased, magnesium increased and decreased, potassium increased and decreased, sodium increased and decreased and total bilirubin increased. |
| Secondary | Number of Participants With Any Dose Modifications Due to AEs | From first dose of the study treatment (Day 1) up to the last dose of study treatment (approximately 52.7 months) | Dose modification included dose hold, dose reduction, or discontinuation of drugs. Dose reductions or treatment interruption/discontinuation were made at the discretion of the investigator. |
| Secondary | Number of Participants With TEAEs of Special Interest | From first dose of the study treatment (Day 1) up to the last dose of study treatment (approximately 52.7 months) | An adverse event of special interest (AESI) were any serious or nonserious AE that were of scientific or medical concern as defined by the sponsor and specific to the program, for which ongoing monitoring and rapid communication to the sponsor were appropriate. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib, trastuzumab or fulvestrant). AESIs for this study were related to hepatoxicity. |
| Secondary | Maximum Concentration (Cmax) of Tucatinib | Cycle 3 Day 1: anytime within 1-4 hours post-dose |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Confirmed Objective Response Rate (cORR) as Assessed by Investigator | From the first dose of study treatment until the first documented CR or PR on or before the first documented PD or new anti-cancer therapies or death, whichever occurred first (up to 28.3 months) | The Response-Evaluable analysis set includes all participants with measurable disease who meet the following 3 criteria: (1) had a baseline disease assessment, (2) received study treatment, and (3) had post-baseline disease assessment or discontinued treatment due to documented disease progression or clinical progression. | Percentage of participants | NUMBER |
| SECONDARY | Confirmed Disease Control Rate (DCR) as Assessed by Investigator | From the first dose study treatment until PD or death, whichever occurred first (approximately 52.7 months) | |||
| SECONDARY | Duration of Response (DOR) as Assessed by Investigator | From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (approximately 52.7 months) | |||
| SECONDARY | Progression-Free Survival (PFS) as Assessed by Investigator | From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (approximately 52.7 months) | |||
| SECONDARY | Overall Survival (OS) | From date of start of study treatment until date of death or censoring date (approximately 52.7 months) | |||
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 52.7 months) | |||
| SECONDARY | Number of Participants With Treatment Emergent Laboratory Test Abnormalities | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 52.7 months) | |||
| SECONDARY | Number of Participants With Any Dose Modifications Due to AEs | From first dose of the study treatment (Day 1) up to the last dose of study treatment (approximately 52.7 months) | |||
| SECONDARY | Number of Participants With TEAEs of Special Interest | From first dose of the study treatment (Day 1) up to the last dose of study treatment (approximately 52.7 months) | |||
| SECONDARY | Maximum Concentration (Cmax) of Tucatinib | Cycle 3 Day 1: anytime within 1-4 hours post-dose | The Pharmacokinetic (PK) analysis set included all participants in the safety set from whom at least one evaluable PK assessment was reported. | Nanogram per milliliter | GEOMETRIC_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Confirmed Objective Response Rate (cORR) as Assessed by Investigator | Tucatinib+Trastuzumab (Cohort 1) | 27.3 | 90% Confidence Interval 7.9 to 56.4 | Percentage of participants | |
| Confirmed Objective Response Rate (cORR) as Assessed by Investigator | Tucatinib+Trastuzumab (Cohort 2) | 13.3 | 90% Confidence Interval 4.7 to 28.0 | Percentage of participants | |
| Confirmed Objective Response Rate (cORR) as Assessed by Investigator | Tucatinib+Trastuzumab (Cohort 3) | 46.7 | 90% Confidence Interval 30.8 to 63.0 | Percentage of participants | |
| Confirmed Objective Response Rate (cORR) as Assessed by Investigator | Tucatinib+Trastuzumab (Cohort 4) | 8.0 | 90% Confidence Interval 1.4 to 23.1 | Percentage of participants | |
| Confirmed Objective Response Rate (cORR) as Assessed by Investigator | Tucatinib+Trastuzumab (Cohort 5) | 8.3 | 90% Confidence Interval 0.4 to 33.9 | Percentage of participants | |
| Confirmed Objective Response Rate (cORR) as Assessed by Investigator | Tucatinib+Trastuzumab (Cohort 6) | 22.6 | 90% Confidence Interval 11.1 to 38.3 | Percentage of participants | |
| Confirmed Objective Response Rate (cORR) as Assessed by Investigator | Tucatinib+Trastuzumab (Cohort 7) | 0 | 90% Confidence Interval 0.0 to 20.6 | Percentage of participants | |
| Confirmed Objective Response Rate (cORR) as Assessed by Investigator | Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8) | 41.9 | 90% Confidence Interval 26.9 to 58.2 | Percentage of participants | |
| Confirmed Objective Response Rate (cORR) as Assessed by Investigator | Tucatinib+Trastuzumab (Cohort 9) | 10.3 | 90% Confidence Interval 2.9 to 24.6 | Percentage of participants | |
| Maximum Concentration (Cmax) of Tucatinib | Tucatinib+Trastuzumab (Cohort 1) | 488.2 | Geometric Coefficient of Variation 104.9 | Nanogram per milliliter |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tucatinib+Trastuzumab (Cohort 1) | 11 | |
| Overall Study | STARTED | Tucatinib+Trastuzumab (Cohort 2) | 31 | |
| Overall Study | STARTED | Tucatinib+Trastuzumab (Cohort 3) | 30 | |
| Overall Study | STARTED | Tucatinib+Trastuzumab (Cohort 4) | 25 | |
| Overall Study | STARTED | Tucatinib+Trastuzumab (Cohort 5) | 12 | |
| Overall Study | STARTED | Tucatinib+Trastuzumab (Cohort 6) | 31 | |
| Overall Study | STARTED | Tucatinib+Trastuzumab (Cohort 7) | 13 | |
| Overall Study | STARTED | Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8) | 31 | |
| Overall Study | STARTED | Tucatinib+Trastuzumab (Cohort 9) | 33 | |
| Overall Study | COMPLETED | Tucatinib+Trastuzumab (Cohort 1) | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events2,214
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 | Anaemia | Blood and lymphatic system disorders | Tucatinib+Trastuzumab (Cohort 1) | 3 | 11 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Tucatinib+Trastuzumab (Cohort 2) | 6 | 31 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Tucatinib+Trastuzumab (Cohort 3) | 4 | 30 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Tucatinib+Trastuzumab (Cohort 4) | 7 | 25 | 13 |
| other | Anaemia | Blood and lymphatic system disorders | Tucatinib+Trastuzumab (Cohort 5) | 0 | 12 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Tucatinib+Trastuzumab (Cohort 6) | 5 | 31 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Tucatinib+Trastuzumab (Cohort 7) | 2 | 13 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8) | 3 | 31 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Tucatinib+Trastuzumab (Cohort 9) | 5 | 33 | 5 |
| other | Neutropenia | Blood and lymphatic system disorders | Tucatinib+Trastuzumab (Cohort 1) | 1 | 11 | 3 |
1 to 10 of 2,214Source ClinicalTrials.gov
See all 2,214 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tucatinib+Trastuzumab (Cohort 1) | 9 | 11 |
| Total, all-cause mortality | Tucatinib+Trastuzumab (Cohort 2) | 22 | 31 |
| Total, all-cause mortality | Tucatinib+Trastuzumab (Cohort 3) | 22 | 30 |
| Total, all-cause mortality | Tucatinib+Trastuzumab (Cohort 4) | 17 | 25 |
| Total, all-cause mortality | Tucatinib+Trastuzumab (Cohort 5) | 6 | 12 |
| Total, all-cause mortality | Tucatinib+Trastuzumab (Cohort 6) | 21 | 31 |
| Total, all-cause mortality | Tucatinib+Trastuzumab (Cohort 7) | 10 | 13 |
| Total, all-cause mortality | Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8) | 11 | 31 |
| Total, all-cause mortality | Tucatinib+Trastuzumab (Cohort 9) | 25 | 33 |
| Total, other adverse events | Tucatinib+Trastuzumab (Cohort 1) | 10 | 11 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT04579380
GET https://conductscience.org/api/trials/v1/NCT04579380/results?page=2