Trial · NCT07494448
Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer
NCT07494448, Phase 1, Phase 2, Not yet recruiting, MedSIR
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer. Trials, record NCT07494448. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07494448
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer
- NCT number
- NCT07494448
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 24 participants, estimated
- Lead sponsor
- MedSIR
- Conditions
- HER 2 Positive Advanced Breast Cancer, Breast Cancer
- Interventions
- Zanidatamab, Tucatinib, Capecitabine, Eribulin Mesilate injection
- First posted
- 2026-03-27
- Last updated
- 2026-04-23
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To determine the recommended phase II dose (RP2D) of zanidatamab in combination with tucatinib and capecitabine in participants with HER2-positive ABC (Cohort A). | 24 days | The maximum tolerated dose (MTD) of zanidatamab administered in combination with tucatinib and capecitabine, as determined by the proportion of DLTs observed. The RP2D will be established based on the MTD, the overall safety and tolerability profile and early efficacy data (Cohort A). Note: To identify the recommended dose, other available data from secondary endpoints may be taken into consideration. |
| Primary | To determine the recommended phase II dose (RP2D) of zanidatamab in combination with tucatinib and eribulin in participants with HER2-positive ABC (Cohort B). | 24 days | The MTD of zanidatamab administered in combination with tucatinib and eribulin, as determined by the proportion of DLTs observed. The RP2D will be established based on the MTD, the overall safety and tolerability profile and early efficacy data (Cohort B). |
| Secondary | To assess the preliminary efficacy of capecitabine-based therapy (Cohort A) and eribulin-based therapy (Cohort B) in combination with zanidatamab and tucatinib in terms of Investigator-assessed ORR in participants with HER2-positive ABC. | Until EoS (9 months after last participant in phase II starts treatment unless premature termination of the Study). | ORR, defined as the number of participants with CR or PR, divided by the number of participants in the analysis population, as assessed by the Investigator per RECIST v.1.1 (Cohort A and Cohort B) |
| Secondary | To assess the preliminary efficacy of capecitabine-based therapy (Cohort A) and eribulin-based therapy (Cohort B) in combination with zanidatamab and tucatinib in terms of Investigator-assessed IC-ORR in participants with HER2-positive ABC. | Until EoS (9 months after last participant in phase II starts treatment unless premature termination of the Study). | IC-ORR, defined as the percentage of participants with IC CR or PR, divided by the number of participants in the analysis population, assessed by the Investigator per RANO-BM criteria (Cohort A and Cohort B; only in participants with BM). |
| Secondary | To assess the preliminary efficacy of capecitabine-based therapy (Cohort A) and eribulin-based therapy (Cohort B) in combination with zanidatamab and tucatinib in terms of Investigator-assessed PFS in participants with HER2-positive ABC. | Until EoS (9 months after last participant in phase II starts treatment unless premature termination of the Study). | PFS, defined as the period from Study treatment initiation to the first occurrence of documented radiographic disease progression or death from any cause, whichever occurs first, as assessed by the investigator using RECIST v.1.1. criteria (Cohort A and Cohort B). |
| Secondary | To assess the preliminary efficacy of capecitabine-based therapy (Cohort A) and eribulin-based therapy (Cohort B) in combination with zanidatamab and tucatinib in terms of Investigator-assessed IC-PFS in participants with HER2-positive ABC | Until EoS (9 months after last participant in phase II starts treatment unless premature termination of the Study). | IC-PFS, defined as the period from treatment initiation to the first occurrence of documented radiographic intracranial progression or death from any cause, whichever occurs first, as assessed by the Investigator per RANO-BM criteria. (Cohort A and Cohort B; only in participants with BM) |
| Secondary | To determine the safety and toxicity profile according to the NCI-CTCAE v.5.0 of capecitabine-based therapy in combination with zanidatamab and tucatinib in participants with HER2-positive ABC (Cohort A). | Until EoS (9 months after last participant in phase II starts treatment unless premature termination of the Study). | Safety and tolerability as per NCI-CTCAE v.5.0 (Cohort A). |
| Secondary | To determine the safety and toxicity profile according to the NCI-CTCAE v.5.0 of eribulin-based therapy in combination with zanidatamab and tucatinib in participants with HER2-positive ABC (Cohort B). | Until EoS (9 months after last participant in phase II starts treatment unless premature termination of the Study). | Safety and tolerability as per NCI-CTCAE v.5.0 (Cohort B). |
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.
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.
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/NCT07494448
GET https://conductscience.org/api/trials/v1/NCT07494448/registered