trialsTrialActive

A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001)

A phase 2 trial of Tucatinib, Trastuzumab and Capecitabine in advanced solid tumours, run by Pfizer, active and no longer recruiting.

A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001) is a phase 2 interventional study registered as NCT04721977 by Pfizer, with 66 participants enrolled, started 2021-04-08 and due to reach its primary completion in 2023-07-17. Interventions recorded: Tucatinib, Trastuzumab and Capecitabine. Results have been posted on the registry.

Setting

A Phase 2 Open-label, Single Arm Study of MK-7119 in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic HER2+ Breast Carcinoma

Phase

Phase 2

Sponsor

Pfizer

Registry

Started

2021-04-08

Reported

2024

Enrolled

66 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

66 enrolled

Confirmed Objective Response Rate(cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Determined by Independent Central Review (ICR): Japanese Participantsprimaryresponse endpoint

35.4 out of 100 people had their tumour shrink with Tucatinib + Capecitabine + Trastuzumab.

There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
These results apply to the people the trial enrolled: A Phase 2 Open-label, Single Arm Study of MK-7119 in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic HER2+ Breast Carcinoma. People in a different situation may not see the same effect.
The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.
Only 66 people took part, so the numbers are less certain than in a large trial.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

66 enrolled.

Confirmed Objective Response Rate(cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Determined by Independent Central Review (ICR): Japanese Participantsprimary

Tucatinib + Capecitabine + Trastuzumab35.4 of 100

n = 48

Download

90% CI 24.0 to 48.3; Figures from the ClinicalTrials.gov results section (first posted 2024-08-09), not from a publication

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Confirmed Objective Response Rate(cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Determined by Independent Central Review (ICR): Japanese Participantsprimary	Tucatinib + Capecitabine + Trastuzumab	48	35.4%	-	-	link

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cancers

Metastatic cancer (cancer that has spread)

technologies

Cytotoxic chemotherapy HER2 tyrosine kinase inhibitors Monoclonal antibodies Small-molecule kinase inhibitors

drugs

ApprovedOral fluoropyrimidine prodrug (antimetabolite)

Capecitabine · Xeloda

ApprovedMonoclonal antibody (anti-HER2)

Trastuzumab · Herceptin (and biosimilars, Phesgo with pertuzumab)

ApprovedSmall-molecule kinase inhibitor (HER2)

Tucatinib · Tukysa

companies

Pfizer (incl. Seagen)