MedTrace Logo

Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer

NCT07494448 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-23

No results posted yet for this study

Summary

The JAZMINE study is a multicenter, open-label, non-comparative, phase Ib/II clinical trial to evaluate safety and preliminary efficacy of zanidatamab in combination with tucatinib and chemotherapy (capecitabine or eribulin mesylate) in HER2-positive advanced breast cancer.

Conditions

Interventions

DRUG

Zanidatamab

Will be administered as an intravenous (IV) infusion on Day 1 of each 21-day treatment cycle (Q3W). The dose of zanidatamab will be weight-based: 1800 mg for participants weighing \<70 kg and 2400 mg for participants weighing ≥70 kg. During phase Ib, the dose of zanidatamab will remain constant.

DRUG

Tucatinib

Will be administered orally at a dose of 300 mg twice daily (BID) on a continuous basis throughout each 21-day treatment cycle. During phase Ib, the dose of tucatinib will remain constant.

DRUG

Capecitabine

Will be administered orally twice daily (PO BID) on Days 1-14 of each 21-day treatment cycle during phase Ib. Dose escalation will be performed with a starting dose of 750 mg/m² PO BID, with escalation to 1000 mg/m² PO BID based on tolerability. If the 750 mg/m² dose is not well tolerated, capecitabine will be de-escalated to 650 mg/m² PO BID.

DRUG

Eribulin Mesilate injection

Will be administered intravenously on Days 1 and 8 of each 21-day treatment cycle during phase Ib. Dose escalation will be performed with a starting dose of 1.1 mg/m², with escalation to 1.4 mg/m² based on tolerability. If the 1.1 mg/m² dose is not well tolerated, eribulin will be de-escalated to 0.7 mg/m².

Sponsors & Collaborators

  • MedSIR

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-12-31
Completion
2028-05-31

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07494448 on ClinicalTrials.gov