Not Yet RecruitingPhase 1/2

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

24 participantsStarted 2026-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants must be capable of understanding the purpose of the Study and have signed a written informed consent form (ICF) prior to beginning specific protocol procedures.
✓. Female or male participants ≥ 18 years of age at the time of signing the ICF.
✓. ECOG PS of 0-1.
✓. Minimum life expectancy of ≥ 12 weeks at screening.
✓. Unresectable locally advanced or metastatic disease documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.
✓. Locally confirmed HER2-positive breast cancer (immunohistochemistry \[IHC\] score of 3+ or ICH score of 2+ with confirmation of HER2 amplification by in situ hybridization \[ISH\]) per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 criteria on the most recent analyzed biopsy.
✓. Evaluable disease by RECIST v.1.1.
✓. All participants need to have experienced disease progression after at least one line, but no more than 3 lines, of anti-HER2-therapy for advanced disease.

Exclusion criteria

✕. Participation in another clinical trial, interventional or observational, until the Study's safety visit.
✕. Have received treatment with any systemic anti-cancer therapy (including hormonal therapy), non-CNS radiation, or experimental agent within ≤ 3 weeks prior to the first dose of Study treatments.
✕. Prior treatment with capecitabine and eribulin.
✕. Known or suspected leptomeningeal disease (LMD) as documented by the investigator.
✕. Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term (including massive uncontrolled effusions \[pleural, pericardial, peritoneal\] or pulmonary lymphangitis).
✕. Receipt of a live vaccine within 4 weeks prior to enrollment.
✕. History of prior allogeneic bone marrow, stem cell, or solid organ transplantation.
✕. The washout periods for prior anticancer therapies before randomization are as follows:

What they're measuring

To determine the recommended phase II dose (RP2D) of zanidatamab in combination with tucatinib and capecitabine in participants with HER2-positive ABC (Cohort A).

Timeframe: 24 days

To determine the recommended phase II dose (RP2D) of zanidatamab in combination with tucatinib and eribulin in participants with HER2-positive ABC (Cohort B).

Timeframe: 24 days

Trial details

NCT IDNCT07494448

SponsorMedSIR

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

MEDSIR

+ 34 932 214 135 contact.trials@medsir.org

View on ClinicalTrials.gov More HER 2 Positive Advanced Breast Cancer trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants must be capable of understanding the purpose of the Study and have signed a written informed consent form (ICF) prior to beginning specific protocol procedures.
✓. Female or male participants ≥ 18 years of age at the time of signing the ICF.
✓. ECOG PS of 0-1.
✓. Minimum life expectancy of ≥ 12 weeks at screening.
✓. Unresectable locally advanced or metastatic disease documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.
✓. Locally confirmed HER2-positive breast cancer (immunohistochemistry \[IHC\] score of 3+ or ICH score of 2+ with confirmation of HER2 amplification by in situ hybridization \[ISH\]) per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 criteria on the most recent analyzed biopsy.
✓. Evaluable disease by RECIST v.1.1.
✓. All participants need to have experienced disease progression after at least one line, but no more than 3 lines, of anti-HER2-therapy for advanced disease.

Exclusion criteria

✕. Participation in another clinical trial, interventional or observational, until the Study's safety visit.
✕. Have received treatment with any systemic anti-cancer therapy (including hormonal therapy), non-CNS radiation, or experimental agent within ≤ 3 weeks prior to the first dose of Study treatments.
✕. Prior treatment with capecitabine and eribulin.
✕. Known or suspected leptomeningeal disease (LMD) as documented by the investigator.
✕. Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term (including massive uncontrolled effusions \[pleural, pericardial, peritoneal\] or pulmonary lymphangitis).
✕. Receipt of a live vaccine within 4 weeks prior to enrollment.
✕. History of prior allogeneic bone marrow, stem cell, or solid organ transplantation.
✕. The washout periods for prior anticancer therapies before randomization are as follows:

What they're measuring

To determine the recommended phase II dose (RP2D) of zanidatamab in combination with tucatinib and capecitabine in participants with HER2-positive ABC (Cohort A).

Timeframe: 24 days

To determine the recommended phase II dose (RP2D) of zanidatamab in combination with tucatinib and eribulin in participants with HER2-positive ABC (Cohort B).

Timeframe: 24 days