200 Participants Needed

Zanidatamab for Breast Cancer

Recruiting at 18 trial locations
CT
Overseen ByClinical Trial Disclosure & Transparency
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Jazz Pharmaceuticals
Must be taking: Trastuzumab deruxtecan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have been treated with systemic cancer therapies, including hormonal therapies for breast cancer, within 4 weeks or 5 half-lives before joining the trial.

What data supports the effectiveness of the drug Zanidatamab for breast cancer?

The research highlights the effectiveness of similar drugs like trastuzumab deruxtecan and trastuzumab emtansine, which target the HER2 protein in breast cancer, showing improved survival and outcomes. These findings suggest that targeting HER2, as Zanidatamab does, could be beneficial for breast cancer treatment.12345

What makes the drug Zanidatamab unique for breast cancer treatment?

Zanidatamab is unique because it targets two different parts of the HER2 protein on cancer cells, which may help overcome resistance to other HER2-targeted therapies. This dual-targeting approach is different from other treatments that typically focus on a single target.678910

Eligibility Criteria

This trial is for people with certain types of cancer (like breast, stomach, lung, and others) that have a lot of HER2 protein on their cells. Participants should have tried other treatments before without success.

Inclusion Criteria

My organs are working well.
I am of childbearing age and my pregnancy test is negative.
I am willing to use two forms of birth control if I or my partner can have children.
See 8 more

Exclusion Criteria

I do not have any serious health or mental conditions that would stop me from receiving the study treatment.
My colorectal cancer has KRAS/NRAS or BRAF mutations.
I have had major surgery or experienced significant injury in the past.
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zanidatamab treatment for HER2-expressing solid tumors

Up to 2.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

  • Zanidatamab
Trial OverviewThe study is testing the effectiveness and safety of a drug called Zanidatamab in patients whose tumors overexpress the HER2 protein and who have already undergone previous treatments.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Zanidatamab treatment armExperimental Treatment1 Intervention
Eligible participants receiving zanidatamab treatment

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jazz Pharmaceuticals

Lead Sponsor

Trials
252
Recruited
35,100+
Bruce C. Cozadd profile image

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin profile image

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Jazz Pharmaceuticals Ireland Limited

Industry Sponsor

Trials
2
Recruited
250+

Findings from Research

The Phase III DESTINY-Breast04 trial demonstrated that trastuzumab deruxtecan (T-DXd) significantly improves survival in patients with HER2-negative metastatic breast cancer, including those with low HER2 expression, which was previously thought to be untreatable.
This trial is prompting a reevaluation of treatment strategies for HER2-low breast cancer, highlighting the need for ongoing clinical trials to address emerging challenges and evidence gaps in this area.
Targeting HER2-low in metastatic breast cancer: an evolving treatment paradigm.Yang, C., Brezden-Masley, C., Joy, AA., et al.[2023]
Trastuzumab emtansine (T-DM1) is an innovative antibody-drug conjugate that effectively targets HER2-positive breast cancer cells, showing improved safety and efficacy compared to standard chemotherapy in a Phase II trial.
In a Phase III trial, T-DM1 demonstrated significantly longer progression-free and overall survival in patients previously treated with trastuzumab, marking a significant advancement in targeted breast cancer therapy.
Trastuzumab emtansine: the first targeted chemotherapy for treatment of breast cancer.Peddi, PF., Hurvitz, SA.[2021]
Trastuzumab has significantly improved outcomes for patients with HER2-positive breast cancer, making their survival rates comparable to those with luminal tumors, and the current first-line treatment involves a combination of pertuzumab and trastuzumab with a taxane.
Newly approved drugs like tucatinib and trastuzumab deruxtecan offer promising options for patients whose cancer has progressed after standard treatments, highlighting the need for personalized treatment strategies and understanding drug resistance mechanisms.
HER2-positive metastatic breast cancer: a comprehensive review.Exman, P., Tolaney, SM.[2021]

References

Targeting HER2-low in metastatic breast cancer: an evolving treatment paradigm. [2023]
Trastuzumab emtansine: the first targeted chemotherapy for treatment of breast cancer. [2021]
HER2-positive metastatic breast cancer: a comprehensive review. [2021]
Association Between Biomarkers and Clinical Outcomes of Pembrolizumab Monotherapy in Patients With Metastatic Triple-Negative Breast Cancer: KEYNOTE-086 Exploratory Analysis. [2023]
Antibody-drug conjugates, immune-checkpoint inhibitors, and their combination in breast cancer therapeutics. [2022]
Recent developments in treatment stratification for metastatic breast cancer. [2021]
Current treatment landscape for patients with locally recurrent inoperable or metastatic triple-negative breast cancer: a systematic literature review. [2020]
Atezolizumab in the treatment of metastatic triple-negative breast cancer. [2021]
Landmark trials in the medical oncology management of metastatic breast cancer. [2022]
Atezolizumab for the treatment of breast cancer. [2021]