Zanidatamab for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast Cancer+1 MoreZanidatamab - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is for patients with early stage, low risk HER2+ BC. The objective is to see if zanidatamab is effective in treating the cancer, as determined by pathologic complete response.

Eligible Conditions
  • Breast Cancer
  • HER2 Positive

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 0 Secondary · Reporting Duration: through study completion, an average of 1 year

Year 1
To determine the efficacy of zanidatamab for patients with early stage HER2/neu positive (HER2+) breast cancer (BC) as determined by pathologic complete response (pCR

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
ZW49
1
Talimogene Laherparepvec
1
MDM2/MDMX Inhibitor ALRN-6924

Trial Design

1 Treatment Group

Zanidatamab
1 of 1

Experimental Treatment

17 Total Participants · 1 Treatment Group

Primary Treatment: Zanidatamab · No Placebo Group · Phase 2

ZanidatamabExperimental Group · 3 Interventions: Tamoxifen, Zanidatamab, Letrozole · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamoxifen
FDA approved
Letrozole
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year

Who is running the clinical trial?

Zymeworks Inc.Industry Sponsor
10 Previous Clinical Trials
2,633 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,354 Total Patients Enrolled
141 Trials studying Breast Cancer
31,183 Patients Enrolled for Breast Cancer
Vicente ValeroPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
819 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
ECHO or MUGA scan must be performed within 4 weeks prior to first dose of study drug.
Patients with HER2+ BC may have ER+ or ER- disease.
You have an absolute neutrophil count (ANC) of at least 1.
Platelet count ≥ 100 x 109/L (≥100,000 per mm3).
References

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