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Monoclonal Antibodies

Zanidatamab for Early Stage HER2 Positive Breast Cancer

Phase 2

Waitlist Available

Led By Vicente Valero

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tumor size > 1 cm to ≤ 3 cm assessed by ultrasound and clinically and radiographically node negative with no known metastatic disease

Age > 18 years at time of study entry

Must not have

Received therapy for the current diagnosis of BC including investigational therapy, endocrine therapy, targeted therapy, or chemotherapy, surgery or radiation

Uncontrolled intercurrent illness including ongoing or active infection, active peptic ulcer disease or gastritis, active bleeding diatheses, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

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.

Who is the study for?

This trial is for adults over 18 with early stage, low risk HER2+ breast cancer. Participants must have normal organ and marrow function, no prior BC treatments or other malignancies that could affect the study, and be able to consent. They should not be pregnant or breastfeeding and must use contraception if of reproductive potential.

What is being tested?

The trial tests Zanidatamab's effectiveness in treating early stage HER2+ breast cancer by looking at the complete response after treatment. It's a single-arm study where all participants receive Zanidatamab along with standard care drugs Tamoxifen or Letrozole.

What are the potential side effects?

Zanidatamab may cause side effects similar to other monoclonal antibodies such as allergic reactions, fatigue, nausea, diarrhea, liver enzyme changes, and possible heart issues. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is between 1 and 3 cm, with no spread to lymph nodes or other parts.

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I am older than 18 years.

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My heart's pumping ability is normal as shown by a recent heart scan.

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I am fully active or can carry out light work.

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My breast cancer is HER2 positive according to ASCO-CAP guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received some form of treatment for my current breast cancer diagnosis.

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I do not have any severe illnesses or mental health issues that would stop me from following the study rules.

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I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using effective birth control.

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My cancer has spread to distant parts of my body, including the brain.

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I have active Hepatitis B or C.

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I do not have uncontrolled kidney, pancreas, or liver disease.

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I had a lung clot symptom within the last 28 days.

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I have seizures that are not controlled by medication.

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I have received more than the maximum safe amount of a specific chemotherapy drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups

Experimental Treatment

Group I: ZanidatamabExperimental Treatment3 Interventions

zanidatamab by vein every 2 weeks (+/- 3 days) for up to 6 doses (3 study cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tamoxifen

2005

Completed Phase 4

~30110

Letrozole

2002

Completed Phase 4

~3590

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zymeworks BC Inc.Industry Sponsor

5 Previous Clinical Trials

1,296 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

3,041 Previous Clinical Trials

1,799,720 Total Patients Enrolled

147 Trials studying Breast Cancer

63,257 Patients Enrolled for Breast Cancer

Zymeworks Inc.Industry Sponsor

10 Previous Clinical Trials

2,452 Total Patients Enrolled

Media Library

Zanidatamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05035836 — Phase 2

Breast Cancer Research Study Groups: Zanidatamab

Breast Cancer Clinical Trial 2023: Zanidatamab Highlights & Side Effects. Trial Name: NCT05035836 — Phase 2

Zanidatamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05035836 — Phase 2

~2 spots leftby Dec 2024

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