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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

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.

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.Check my eligibility
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.See study design
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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I am willing to have surgery if it's recommended for me.
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My blood tests for organ function and blood cell counts are within normal ranges.
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My breast cancer is HER2 positive according to ASCO-CAP guidelines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 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
~29860
Letrozole
2002
Completed Phase 4
~3240

Find a Location

Who is running the clinical trial?

Zymeworks BC Inc.Industry Sponsor
3 Previous Clinical Trials
991 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,429 Total Patients Enrolled
147 Trials studying Breast Cancer
63,266 Patients Enrolled for Breast Cancer
Zymeworks Inc.Industry Sponsor
10 Previous Clinical Trials
2,289 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment of this research project?

"Affirmative. According to the clinicaltrials.gov, this research project published on November 16th 2021 is still actively looking for subjects. Seventeen volunteers must be recruited from a single location in order to meet the requirements of the trial."

Answered by AI

What prior investigations have featured Zanidatamab as a primary treatment?

"Currently, 189 clinical trials are running regarding Zanidatamab. Of those live studies, 51 have reached the Phase 3 stage of testing. With a primary focus in San Francisco, California, there are 11 947 medical centres worldwide that offer this treatment as part of their investigations."

Answered by AI

Are there any available slots left in this clinical experiment?

"Clinicaltrials.gov confirms that this trial, which was initiated on November 16th 2021, is actively registering participants. The study's details were last updated in October 2022."

Answered by AI

What indications is Zanidatamab typically utilized to treat?

"Zanidatamab is a therapeutic agent used for treating breast surgery, cancerous breasts, and estrogen receptor-positive malignancy."

Answered by AI

Has the FDA authorized Zanidatamab for medical deployment?

"With limited evidence of efficacy, but some proof of safety, our team has ascribed Zanidatamab a score of 2 on the risk scale."

Answered by AI
~5 spots leftby Dec 2024