Zanidatamab for Early Stage HER2 Positive Breast Cancer

Overseen By Vicente Valero, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Concurrent malignancy, Cardiac disease, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 2, single-site, single-arm open-label trial of zanidatamab in patients with early stage, low risk HER2+ BC. The primary objective is 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) .

Research Team

Vicente Valero, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

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

I am older than 18 years.

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

Exclusion Criteria

Your heart's electrical activity (QT interval) is too long.

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

I do not have serious heart problems like recent heart attacks or uncontrolled high blood pressure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zanidatamab by vein every 2 weeks for up to 6 doses

12 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Zanidatamab

Trial Overview 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.

Participant Groups

Group I: Zanidatamab Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Zymeworks BC Inc.

Industry Sponsor

Trials

6

Recruited

1,300+

Zymeworks Inc.

Industry Sponsor

Trials

11

Recruited

2,400+