Zanidatamab with Chemotherapy for HER2-positive Breast Cancer

A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

Recruiting Phase 2 Interventional Study
HER2-positive Breast Cancer Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
125 (estimated)
Sponsor
Jazz Pharmaceuticals · Industry
Who this trial is looking for

This trial is looking for people with early-stage HER2-positive breast cancer to see if zanidatamab combined with chemotherapy is safe and effective. Participants will need to undergo surgery after the treatment.

Are You a Good Fit for This Trial?
Rules you out Uncontrolled hypertensionPeripheral neuropathyActive infectionHypersensitivity to monoclonal antibodiesActive hepatitis B or C

You may be able to join if

  • I have newly diagnosed Stage II or III breast cancer.
  • I have HER2-positive breast cancer.
  • I have known hormone receptor status for my tumor.
  • I agree to have surgery after treatment.
  • I can perform daily activities with little to no assistance.
  • I have good heart function.
  • I use effective birth control.
  • I have a CD4+ T Cell count above 350 microliters.

You may not be able to join if

  • I have Stage IV breast cancer.
  • I have bilateral breast cancer.
  • I have uncontrolled high blood pressure.
  • I have significant nerve pain.
  • I have an uncontrolled infection.
  • I have had severe allergic reactions to monoclonal antibodies.
  • I have a history of active hepatitis B or C.
  • I recently received a live vaccine.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: 1. Has newly diagnosed Stage II or III histologically confirmed invasive breast carcinoma. 2. Has histologically confirmed HER2-positive breast cancer 3. Has a known hormone receptor (HR) status of the primary tumor 4. Participants with multifocal or multicentric disease are eli…
Contacts

Clinical Trial Disclosure & Transparency

215-832-3750

ClinicalTrialDisclosure@JazzPharma.com

CONTACT