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 2Interventional Study
HER2-positive Breast CancerBreast 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 outUncontrolled 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.
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
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Status
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…
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 eligible if the largest tumor (which must be larger than or equal to 2 cm in diameter) is HER2-positive, and the treating physician has determined the participant should be treated as HER2-positive.
5. Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy.
6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Adequate organ function
8. Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 6 weeks prior to randomization.
9. Adequate contraceptive precautions
10. Participants with known HIV are eligible unless:
1. CD4+ T Cell count is less than or equal to 350 microliters (uL)
2. Detectable viral load, or
3. Receiving protease inhibitors or cobicistat
Exclusion Criteria:
1. Has Stage IV (metastatic) breast cancer.
2. Has bilateral breast cancer.
3. Has a history of any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the participant's involvement in the study.
4. Has uncontrolled hypertension
5. Has significant symptoms from peripheral neuropathy
6. Has an active uncontrolled infection
7. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab or other study interventions.
8. Known active hepatitis B or C infection.
9. Has another malignancy diagnosed within the last 5 years. Exceptions include previously treated non melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ. Participants with prior ipsilateral ductal carcinoma in situ (DCIS) or invasive breast cancer are not eligible.
10. Was treated with surgery, chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer
11. Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol
12. Receipt of a live vaccine within 4 weeks prior to enrollment
13. Has a known hypersensitivity to any components of the study interventions, including chemotherapy
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