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New treatment option for HER2-positive Breast Cancer
Official title A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
ClinicalTrials.gov ID: NCT07102381
What this study is testing
What is Zanidatamab?
Zanidatamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for her2-positive breast cancer.
Also referred to as ZW25, JZP598.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has newly diagnosed Stage II or III histologically confirmed invasive breast carcinoma.
- Has histologically confirmed HER2-positive breast cancer
- Has a known hormone receptor (HR) status of the primary tumor
- 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...
- Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy.
You likely can't join if
- Has Stage IV (metastatic) breast cancer.
- Has bilateral breast cancer.
- Has a history of any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the...
- Has uncontrolled hypertension
- Has significant symptoms from peripheral neuropathy
- Has an active uncontrolled infection
See the full eligibility criteria
- Has newly diagnosed Stage II or III histologically confirmed invasive breast carcinoma.
- Has histologically confirmed HER2-positive breast cancer
- Has a known hormone receptor (HR) status of the primary tumor
- 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...
- Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function
- Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 6 weeks prior to randomization.
- Adequate contraceptive precautions
- Participants with known HIV are eligible unless:
- CD4+ T Cell count is less than or equal to 350 microliters (uL)
- Detectable viral load, or
- Receiving protease inhibitors or cobicistat
- Has Stage IV (metastatic) breast cancer.
- Has bilateral breast cancer.
- 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.
- Has uncontrolled hypertension
- Has significant symptoms from peripheral neuropathy
- Has an active uncontrolled infection
- 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.
- Known active hepatitis B or C infection.
- 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...
- Was treated with surgery, chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer
- Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol
- Receipt of a live vaccine within 4 weeks prior to enrollment
- Has a known hypersensitivity to any components of the study interventions, including chemotherapy
The study team makes the final eligibility decision.
Where it's taking place
- Long Beach, California, United States
- Los Alamitos, California, United States
- Denver, Colorado, United States
- Fort Lauderdale, Florida, United States
- Lakeland, Florida, United States
- Ames, Iowa, United States
- Shreveport, Louisiana, United States
- Scarborough, Maine, United States
- Laurel, Maryland, United States
- Lincoln, Nebraska, United States
- Omaha, Nebraska, United States
- East Brunswick, New Jersey, United States
- Newark, New Jersey, United States
- Albuquerque, New Mexico, United States
- Camillus, New York, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Long Beach, California, United States; Los Alamitos, California, United States; Denver, Colorado, United States; Fort Lauderdale, Florida, United States; Lakeland, Florida, United States; Ames, Iowa, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.