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Compares treatment options for Metastatic HER2-positive Breast Cancer
Official title A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer
ClinicalTrials.gov ID: NCT06435429
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 metastatic her2-positive breast cancer.
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 efficacy and safety of zanidatamab in combination with physician's choice of chemotherapy compared with trastuzumab in combination with physician's choice of chemotherapy will be evaluated for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.
- Phase 3: a large, late-stage study
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
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Is 18 years of age or of the legal adult age per local standard at the time of signing the informed consent.
- Has histologically confirmed HER2-positive breast cancer according to ASCO-CAP Guidelines as evaluated by a sponsor-designated central laboratory
- Participants with unresectable or metastatic HER2 positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.
- Must have received at least 2 lines of HER2-directed therapy for their metastatic disease.
See the full eligibility criteria
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Is 18 years of age or of the legal adult age per local standard at the time of signing the informed consent.
- Has histologically confirmed HER2-positive breast cancer according to ASCO-CAP Guidelines as evaluated by a sponsor-designated central laboratory
- Participants with unresectable or metastatic HER2 positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.
- Must have received at least 2 lines of HER2-directed therapy for their metastatic disease.
- Prior HER2-targeted neo-adjuvant or adjuvant therapy that resulted in relapse within 6 months of the completion of therapy will be considered a line of treatment for metastatic disease.
- Based on the physician's choice, participants' eligibility, and institutional and local guidelines, participants may also have received post-T-DXd therapy, for example, a tucatinib-based regimen and/or T-DM1.
- Participants must not have received more than 4 lines of HER2-directed therapy in the metastatic setting.
- Has measurable disease per RECIST version 1.1.
- Is eligible to receive one of the chemotherapy options listed in the physician's choice of chemotherapy (eribulin, gemcitabine, vinorelbine, or capecitabine).
- Participants with history of treated or clinically inactive CNS metastases are eligible as specified in the protocol.
- Has a life expectancy of at least 6 months, in the opinion of the investigator.
- Has adequate hematologic parameters as defined in the protocol.
- Has adequate hepatic function as specified in the protocol.
- Has creatinine clearance ≥ 50 mL/minute as calculated per local institutional guidelines.
- Has LVEF ≥ 50% as determined by either echocardiogram or MUGA obtained within 4 weeks before the first dose of study intervention.
- Has ECOG performance status of 0 or 1.
- Participant agrees to the following based on sex assigned at birth.
- Male participants: Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 7 months after the last dose of study intervention or the...
- Refrain from donating fresh unwashed semen.
- Use contraception as follows as specified in the protocol
- Female participants:
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- Is a women of nonchildbearing potential OR
- Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of \< 1% per year), with low user dependency during the study intervention period and for at...
- A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 3 days before the first dose of study intervention.
- Additional requirements for pregnancy testing during and after study intervention are provided in the protocol.
- The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocol. Participants are excluded from the study if any of...
- Has clinically confirmed leptomeningeal disease, in the opinion of the investigator.
- Has uncontrolled or significant cardiovascular disease.
- Has toxicity related to prior cancer therapy that has not resolved to ≤ Grade 1, with exceptions as stated in the protocol.
- Has uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- Has an infection with HIV-1 or HIV-2, with the exception of participants with well-controlled HIV.
- Has active hepatitis B or C infection.
- Has an active SARS-CoV-2 infection. Participants with prior infection that has resolved per local institutions' requirements and screening guidance are eligible.
- Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab.
- Is unable to receive trastuzumab treatment due to medical contraindications.
- Has any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site.
- Has any condition that would prevent treatment with the physician's choice of chemotherapy.
- Has any issue or condition that in the opinion of the investigator would contraindicate the participant's participation in the study or confound the results of the study. Prior/Concomitant Therapy
- Has a history of prior allogeneic bone marrow, stem cell, or solid organ transplantation.
- The washout periods for prior anticancer therapies before randomization as specified in the protocol.
- Has a history of trauma or major surgery within 4 weeks prior to randomization. Other Exclusions
- Has a known hypersensitivity to any components of the study drugs, including chemotherapy.
- Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Cerritos, California, United States
- Glendale, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Fort Myers, Florida, United States
- Jacksonville, Florida, United States
- St. Petersburg, Florida, United States
- West Palm Beach, Florida, United States
- Boston, Massachusetts, United States
- Coon Rapids, Minnesota, United States
- Rochester, Minnesota, United States
- Kansas City, Missouri, United States
- Hackensack, New Jersey, United States
- New Brunswick, New Jersey, United States
- Long Island City, New York, United States
+ 116 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 Phoenix, Arizona, United States; Tucson, Arizona, United States; Cerritos, California, United States; Glendale, California, United States; Los Angeles, California, United States; San Francisco, California, United States and 130 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.