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A Phase 3, randomized, open-label, multicenter, controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician’s choice chemotherapy compared to trastuzumab in combination with physician’s choice chemotherapy for the treatment (EmpowHER 303)
EU CTIS ID: 2023-508960-31-00
What this study is testing
Compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Is 18 years of age or of the legal adult age per local standard at the time of signing the informed consent.
- 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
- Has a life expectancy of at least 6 months, in the opinion of the investigator.
- Has adequate hematologic parameters
You likely can't join if
- Has clinically confirmed leptomeningeal disease, in the opinion of the investigator.
- 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
- Has a history of prior allogeneic bone marrow, stem cell, or solid organ transplantation.
- Has a history of trauma or major surgery within 4 weeks prior to randomization.
See the full eligibility criteria
Who can join
- Is 18 years of age or of the legal adult age per local standard at the time of signing the informed consent.
- 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
- Has a life expectancy of at least 6 months, in the opinion of the investigator.
- Has adequate hematologic parameters
- Has adequate hepatic function
- Must have received at least 2 lines of HER2-directed therapy for their metastatic disease
- Has creatinine clearance ≥ 50 mL/minute as calculated per local institutional guidelines.
- Has LVEF ≥ 55% 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.
- 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 contraception period for the combination chemotherapy of choice per local guidance/standard practice. This requirement aligns with the contraception period recommended for trastuzumab and is longer than the recommended contraception period for zanidatamab, which is 4 months, and for all other allowed chemotherapy options.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: - Is a WONCBP; - Is a WOCBP and using a contraceptive method that is highly effective during the study intervention period and for at least 7 months after the last dose of study intervention. This requirement aligns with the contraception period recommended for trastuzumab and is longer than the recommended contraception period for zanidatamab, which is 5 months, and for all other allowed chemotherapy options. Therefore, 7 months is considered sufficient to collect details of all pregnancies.
- Is capable of giving signed informed consent
- Has histologically confirmed HER2-positive breast cancer according to ASCO–CAP Guidelines as evaluated by a sponsor-designated central laboratory (Wolff, 2018)
- Participants with unresectable or metastatic HER2 positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.
What rules you out
- Has clinically confirmed leptomeningeal disease, in the opinion of the investigator.
- 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
- Has a history of prior allogeneic bone marrow, stem cell, or solid organ transplantation.
- Has a history of trauma or major surgery within 4 weeks prior to randomization.
- 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 washout periods for prior anticancer therapies before randomization are as follows: a. Prior therapies with monoclonal antibodies including ADCs: washout period ≤ 3 weeks b. Prior therapies with small molecule targeted therapies: washout period of ≤ 2 weeks or 5 half-lives, whichever is shorter c. No washout period needed for endocrine therapy. − No washout period for gonadotropin-releasing hormone agonists.
- Prior participation in a zanidatamab clinical study.
- Receipt of a live vaccine within 4 weeks prior to enrollment.
- Has uncontrolled or significant cardiovascular disease
- Participants known to have a complete lack of the enzyme dihydropyrimidine dehydrogenase who are assigned to receive chemotherapy capecitabine in combination with the study treatment.
- Primary cancer in the previous 3 years prior to randomization, except non-melanoma skin cancer/in situ disease.
- Has toxicity related to prior cancer therapy that has not resolved to ≤ Grade 1
- Has uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- Has an infection with HIV-1 or HIV-2. (Exception: Participants with well‑controlled HIV [ie, CD4 > 350/mm3 and undetectable viral load] are eligible.)
- Has active hepatitis B or C infection.
- Has an active SARS-CoV-2 infection.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Brazil
- Korea, Republic of
- United Kingdom
- Canada
- Australia
- United States
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Brazil; Korea, Republic of; United Kingdom; Canada; Australia and 1 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 EU CTIS; the study team decides eligibility.