Last updated 6 months ago
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
550 patients around the world
Available in Brazil, United States
Zanidatamab, as a monotherapy or in combination with other antineoplastic agents, has shown clinically meaningful efficacy against multiple HER2-positive advanced/metastatic tumors, including in patients with metastatic breast cancer (mBC). Zanidatamab may offer a viable treatment option for patients with metastatic HER2-positive breast cancer.
The primary objective of the study is to compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy. The secondary objectives of the study will include further comparing the efficacy, safety and tolerability, patient-reported tolerability, and patient-reported physical functioning of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy. The pharmacokinetics and immunogenicity of zanidatamab in combination with chemotherapy will also be evaluated.
Jazz Pharmaceuticals
4Research sites
550Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 central laboratory.Participants with unresectable or metastatic HER2 positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.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 ≥ 30 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 are eligible to participate if they agree to the following during the study intervention period and for at least 5 months after the last dose of study intervention or the contraception period for the combination chemotherapy of choice per local guidance/standard practice, whichever is longer.Refrain from donating fresh unwashed semen.Use contraception as follows as specified in the protocol.A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies.Is a woman of nonchildbearing potential.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 least 5 months after the last dose of study intervention or the contraception period for the combination chemotherapy of choice per local guidance/standard practice, whichever is longer.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.
- Has known or suspected leptomeningeal disease.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 known HIV infection.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.Has a history of prior allogeneic bone marrow, stem cell, or solid organ transplantation.Was treated with any local or systemic antineoplastic therapy (including hormonal therapies for breast cancer) or any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to randomization.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.
Sites
Hospital Brasília
Recruiting
Centro Regional Integrado de Oncologia - CRIO
Recruiting
Real Hospital Português de Beneficência em Pernambuco
Recruiting
Ceon+ Centro de Oncologia
Recruiting
SponsorJazz Pharmaceuticals
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06435429
