Trial 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
NCT ID:
NCT06435429
Condition:
Metastatic HER2-positive Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Gemcitabine
Capecitabine
Trastuzumab
Vinorelbine
Conditions: Keywords:
Zanidatamab
Trastuzumab
Metastatic HER2-positive breast cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Zanidatamab
Description:
Administered by intravenous infusion
Arm group label:
Zanidatamab plus physician's choice of chemotherapy
Intervention type:
Drug
Intervention name:
Trastuzumab
Description:
Administered by intravenous infusion
Arm group label:
Trastuzumab plus physician's choice of chemotherapy
Intervention type:
Drug
Intervention name:
Eribulin
Description:
Administered by intravenous infusion
Arm group label:
Trastuzumab plus physician's choice of chemotherapy
Arm group label:
Zanidatamab plus physician's choice of chemotherapy
Intervention type:
Drug
Intervention name:
Vinorelbine
Description:
Administered by intravenous infusion
Arm group label:
Trastuzumab plus physician's choice of chemotherapy
Arm group label:
Zanidatamab plus physician's choice of chemotherapy
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Administered by intravenous infusion
Arm group label:
Trastuzumab plus physician's choice of chemotherapy
Arm group label:
Zanidatamab plus physician's choice of chemotherapy
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Given orally
Arm group label:
Trastuzumab plus physician's choice of chemotherapy
Arm group label:
Zanidatamab plus physician's choice of chemotherapy
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Participants are eligible to be included in the study only if all of the following
criteria apply:
1. Is 18 years of age or of the legal adult age per local standard at the time of
signing the informed consent.
2. Has histologically confirmed HER2-positive breast cancer according to ASCO-CAP
Guidelines as evaluated by a central laboratory
3. Participants with unresectable or metastatic HER2 positive breast cancer who have
progressed on, or are intolerant to, previous T-DXd treatment.
4. Has measurable disease per RECIST version 1.1.
5. Is eligible to receive one of the chemotherapy options listed in the physician's
choice of chemotherapy (eribulin, gemcitabine, vinorelbine, or capecitabine).
6. Participants with history of treated or clinically inactive CNS metastases are
eligible as specified in the protocol.
7. Has a life expectancy of at least 6 months, in the opinion of the investigator.
8. Has adequate hematologic parameters as defined in the protocol.
9. Has adequate hepatic function as specified in the protocol.
10. Has creatinine clearance ≥ 30 mL/minute as calculated per local institutional
guidelines.
11. Has LVEF ≥ 50% as determined by either echocardiogram or MUGA obtained within 4
weeks before the first dose of study intervention.
12. Has ECOG performance status of 0 or 1.
13. Participant agrees to the following based on sex assigned at birth.
1. Male participants:
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
2. 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 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.
14. 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 the following criteria apply:
Medical Conditions
1. Has known or suspected leptomeningeal disease.
2. Has uncontrolled or significant cardiovascular disease.
3. Has toxicity related to prior cancer therapy that has not resolved to ≤ Grade 1,
with exceptions as stated in the protocol.
4. Has uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
5. Has known HIV infection.
6. Has active hepatitis B or C infection.
7. Has an active SARS-CoV-2 infection. Participants with prior infection that has
resolved per local institutions' requirements and screening guidance are eligible.
8. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to
recombinant proteins or excipients in the drug formulation of zanidatamab.
9. Is unable to receive trastuzumab treatment due to medical contraindications.
10. 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.
11. Has any condition that would prevent treatment with the physician's choice of
chemotherapy.
12. 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
13. Has a history of prior allogeneic bone marrow, stem cell, or solid organ
transplantation.
14. 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.
15. Has a history of trauma or major surgery within 4 weeks prior to randomization.
Other Exclusions
16. Has a known hypersensitivity to any components of the study drugs, including
chemotherapy.
17. Female participants who are breastfeeding or pregnant, and female and male
participants planning a pregnancy.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arizona Oncology Tucson - Wilmot
Address:
City:
Tucson
Zip:
85711
Country:
United States
Status:
Recruiting
Facility:
Name:
Rocky Mountain Cancer Centers
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Minnesota Oncology Hematology
Address:
City:
Coon Rapids
Zip:
55433
Country:
United States
Status:
Recruiting
Facility:
Name:
Messino Cancer Center
Address:
City:
Asheville
Zip:
28806
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Hematology Care (OHC)
Address:
City:
Cincinnati
Zip:
45226
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology - Fort Worth
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Oncology Associates, Sentara Health
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Recruiting
Facility:
Name:
Blue Ridge Cancer Care
Address:
City:
Roanoke
Zip:
24014
Country:
United States
Status:
Recruiting
Start date:
August 13, 2024
Completion date:
November 26, 2031
Lead sponsor:
Agency:
Jazz Pharmaceuticals
Agency class:
Industry
Source:
Jazz Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06435429
