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Hormone Therapy

Zanidatamab + Palbociclib + Fulvestrant for Breast Cancer

Phase 2
Waitlist Available
Research Sponsored by Zymeworks Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Adequate cardiac left ventricular function, as defined by left ventricular ejection fraction (LVEF) >/= institutional standard of normal
Must not have
Grade 2 or greater pneumonitis and/or interstitial lung disease, including pulmonary fibrosis, or other clinically significant infiltrative pulmonary disease not related to lung metastases
Grade 3 or greater peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months from first dose of any study drug to the date of documented disease progression or death
Awards & highlights

Summary

This trial is testing a new cancer drug combo to see if it's safe & effective. It's for people with HER2+ breast cancer.

Who is the study for?
This trial is for adults with advanced breast cancer that's both HER2-positive and hormone receptor-positive. They must have tried certain other treatments like trastuzumab without success, be in good physical condition (ECOG score of 0 or 1), and have no serious heart, lung, liver, or nervous system problems. People with active hepatitis B/C, HIV not well-controlled, recent heart attacks or unstable angina are excluded.
What is being tested?
The study tests ZW25 (zanidatamab) combined with palbociclib plus fulvestrant to see how safe it is and how well it works against this type of breast cancer. It's an open-label Phase 2a trial where everyone knows what treatment they're getting.
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea, diarrhea, low blood cell counts increasing infection risk; liver issues; potential heart problems like changes in heartbeat rhythm; and possible nerve damage leading to numbness or tingling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My heart pumps blood well, meeting the normal standards.
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My breast cancer is advanced, cannot be surgically removed, and is HER2 and hormone receptor positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe lung inflammation or scarring not caused by cancer spread.
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I do not have severe nerve damage in my hands or feet.
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I haven't had a heart attack, unstable chest pain, or serious heart issues in the last 6 months.
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I have an active hepatitis B or C infection.
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I have or had cancer spread to the lining of my brain and spinal cord.
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I haven't had cancer treatment or hormonal therapy in the last 3 weeks.
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I do not have severe kidney, pancreas, or liver disease.
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I have previously been treated with drugs targeting CDK4/6.
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I have another cancer that could affect the study treatment's safety or results.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months from first dose of any study drug to the date of documented disease progression or death
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months from first dose of any study drug to the date of documented disease progression or death for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events
Number of Participants With Dose-Limiting Toxicities
Progression-free Survival 6
Secondary study objectives
Number of Participants Reporting Any Treatment-emergent Adverse Event, Serious Adverse Event, and Adverse Event of Special Interest

Side effects data

From 2024 Phase 2 trial • 87 Patients • NCT04466891
49%
Diarrhea
34%
Infusion related reaction
23%
Anemia
20%
Alanine aminotransferase increased
19%
Aspartate aminotransferase increased
19%
Abdominal pain
18%
Nausea
16%
Decreased appetite
16%
Pyrexia
15%
Vomiting
14%
Ejection fraction decreased
14%
Fatigue
14%
Pruritis
14%
Hypokalemia
14%
Weight decreased
13%
Hypertension
11%
Blood bilirubin increased
9%
Abdominal pain upper
9%
Blood alkaline phosphatase increased
9%
Rash
9%
Dizziness
8%
Asthenia
8%
Blood creatinine increased
8%
Hypoalbuminemia
8%
Urinary tract infection
8%
Gamma-glutamyltransferase increased
6%
Peripheral sesory neuropathy
6%
Constipation
6%
Dyspepsia
6%
Oedema peripheral
6%
Hypomagnesemia
6%
Jaundice cholestatic
5%
Pneumonia
5%
Biliary obstruction
5%
Sepsis
5%
Ascites
4%
Drug hypersensitivity
4%
Cholangitis
4%
Obstruction gastric
4%
Platelet count decreased
4%
Hyponatremia
3%
Epistaxis
3%
Bacteremia
3%
Jaundice
1%
Pneumonitis
1%
Syncope
1%
Duodenal ulcer
1%
COVID-19
1%
Pseudomembranous colitis
1%
Acute kidney injury
1%
Large intestinal obstruction
1%
Malnutrition
1%
Hemangioma
1%
Bile duct stenosis
1%
Hepatic failure
1%
Gastric ulcer
1%
Haematemesis
1%
Hypochloraemia
1%
Biliary tract infection
1%
Upper gastrointestinal hemorrhage
1%
Paraneoplastic syndrome
1%
Ileus
1%
Cholangiocarcinoma
1%
Abdominal lymphadenopathy
1%
Feces discolored
1%
Small intestinal obstruction
1%
Pneumothorax
1%
Procedural pain
1%
Hypoproteinemia
1%
Pollakiuria
1%
Oral candidiasis
1%
Device related infection
1%
Liver abscess
1%
Duodenal stenosis
1%
Duodenal obstruction
1%
Pancreatitis
1%
Pleural effusion
1%
Aortic aneurysm
1%
Cholecystitis
1%
Cholangitis infective
1%
Enteritis
1%
Cerebrovascular accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort I
Cohort II

Trial Design

1Treatment groups
Experimental Treatment
Group I: ZW25 (zanidatamab) + palbociclib + fulvestrantExperimental Treatment3 Interventions
ZW25 (zanidatamab) plus palbociclib, fulvestrant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~3880
ZW25 (Zanidatamab)
2020
Completed Phase 2
~90
Fulvestrant
2011
Completed Phase 3
~3890

Find a Location

Who is running the clinical trial?

Zymeworks Inc.Lead Sponsor
10 Previous Clinical Trials
2,421 Total Patients Enrolled
1 Trials studying Breast Cancer
20 Patients Enrolled for Breast Cancer
Jazz PharmaceuticalsLead Sponsor
249 Previous Clinical Trials
34,884 Total Patients Enrolled
Elaina Gartner, MDStudy DirectorZymeworks Inc.
3 Previous Clinical Trials
94 Total Patients Enrolled

Media Library

Fulvestrant (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04224272 — Phase 2
Breast Cancer Research Study Groups: ZW25 (zanidatamab) + palbociclib + fulvestrant
Breast Cancer Clinical Trial 2023: Fulvestrant Highlights & Side Effects. Trial Name: NCT04224272 — Phase 2
Fulvestrant (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04224272 — Phase 2
~10 spots leftby Sep 2025
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