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Zanidatamab + Palbociclib + Fulvestrant for Breast Cancer
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I've had specific treatments for my cancer and it has gotten worse despite them.I am fully active or restricted in physically strenuous activity but can do light work.My heart pumps blood well, meeting the normal standards.My breast cancer is advanced, cannot be surgically removed, and is HER2 and hormone receptor positive.I have severe lung inflammation or scarring not caused by cancer spread.My organs are working well.I do not have severe nerve damage in my hands or feet.I haven't taken any HER2-targeted cancer treatments in the last 3 weeks.The areas of disease can be measured and assessed using a specific set of guidelines.I have stable, treated brain metastases and have been off steroids and seizure medications for at least a month.I haven't had a heart attack, unstable chest pain, or serious heart issues in the last 6 months.I have an active hepatitis B or C infection.I have or had cancer spread to the lining of my brain and spinal cord.I haven't had cancer treatment or hormonal therapy in the last 3 weeks.I have HIV but it is well-controlled.I do not have severe kidney, pancreas, or liver disease.Your heart's electrical activity is too slow, measured by a specific test.I have previously been treated with drugs targeting CDK4/6.I have another cancer that could affect the study treatment's safety or results.
- Group 1: ZW25 (zanidatamab) + palbociclib + fulvestrant
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
In what clinical circumstances is Zanidatamab typically prescribed?
"Zanidatamab (ZW25) is often prescribed for malignant neoplasms and additional diagnosis such as pik3ca gene mutation, progression of the illness, and post endocrine therapy."
How many participants have signed up for this research initiative?
"This research project is not presently enrolling participants. Initially posted on June 10, 2020 and most recently updated November 17th 2022, it has concluded its recruitment phase. There are currently 2287 clinical trials seeking patients with breast cancer and 240 studies recruiting volunteers to test the efficacy of Zanidatamab (ZW25)."
How many physical sites are currently implementing this research project?
"Patients can be enrolled in this clinical trial at Sunnybrook Research Institute of Toronto, Ontario; The Ottawa Hospital Cancer Centre of Ottawa Washington; and Seattle Cancer Care Alliance of Seattle California. This study is additionally enrolling participants from seven other locations."
Has Zanidatamab received regulatory acknowledgment from the FDA?
"ZW25 (Zanidatamab) falls into the safety range of 2 due to limited clinical data supporting its efficacy, however there is a moderate degree of evidence attesting to its security."
Are there any vacancies currently available to join this experiment?
"According to the information on clinicaltrials.gov, this trial is no longer recruiting patients at this time; it was initially posted in June 2020 and last amended in November 2022. Nevertheless, there are 2527 other studies with active recruitment now occurring."
Are there any other experiments involving Zanidatamab (ZW25) that have been conducted?
"Zanidatamab (ZW25) was initially studied at Lowell General Hospital in 2004. Since then, 153 trials have been concluded and there are presently 240 ongoing studies; Toronto has a great concentration of these active clinical investigations."
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