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Zanidatamab for Early Stage HER2 Positive Breast Cancer
Study Summary
This trial is for patients with early stage, low risk HER2+ BC. The objective is to see if zanidatamab is effective in treating the cancer, as determined by pathologic complete response.
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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- Your heart's electrical activity (QT interval) is too long.I have received some form of treatment for my current breast cancer diagnosis.My tumor is between 1 and 3 cm, with no spread to lymph nodes or other parts.I am older than 18 years.My heart's pumping ability is normal as shown by a recent heart scan.I do not have serious heart problems like recent heart attacks or uncontrolled high blood pressure.I am fully active or can carry out light work.You need to have a negative pregnancy test within 3 days before starting the zanidatamab treatment.I am willing to have surgery if it's recommended for me.I haven't taken steroids or immunosuppressants in the last 2 weeks.You have had a severe allergic reaction to monoclonal antibodies or similar drugs in the past.I do not have any severe illnesses or mental health issues that would stop me from following the study rules.I don't have any other cancers that could affect this treatment's safety or results.I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using effective birth control.I have not received a live vaccine in the last 4 weeks.I have not had any major surgery in the last 4 weeks, except for a portacath placement.My cancer has spread to distant parts of my body, including the brain.I have active Hepatitis B or C.I do not have uncontrolled kidney, pancreas, or liver disease.I had a lung clot symptom within the last 28 days.My blood tests for organ function and blood cell counts are within normal ranges.My breast cancer is HER2 positive according to ASCO-CAP guidelines.I have seizures that are not controlled by medication.You have HIV.I have received more than the maximum safe amount of a specific chemotherapy drug.
- Group 1: Zanidatamab
- 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
What is the current enrollment of this research project?
"Affirmative. According to the clinicaltrials.gov, this research project published on November 16th 2021 is still actively looking for subjects. Seventeen volunteers must be recruited from a single location in order to meet the requirements of the trial."
What prior investigations have featured Zanidatamab as a primary treatment?
"Currently, 189 clinical trials are running regarding Zanidatamab. Of those live studies, 51 have reached the Phase 3 stage of testing. With a primary focus in San Francisco, California, there are 11 947 medical centres worldwide that offer this treatment as part of their investigations."
Are there any available slots left in this clinical experiment?
"Clinicaltrials.gov confirms that this trial, which was initiated on November 16th 2021, is actively registering participants. The study's details were last updated in October 2022."
What indications is Zanidatamab typically utilized to treat?
"Zanidatamab is a therapeutic agent used for treating breast surgery, cancerous breasts, and estrogen receptor-positive malignancy."
Has the FDA authorized Zanidatamab for medical deployment?
"With limited evidence of efficacy, but some proof of safety, our team has ascribed Zanidatamab a score of 2 on the risk scale."
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