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ARV-471 + Everolimus for Advanced Breast Cancer (TACTIVE-E Trial)
TACTIVE-E Trial Summary
This trial is testing a new combination drug treatment for advanced breast cancer.
TACTIVE-E Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTACTIVE-E Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TACTIVE-E Trial Design
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Who is running the clinical trial?
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- I have not had a heart attack, severe chest pain, stroke, or significant blood clot in the last year.I have not had serious heart rhythm problems in the last 6 months.I have been treated with drugs targeting mTOR.You have a disease that can be measured or evaluated according to specific guidelines.I have had lung problems caused by medication before.I've had 1-3 treatments for advanced cancer, including a CDK 4/6 inhibitor and hormone therapy.I haven't taken any cancer drugs or been in a study within the last 4 weeks.I am a woman who is either postmenopausal or taking medication to suppress my ovaries.I haven't had radiation therapy in the last 4 weeks or to more than 25% of my bone marrow.I haven't taken any cancer drugs or experimental treatments in the last 28 days.I have previously been treated with ARV-471.I do not have any active, uncontrolled infections including HIV/AIDS or hepatitis.My high blood pressure is not controlled by medication.I have not had major surgery within the last 4 weeks.I am willing to use a special mouthwash to prevent mouth sores from my medication.I have brain metastases not treated or need high doses of steroids.I have not received any live vaccines in the last 14 days.My breast cancer is ER+ and HER2-, and cannot be removed by surgery.I am fully active or can carry out light work.
- Group 1: ARV-471 and Everolimus
- 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
How many different sites are implementing this research project?
"Currently, this research is occurring in 5 different settings. Nashville, Santa Monica and Lake Mary are some of the cities that have a trial site as well as other locations. If you choose to take part, it is recommended to opt for one closest to your residence so travelling demands can be minimised."
Is this trial actively seeking new participants?
"Affirmative. According to the clinicaltrials.gov website, this investigation is currently recruiting participants. It was first registered on September 8th 2022 and last updated October 18th 2022, with a need for 32 patients distributed among 5 health care centres."
How many subjects are currently involved in this clinical experiment?
"Affirmative. Clinicaltrials.gov reveals that this experiment, which was made available on September 8th 2022, is presently recruiting participants. 32 individuals must be recruited from 5 distinct medical facilities."
To what degree is the combination of ARV-471 and Everolimus hazardous for individuals?
"The combined efficacy and safety of ARV-471 in conjunction with Everolimus has not been widely studied, so the score assigned by our team is a 1."
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