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Endocrine Therapy + CDK4/6 Inhibitor for Breast Cancer
Study Summary
This trial is studying if a CDK4/6 inhibitor combined with endocrine therapy can help treat subjects with ER+ and/or PR+ metastatic 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 haven't had any other cancers in the last 5 years, except for skin cancer or in situ cancer.I have tissue from a metastatic site collected in the last 6 months.I am about to start or am currently on my first treatment with ET and palbociclib for advanced cancer.My breast cancer is advanced or has spread to other parts of my body.My cancer is positive for ER/PR and negative for HER2.I can take care of myself and am up and about more than half of my waking hours.I am premenopausal or a man and am receiving LHRH agonist treatment.I am 18 years old or older.You have a disease that can be measured or evaluated.
- Group 1: Cohort A: Participants with untreated metastatic disease receiving ET and a CDK 4/6
- Group 2: Cohort B: Participants initiating a CDK 4/6 i after progression on ET.
- 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
Are seniors being accepted into the research project?
"Based on the qualifications outlined in this study, candidates must be over 18 years of age and younger than 100."
Are there still openings to join this trial?
"The clinical trial website states that this study is presently enrolling participants. It was first advertised on July 20th 2018 and the most recent update to its information occured on July 18th 2022."
Is Endocrine Therapy coupled with a CDK 4/6 inhibitor deemed safe for the patient demographic?
"We have assigned Endocrine Therapy and a CDK 4/6 inhibitor an overall safety rating of 2, as this is the second-phase trial. While there are data supporting its safety, efficacy has yet to be established."
How many individuals are actively contributing to the research endeavor?
"Affirmative. Clinicaltrials.gov attests to the ongoing recruitment for this trial, which was initially posted on July 20th 2018 and subsequently modified on July 18th 2022. This research is looking to enrol 100 volunteers at 2 distinct medical facilities."
Am I eligible to join this experimental trial?
"This medical trial seeks 100 individuals suffering from breast cancer, with ages ranging between 18 and 100. The necessary criteria to apply is gender (male or female), being over the age of consent, Eastern Cooperative Oncology Group performance status 0-2, metastatic stage IV or locally advanced breast cancer not yet treated by therapy involving endocrine treatment and palbociclib OR first line ET & palbociclib for metastatic/localised disease, evaluable/measurable pathology data present in tissue collected within 6 months prior to initiating therapy."
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