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Palbociclib + Hormone Therapy for Breast Cancer
Study Summary
This trial is studying the side effects and effectiveness of two drugs, palbociclib and letrozole or fulvestrant, in treating older patients with 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.Side effects data
From 2023 Phase 2 trial • 55 Patients • NCT03007979Trial Design
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Who is running the clinical trial?
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- I have no active cancer other than non-melanoma skin cancer or cervical carcinoma in situ, or I have been free of any other cancer for 3 years.Your body has enough infection-fighting white blood cells.My breast cancer is estrogen or progesterone positive and HER2 negative.I have recovered from side effects of previous treatments, except for hair loss.My cancer can be measured by tests or seen on scans.Your liver enzymes (AST and ALT) are not too high, unless you have cancer that has spread to your liver.Your alkaline phosphatase levels are not too high, unless you have bone or liver metastases.I have treated brain metastases and am not currently on steroids.I do not have any infections that need antibiotics.I can swallow and keep down pills.My kidneys are functioning well enough for treatment.I have never been treated with a CDK inhibitor.I do not have interstitial lung disease.I can care for myself and am up and about more than 50% of my waking hours.I am starting palbociclib for my metastatic disease and may have had one prior treatment.Your platelet count is at least 100,000 per mm^3.I can read and understand English or Spanish.Your bilirubin level in your blood is within a certain range, unless you have a specific condition called Gilbert's disease.
- Group 1: Treatment (palbociclib, letrozole or fulvestrant)
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 objectives are being targeted via this clinical trial?
"The primary endpoint of this research trial, which will span up to one year, is the incidence of adverse effects. Secondary aims include evaluating progression-free survival (PFS) using Kaplan-Meier methodology, quantifying patients' quality of life with the European Quality of Life Five Dimension Three Level Questionnaire (EQ-5D-3L), and estimating overall survival times with Kaplan Meier methodology."
How many venues are managing this investigation?
"This research effort is currently recruiting from a grand total of 100 sites, some of which are based in Delaware, Hibbing and Westerville. For the convenience of potential participants, it's advised to select the trial centre closest to them so they can avoid lengthy journeys during the study."
Have any prior experiments studied the effects of Palbociclib?
"Currently, a total of 334 clinical trials are running for Palbociclib. Of those studies, 68 have reached the third phase of trialling and 18656 sites across Shanghai offer treatments with this drug."
How many individuals are being enrolled in this medical trial?
"Unfortunately, this clinical trial is currently closed to new participants. It was initially listed on August 15th 2018 and last updated September 17th 2021. If you are looking for similar studies, 2288 trials searching for patients with HER2/neu negative status and 334 Palbociclib trails are actively seeking volunteers."
Is this investigation currently recruiting participants?
"This trial is no longer recruiting participants. It began on August 15th 2018 and was most recently edited September 17th 2021. However, if you are searching for other studies, there are 2288 trials actively looking to recruit patients with her2/neu negative issues, as well as 334 trials that involve Palbociclib medications which have openings for enrolment."
For which ailments is Palbociclib typically prescribed?
"Palbociclib has been demonstrated to effectively treat progression, disease, tamoxifen and postmenopausal symptoms."
Does the FDA allow Palbociclib to be utilized in clinical practice?
"Though not yet proven efficacious, Palbociclib has been evaluated as having some level of safety and was thus assigned a score of 2."
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