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Combination Therapy for Breast Cancer
Study Summary
This trial is testing if any of these combinations can help treat 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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- You have had a serious allergic reaction to the study drug or any of its ingredients in the past.I am not taking any medications that affect my heart's rhythm.You have a current hepatitis B or hepatitis C virus infection.I had cancer before, but it's been 3 years and it was not likely to come back, or it was a minor skin, breast, or cervical cancer treated within the last 5 years.I have not received a live vaccine within the last 4 weeks.I have an autoimmune disease but it's not severe and doesn't require immunosuppressive treatment.I am not pregnant and will not breastfeed if I join the study.Your liver enzymes should be within a certain range, unless you have cancer that has spread to your liver.I am HIV positive or have AIDS and may need antiretroviral therapy.I have a history of immune conditions like colitis or lung issues needing steroids.Your total bilirubin level should be below a certain limit, unless you have documented Gilbert's disease.I am using reliable birth control methods to prevent pregnancy.I haven't had cancer treatment in the last 14 days and have recovered from previous treatment side effects.I am allergic to palbociclib or similar medications.I am not on strong immune-suppressing drugs, except for low-dose steroids or certain topical forms.My cancer is spreading quickly and could soon lead to life-threatening issues.I stopped taking palbociclib due to side effects or needed to lower the dose more than once.I am a man or a woman (pre- or postmenopausal) and if premenopausal, I have been on a GNRH agonist for 4 weeks.My breast cancer is hormone receptor positive and HER2 negative, and cannot be surgically removed.I have been on hormone and CDK4/6 therapy for my cancer for at least 6 months without it getting worse.I am 18 years old or older.I do not have any serious ongoing illnesses that my doctor thinks could interfere with the study.I have been treated with CDK4/6 inhibitors and hormone therapy for my cancer.I have had at most one chemotherapy treatment for my cancer after it spread.I have had 1-2 prior hormone treatments for my cancer, but not fulvestrant.I had radiotherapy for comfort care over 2 weeks ago and have mild or no side effects.My kidney function, measured by creatinine levels, is normal or nearly normal.I agree to use birth control during and for 60 days after the study if there's a risk of pregnancy.I can swallow and keep down pills.My cancer progressed after treatment with endocrine therapy and CDK 4/6 inhibitors.I can carry out all my usual activities without help.I have brain metastases but they are stable and I don't need steroids for symptoms.Your heart's electrical activity (QTc) is less than 480 milliseconds when measured before starting the study.My organ and bone marrow functions are normal.Your white blood cell count is too low.I have had an organ or stem-cell transplant.I am not taking any strong medication that affects liver enzymes.Your hemoglobin level is higher than 9 grams per deciliter.I am premenopausal and have a negative pregnancy test.You have a platelet count higher than 100,000 per microliter.
- Group 1: Fulvestrant
- Group 2: Fulvestrant with Palbociclib
- Group 3: Fulvestrant with Palbociclib and Avelumab
- 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 conditions are commonly addressed through the use of Palbociclib?
"Palbociclib is used to manage progression of illness, ameliorate disease symptoms, implement advance directives, and treat postmenopausal issues."
Is this clinical trial currently enrolling participants?
"Looking at clinicaltrials.gov, the data suggests that this trial is not presently accepting patients. Having been initially published on August 9th 2017 and last changed on September 19th 2022, it appears as though there are currently no openings for this study; however, 2639 other medical trials are actively enrolling individuals."
Are there any Canadian healthcare facilities administering this trial?
"The University of Kansas Cancer Center - Lee's Summit in Lee's Summit, Missouri, Indiana University in Indianapolis, Indiana and Vanderbilt University Medical Center in Nashville, Tennessee are the primary medical facilities hosting this clinical trial. Additionally 22 other sites have been identified to assist with enrolment."
Could you please provide information on previous trials that have incorporated Palbociclib?
"The first clinical trial of palbociclib was held at Lowell General Hospital in 2004 and has since been studied 201 times. Presently, 342 trials are actively being conducted, with the majority taking place near Lee's Summit, Missouri."
Has Palbociclib been granted regulatory acceptance by the Food and Drug Administration?
"Palbociclib has been assigned a risk score of 2 due to its status as a Phase 2 trial. This rating denotes that there is some evidence pointing towards the drug's safety, but no data supporting efficacy yet."
What is the estimated sample size for this research endeavor?
"This medical trial is currently not accepting participants. It was initially published on August 9, 2017 and most recently revised on September 19, 2022. For those who are interested in other studies, there are presently 2297 clinical trials actively recruiting for malignant neoplasms and 342 trials involving Palbociclib that require volunteers."
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