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Anastrozole + Palbociclib for Breast Cancer
Study Summary
This trial is testing whether a combination of two drugs is safe and effective for treating breast cancer in postmenopausal women.
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 do not have active brain metastases or related conditions.You are allergic to anastrozole.I am not taking any strong medications that affect liver enzymes.I haven't had major surgery or cancer treatment in the last 3 weeks.I am HIV positive.I have had a bone marrow or stem cell transplant.I am 18 years old or older.I can take care of myself and am up and about more than half of my waking hours.I do not have any severe health or mental conditions that could make this study risky for me.My cancer can be measured by scans or is only in my bones.I have not received treatment for metastatic disease in Cohort A.I stopped my first chemotherapy 21 days ago and it worked. I may have had chemo before for early cancer treatment.I am postmenopausal or can receive hormone therapy if not.My most recent tumor biopsy shows that my cancer is ER or PR positive.My latest tumor biopsy shows I do not have HER2-positive cancer.My breast cancer is advanced and cannot be removed with surgery.I can provide samples of my tumor, either from previous or new biopsies.I have been treated with a CDK inhibitor before.I haven't had heart, brain, or lung problems in the last 6 months.I have had hormone therapy for my cancer before surgery or as an additional treatment.My stomach or intestines do not work well, affecting how I absorb medication.My organs and bone marrow are functioning normally.
- Group 1: Cohort A: First-line therapy
- Group 2: Cohort B: Maintenance therapy
- 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
Has Palbociclib been tested in prior medical studies?
"As of now, 191 trials using Palbociclib are currently running worldwide. Of these studies 36 have entered the final phase 3 stage. The majority of clinical sites utilizing this treatment can be found in Burgas, New jersey; however, a total of 13528 trial locations exist around the globe."
What is the principal application of Palbociclib?
"Palbociclib can be applied to manage breast cancer, as well as other malignant neoplasms with hormone receptor unknown and in cases where 2-3 years of tamoxifen therapy have failed."
What is the current enrollment cap for this medical research?
"Unfortunately, this trial has already stopped taking applications. First posted in October 2016 and last revised on June 2022, it is now closed to new enrolment. However, there are still 2282 studies actively recruiting for breast cancer and 191 trials looking for participants that can take Palbociclib."
Is enrollment still open for this clinical research?
"This clinical trial is not currently recruiting patients. It was posted on October 26, 2016 and last updated June 23, 2022. If you are interested in alternative studies, there are 2282 active breast cancer trials and 191 Palbociclib-related investigations searching for participants."
Do the potential benefits of Palbociclib outweigh any possible risks?
"Although there have been some examinations into palbociclib's safety, efficacy data is still absent. Thus, our team at Power gave it a rating of 2 on the 1-3 scale."
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