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PD0332991 + Anastrozole for Breast Cancer
Study Summary
This trial is testing a new drug to see if it can help treat early stage 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 2015 Phase 2 trial • 19 Patients • NCT01291017Trial Design
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Who is running the clinical trial?
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- I have had a condition where my lymphocytes grow abnormally.I have a history of cancer.I haven't had cancer in the last 5 years, except for skin cancer.You are taking any experimental medications.Your heart's electrical activity takes too long to reset.I haven't had a heart attack, severe chest pain, heart surgery, stroke, mini-stroke, or a serious blood clot in the last 6 months.I am currently on blood thinners.I can swallow pills without difficulty.I can take care of myself and am up and about more than half of my waking hours.My last blood test shows I am in menopause.I have had treatments like surgery, radiation, or chemotherapy for my cancer before joining this study.I do not have any severe illnesses that could interfere with the study.My cancer is inflammatory.My cancer has spread to other parts of my body.My breast cancer is ER+ and HER2-, aiming for surgery to remove the tumor.I am a woman aged 18 or older.My blood tests show normal organ function and blood cell counts.I am not using, nor do I need, strong medication that affects drug metabolism.My tumor is growing quickly and is resistant to hormone therapy.I am HIV-positive and on antiretroviral therapy.I have been treated with a Cdk4 inhibitor before.I have had a biopsy of my breast cancer or a sentinel lymph node biopsy.You are expected to live for more than 4 months.My tumor has a PIK3CA mutation.It's been over 4 weeks since I finished my last chemotherapy and radiation.You have had allergic reactions to drugs similar to PD 0332991 or other drugs being used in the study.I had surgery on my breast and underarm area to remove cancer.
- Group 1: Arm 2: PIK3CA Mutant Type Cohort
- Group 2: Arm 1: PIK3CA Wild Type Cohort
- Group 3: Arm 3: Endocrine Resistant Cohort
- 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 places are participating in this research project?
"Mayo Clinic - Rochester (Rochester, Minnesota), Washington University School of Medicine (Saint Louis, Missouri), and Mayo Clinic - Scottsdale (Scottsdale, Arizona) are a few of the many places where patients can enroll in this clinical trial."
Are people with this medical condition able to sign up for the clinical trial at this time?
"The clinical trial isn't currently recruiting patients. The original posting was on April 10th, 2013, and the most recent edit was on September 22nd, 2022. However, there are 2624 other trials actively searching for participants right now."
To your knowledge, has anything like this been tried before?
"PD0332991 has been under investigation since the year 2000. The first clinical trial was funded by AstraZeneca and took place in 2000 with a pool of 600 participants. After this initial study, PD0332991 received approval to enter Phase 3 drug trials. As of now, there are 252 active studies involving PD0332991 being conducted across 2046 cities and 68 countries worldwide."
What are some of the potential risks associated with PD0332991?
"As this is a phase 2 trial, there is some data to support the safety of PD0332991; however, as there is not yet any evidence for efficacy, it received a score of 2."
Could you please provide more information on other research projects that have studied PD0332991?
"PD0332991 was first trialled in 2000 at the Centre de Recherche Clinique du CHUS. To date, there have been a total of 268 clinical trials completed. Currently, 252 studies are actively recruiting patients, with many of these based out of Rochester, Minnesota."
What indications has PD0332991 been shown to be effective for?
"PD0332991 is not only used to breast cancer, but also for other conditions like endometrial thinning, stage t2b carcinoma of the prostate, and as a radiation sensitizer."
How many people are being asked to participate in this experiment?
"Unfortunately, this study has already ceased recruiting patients. The listing was first created on April 10th, 2013 and last updated on September 22nd, 2022. However, there are 2372 trials actively recruiting breast cancer patients and 252 studies still looking for participants that match the PD0332991 criteria."
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