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GDC-9545 + Palbociclib/LHRH Agonist for Breast Cancer
Study Summary
This trial will study the safety and effectiveness of the drug GDC-9545 as a treatment for people with a certain type of 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?
Media Library
- I have not had major surgery in the last 4 weeks.I have not had radiation therapy in the last 2 weeks.You have a history of significant heart rhythm problems or a past heart attack.I haven't had any cancer other than early-stage uterine, skin (non-melanoma), or cervical (in situ) in the last 3 years.I am HIV positive.I have an active inflammatory bowel condition or have had major GI surgery.I cannot or will not take pills or capsules.I have cancer that can be measured or seen in my bones.My breast cancer has returned or spread and cannot be removed or cured with surgery or radiation.My breast cancer is HER2-negative.I have brain metastases that are either untreated, causing symptoms, or need treatment for symptoms.I am currently taking warfarin or phenytoin.My doctor can safely take samples of my cancer before and during treatment.I am fully active or can carry out light work.All side effects from my previous treatments have mostly gone away.My organs are working well.I am not on any cancer treatments for advanced disease, except if I'm in Cohort X receiving GDC-0810 or GDC-0927.My heart's electrical activity, measured twice, shows a specific irregularity.My advanced cancer does not respond to or cannot tolerate standard treatments.I have had 2 or fewer treatments for advanced breast cancer.It's been over 2 months since I last used tamoxifen and over 6 months since I last used fulvestrant.I have gone through menopause.I am currently taking medication that can affect my heart's rhythm.I have a history or risk of irregular heartbeats due to heart conditions or family history.My tumor is estrogen receptor positive.You are expected to live for at least 12 more weeks.It has been over 2 weeks since my last cancer treatment.I have not been treated with CDK4/6 inhibitors before.I have a serious liver condition, such as hepatitis or cirrhosis.My breast cancer is ER-positive/HER2-negative and has worsened despite hormone therapy.
Frequently Asked Questions
How many geographical areas is this research taking place in?
"Currently, 6 medical facilities are running this clinical trial; these sites can be found in New york, Aurora and Nashville as well as other cities. To reduce the amount of travelling needed to take part in the study, it is best to pick a location close by."
Are there any other research endeavors that have incorporated GDC-9545 into their protocols?
"Currently, 16 trials are in Phase 3 and 133 research initiatives concerning GDC-9545 remain underway. The majority of the studies for GDC-9545 center around Burgas, New jersey, though there is a total of 6577 sites running related clinical experiments."
What has GDC-9545 been indicated to ameliorate?
"GDC-9545 is an efficient treatment for breast cancer and other neoplasms, postmenopausal symptoms, as well as advanced directives."
Has GDC-9545 gained regulatory clearance from the US Food and Drug Administration?
"The safety score for GDC-9545 is estimated to be 1 as per the evaluation conducted by our Power team. This assessment takes into consideration that this clinical trial is in its initial phase, with limited data available on both efficacy and security."
What is the current number of participants in this research project?
"At this juncture, this clinical trial is not enrolling any new patients. The investigation was first posted on 27 November 2017 and the most recent update to the entry happened 28 October 2022. If you are in search of other trials, there are currently 2600 studies for breast cancer recruitment and 133 seeking participants for GDC-9545."
Is the research team looking for participants at this time?
"This particular clinical trial is currently not recruiting participants. Initially posted on November 27th 2017, the latest update to this study was recorded on October 28th 2022. For those exploring other studies, 2600 trials are actively seeking patients with breast cancer and 133 studies for GDC-9545 are accepting new enrollees at present."
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