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H3B-6545 + Palbociclib for Breast Cancer
Study Summary
This trial is testing a combination of two drugs to treat estrogen receptor-positive breast cancer. The goal is to find the maximum tolerated dose and/or the recommended Phase 2 dose of the combination.
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.Trial Design
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Who is running the clinical trial?
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- You are currently using alcohol or drugs in a harmful way.My bone marrow and organs are working well.I have received treatment for cancer after it spread.I cannot take pills by mouth or have a problem absorbing food.I am fully active or restricted in physically strenuous activity but can do light work.I do not have any serious ongoing infections.I haven't had major surgery or local treatments in the last 4 weeks.My breast cancer is ER+ and HER2-, and it has spread or come back.I have heart problems or a history of heart issues.
- Group 1: Palbociclib + H3B-6545 (Dose Escalation and Dose Expansion)
- 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
Are there numerous health care facilities conducting this experiment?
"Currently, there are 5 clinical trial sites recruiting participants for this research study. These locations span from Kansas City to Nashville and Sarasota. To reduce travel needs, please consider selecting the closest clinic available."
How many individuals is the research team recruiting for this trial?
"This investigation is no longer recruiting participants. It was first advertised on April 1st 2020, and the latest update to its status occurred on November 2nd 2022. If you are in search of other trials, there are currently 2287 clinical experiments actively enrolling patients related to estrogen receptors and 133 studies for Palbociclib (in 75 mg, 100 mg, or 125mg doses) that require volunteers."
Are there still openings for participants in this experiment?
"Unfortunately, this particular study is not accepting applications at the moment. It was initially posted on April 1st 2020 and last edited November 2nd 2022. Although, there are many other clinical trials seeking candidates with receptors, estrogen and Palbociclib (75, 100 or 125 milligrams) that have open enrollment: a total of 2287 studies for the former and 133 trials for the latter."
Is there any additional research into the efficacy of Palbociclib in doses of 75, 100 and 125mg?
"Palbociclib (75, 100, 125 milligram [mg]) first underwent testing at Unimed Medical Institute in 2012. Since its inception there have been 75 completed trials with an additional 133 medical studies actively recruiting participants. Much of this research is conducted from Kansas City, Missouri."
What pathologies is Palbociclib (75, 100, 125 milligram [mg]) prescribed to manage?
"Palbociclib (75mg, 100mg, 125mg) is employed to treat and manage breast cancer as well as malignant neoplasms, postmenopause-associated conditions, and advance directives."
Could you please elaborate on the potential threats associated with Palbociclib dosing (75, 100, 125 milligram [mg])?
"Our analysts rate the safety of Palbociclib (75, 100 and 125 milligrams) as a 1 due to its classification in Phase I clinical trials. This indicates that it has limited evidence for efficacy or safety."
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