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Liquid Biopsy-Informed Therapy for Breast Cancer
Study Summary
This trial is testing if looking for biomarkers in breast cancer blood/tissue samples can help predict which treatments will work best. Pre-study screening tests needed.
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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- My side effects from previous treatments have mostly gone away.It's been over 28 days since my last major surgery and my wounds have healed.You have a known condition that weakens your immune system.I do not have any serious infections or illnesses that would interfere with the treatment.I had radiation therapy but it ended at least 4 weeks ago.I have not received a live vaccine within the last 30 days, except for non-live COVID-19 vaccines.I've been treated with CDK4/6 inhibitors for my advanced cancer and it has progressed.I am not on any other cancer treatments except for stable bone-targeted therapy.I am currently on LHRH agonists and did not start them within the last 12 weeks.I have had cancer before, but it was either skin cancer treated well, cervical cancer treated fully in place, or any cancer treated over 2 years ago with no current signs of disease and no ongoing treatment.I do not have any recent serious heart problems.I have not had heart issues like angina, heart surgery, or a heart attack in the last year.My breast cancer is advanced or metastatic, ER positive, and not HER2 overexpressing.I may have had early cancer treatments, but no chemotherapy or ADC for palliative care.My disease is confirmed by tests and scans within the last 21-28 days.I have a history of severe heart failure or cardiomyopathy.I haven't had a blood transfusion or received colony stimulating factors in the last 4 weeks.I can swallow pills and don't have major GI issues affecting drug absorption.I am aware I should be careful using blood thinners like warfarin or aspirin due to my treatment.My heart's pumping ability is normal or above.I do not have an active infection needing treatment or known HIV, hepatitis B, or C.I am using a highly effective method of birth control.I have had a bone marrow or double umbilical cord blood transplant.My blood pressure is not well-managed according to Canadian standards.Your bilirubin levels in your blood are not higher than 1.5 times the upper limit of normal.Your hemoglobin level is at least 90 grams per liter.Your white blood cell count is at least 1.5 x 10^9/L.My cancer progressed after or during my first CDK4/6 inhibitor treatment.I have had certain treatments before.I am 18 years old or older.My kidney function tests are within normal limits.I may have had other treatments or trials that need CCTG review for eligibility.You have a history of not following your doctor's instructions for taking medication.My liver enzyme levels are not more than 5 times the upper limit if I have liver cancer spread.I am fully active or restricted in physically strenuous activity but can do light work.You need to have a certain amount of platelets in your blood.I've had one hormone therapy for my cancer, possibly with a targeted drug like alpelisib.I had brain or spinal cancer but am stable now and haven't taken steroids for a week.I have had pneumonitis that needed treatment with steroids.My breast cancer is HER2 positive according to the latest tests.I have a tissue sample from my cancer and agreed to its use for research.Your AST and ALT levels in the blood are not more than 2.5 times the upper limit of normal.
- Group 1: Substudy A - Monitoring
- Group 2: Substudy B - RP-6306 + Gemcitabine
- Group 3: Substudy C - Niraparib + Fulvestrant
- 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 is the safety profile of Substudy C - Niraparib + Fulvestrant for patients?
"Our team at Power rated Substudy C - Niraparib + Fulvestrant's safety a 2 as it is currently in Phase 2, thus only offering evidence towards the drug's security and not its efficacy."
Is this research experiment currently open to new participants?
"According to the clinicaltrials.gov database, this research study is actively recruiting participants after being initially posted on January 27th 2023 and subsequently updated on February 6th of that same year."
What is the current magnitude of participants in this trial?
"Affirmative. Clinicaltrials.gov confirms that, as of February 6th 2023, this trial is actively recruiting patients; the first posting was made on January 27th 2023 and 484 individuals must be recruited at one site in particular."
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