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Hormone Therapy
Liquid Biopsy-Informed Therapy for Breast Cancer
Phase 2
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All reversible prior toxicity related to prior therapies must have recovered to grade ≤ 1 (consult CCTG in the case of irreversible toxicity) and have adequate washout as follows (screening may occur during the washout period): Longest of the following (for questions or any proposed variance, please discuss with CCTG prior to patient enrollment): Two weeks; 5 half-lives for investigational agents; standard cycle length of standard therapies
Patients must have histologically and/or cytologically confirmed, advanced / metastatic breast cancer, ER ≥10% and not HER2 overexpressing/amplified as per ASCO/CAP criteria. Patients with locally advanced or inflammatory disease without distant metastases that is potentially resectable or treatable with curative intent are not eligible
Must not have
Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to protocol.
angina pectoris, symptomatic pericarditis, coronary artery bypass grafting, coronary angioplasty, or stenting, or myocardial infarction in the previous 12 months;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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.
Who is the study for?
This trial is for adults with ER+/HER2- metastatic breast cancer that has worsened after CDK4/6 inhibitor therapy. Participants must have a life expectancy of at least 3 months, be able to receive treatment and follow-up at the center, and not have had certain treatments or conditions that could interfere with the study.
What is being tested?
The trial tests if liquid biopsies can predict which patients will benefit from specific treatments like RP-6306, Gemcitabine, Niraparib, Fulvestrant or just observation. It involves screening blood/tissue for biomarkers before starting any substudy treatment.
What are the potential side effects?
Potential side effects depend on the specific drugs given but may include nausea, fatigue, low blood counts increasing infection risk, liver function changes and potential allergic reactions to drug components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My side effects from previous treatments have mostly gone away.
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My breast cancer is advanced or metastatic, ER positive, and not HER2 overexpressing.
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I am 18 years old or older.
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My kidney function tests are within normal limits.
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My liver enzyme levels are not more than 5 times the upper limit if I have liver cancer spread.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have a tissue sample from my cancer and agreed to its use for research.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any serious infections or illnesses that would interfere with the treatment.
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I have not had heart issues like angina, heart surgery, or a heart attack in the last year.
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I have a history of severe heart failure or cardiomyopathy.
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My heart's pumping ability is normal or above.
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I do not have an active infection needing treatment or known HIV, hepatitis B, or C.
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I have had a bone marrow or double umbilical cord blood transplant.
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My blood pressure is not well-managed according to Canadian standards.
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I have had pneumonitis that needed treatment with steroids.
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My breast cancer is HER2 positive according to the latest tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
3Treatment groups
Experimental Treatment
Group I: Substudy C - Niraparib + FulvestrantExperimental Treatment2 Interventions
Group II: Substudy B - RP-6306 + GemcitabineExperimental Treatment2 Interventions
RP-6306 80mg BID D1-3, D8-10 and D15-17. Gemcitibine D1 and D8
Group III: Substudy A - MonitoringExperimental Treatment1 Intervention
Monitoring substudy. Biomarker+ (6=23); Biomarker- (n=6-23).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3890
Gemcitabine
2017
Completed Phase 3
~1920
Niraparib
2018
Completed Phase 4
~2400
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
127 Previous Clinical Trials
67,790 Total Patients Enrolled
8 Trials studying Breast Cancer
8,240 Patients Enrolled for Breast Cancer
Philippe BedardStudy ChairUHN - Princess Margaret Cancer Centre
3 Previous Clinical Trials
76 Total Patients Enrolled
1 Trials studying Breast Cancer
37 Patients Enrolled for Breast Cancer
Arif Ali AwanStudy ChairOttawa Hospital Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Substudy A - Monitoring
- Group 2: Substudy B - RP-6306 + Gemcitabine
- Group 3: Substudy C - Niraparib + Fulvestrant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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