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PI3K Inhibitor
Copanlisib + Eribulin for Triple Negative Breast Cancer
Phase 1 & 2
Waitlist Available
Led By Nusayba Bagegni
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who have progressed on at least one and not more than five prior chemotherapy regimens, including in the neoadjuvant, adjuvant, and metastatic settings
Patients with history of known type I or type II diabetes must have a fasting glucose level of < 120 mg/dL on at least 2 separate occasions or glycosylated hemoglobin measurement (HbA1c) < 8.5% at screening within 14 days prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of copanlisib given with eribulin for treating patients with advanced stage triple negative breast cancer.
Who is the study for?
This trial is for adults with advanced-stage triple negative breast cancer who have undergone no more than five prior chemotherapy treatments. They must not be pregnant or breastfeeding, agree to use contraception if applicable, and cannot have certain heart conditions or uncontrolled illnesses. Participants need normal blood counts and organ function tests, and those with treated brain metastases showing no progression are eligible.Check my eligibility
What is being tested?
The trial is testing the combination of copanlisib hydrochloride (which blocks enzymes needed for cell growth) with eribulin mesylate (a chemotherapy drug that kills or stops cancer cells from growing). The study aims to determine the best dose of copanlisib and its effectiveness when combined with eribulin compared to using eribulin alone in treating advanced triple negative breast cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to blocking enzymes necessary for cell growth which could affect various organs, as well as typical chemotherapy-related side effects such as fatigue, nausea, low blood counts leading to increased infection risk, hair loss except alopecia may persist. Specific side effects from copanlisib might also occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had 1 to 5 chemotherapy treatments for my cancer.
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I have diabetes with controlled blood sugar levels.
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My hepatitis B virus is undetectable with treatment.
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My cancer's PIK3CA and PTEN mutation status is known from previous tests.
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I am mostly active and can care for myself.
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I am 18 years old or older.
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I had hepatitis C but have been treated and cured.
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My breast cancer is triple-negative.
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My kidney function tests are within normal limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) (Phase I)
Progression free survival (PFS) (Phase II)
Recommended phase 2 dose (RP2D) (Phase I)
Secondary outcome measures
CBR (Phase II)
Clinical benefit rate (CBR) (Phase I)
ORR (Phase II)
+4 moreOther outcome measures
Circulating biomarkers predictive of treatment response
Intrinsic and adaptive resistance mechanisms
PTEN IHC results
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (eribulin, copanlisib)Experimental Treatment6 Interventions
Patients receive copanlisib IV over 1 hour and eribulin IV over 2 to 5 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI at screening, cycle 3 day 1, and every 9 weeks thereafter. Patients also undergo a biopsy at baseline, cycle 2 day 1, and at time of disease progression and blood sample collection at baseline, cycle 2 day 1, every 9 weeks and at time of disease progression.
Group II: Group I (eribulin)Active Control5 Interventions
Patients receive eribulin IV over 2 to 5 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI at screening, cycle 3 day 1, and every 9 weeks thereafter. Patients also undergo a biopsy at baseline, cycle 2 day 1, and at time of disease progression and blood sample collection at baseline, cycle 2 day 1, every 9 weeks and at time of disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biopsy
2014
Completed Phase 4
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Eribulin Mesylate
2014
Completed Phase 4
~3420
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,047 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Nusayba BagegniPrincipal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your white blood cell count is at least 3,000 per microliter.I am not taking strong CYP3A4 inhibitors or inducers.I am not taking any medications that are not allowed with copanlisib treatment.I have previously been treated with anthracycline and taxane.I am HIV positive, on stable ART, and have an undetectable viral load.I do not have any unmanaged ongoing illnesses.I have not had a platelet transfusion in the week before starting treatment.My heart's electrical activity is normal, with no prolonged QT interval or risk of Torsades de Pointes.I have had 1 to 5 chemotherapy treatments for my cancer.I have diabetes with controlled blood sugar levels.My hepatitis B virus is undetectable with treatment.I have a history of heart issues or have been treated with heart-toxic drugs.Your lipase level is not more than 1.5 times the upper limit of normal.Your liver enzymes (AST and ALT) are not more than three times the normal level.I am on a stable dose of blood thinners like warfarin or heparin.Your hemoglobin level is at least 8.0 grams per deciliter.I agree to use birth control if I can become pregnant.I can take medication to prevent nausea as usual.I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.I have moderate to severe nerve damage.My brain cancer has not worsened after treatment.My blood pressure is not controlled by medication.I have another cancer, but it won't affect this trial's treatment.My cancer's PIK3CA and PTEN mutation status is known from previous tests.Your platelet count is at least 100,000 per microliter.I have previously been treated with eribulin.I am mostly active and can care for myself.I have a wound, ulcer, or bone fracture that is not healing.I do not have a serious infection worse than grade 2.You have a history of or currently have an autoimmune disease.I am not on immunosuppressive therapy.I am 18 years old or older.Your international normalized ratio (INR) blood test result is not more than 1.5 times the upper limit of normal.I have been treated with nitrosoureas or mitomycin C before.I have not had chemotherapy or radiotherapy in the last 3 weeks.I have been treated with a PI3K/mTOR/AKT pathway inhibitor before.You are currently taking any other experimental medications.I am allergic to certain cancer drugs similar to those used in this study.I have a long QT syndrome from birth.I agree to provide samples of my tumor for research and to a biopsy if needed.I had hepatitis C but have been treated and cured.I have not taken any myeloid growth factors in the week before starting treatment.I have recovered from side effects of previous cancer treatments, except for hair loss.My tumor has an AKT mutation.I have had Pneumocystis pneumonia in the past.Your partial thromboplastin time (PTT) test result is within a certain range.You have a sufficient number of a type of white blood cell called neutrophils.Your total bilirubin levels must be within a certain range, unless you have Gilbert syndrome, in which case a higher range is allowed.My breast cancer is triple-negative.I have had a blood clot in the last 3 months.I have been diagnosed with pheochromocytoma.My kidney function tests are within normal limits.My kidney tests show high levels of protein in my urine.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (eribulin, copanlisib)
- Group 2: Group I (eribulin)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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