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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

Must not have

Concomitant use of strong inhibitors of CYP3A4 and strong inducers of CYP3A4 is not permitted

Other medications that are prohibited while on copanlisib treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking strong CYP3A4 inhibitors or inducers.

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I am not taking any medications that are not allowed with copanlisib treatment.

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I do not have any unmanaged ongoing illnesses.

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I have not had a platelet transfusion in the week before starting treatment.

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My heart's electrical activity is normal, with no prolonged QT interval or risk of Torsades de Pointes.

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I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.

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I have moderate to severe nerve damage.

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My blood pressure is not controlled by medication.

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I have previously been treated with eribulin.

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I have a wound, ulcer, or bone fracture that is not healing.

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I do not have a serious infection worse than grade 2.

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I am not on immunosuppressive therapy.

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I have been treated with nitrosoureas or mitomycin C before.

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I have not had chemotherapy or radiotherapy in the last 3 weeks.

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I have been treated with a PI3K/mTOR/AKT pathway inhibitor before.

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I am allergic to certain cancer drugs similar to those used in this study.

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I have a long QT syndrome from birth.

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My tumor has an AKT mutation.

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I have had Pneumocystis pneumonia in the past.

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I have been diagnosed with pheochromocytoma.

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My kidney tests show high levels of protein in my urine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD) (Phase I)

Progression free survival (PFS) (Phase II)

Recommended phase 2 dose (RP2D) (Phase I)

Secondary study objectives

CBR (Phase II)

Clinical benefit rate (CBR) (Phase I)

ORR (Phase II)

+4 more

Other study objectives

Intrinsic and adaptive resistance mechanisms

PTEN IHC results

Tumor tissue mutation or gene expression profiles

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Biopsy

2014

Completed Phase 4

~1150

Biospecimen Collection

2004

Completed Phase 3

~2030