Copanlisib + Eribulin for Triple Negative Breast Cancer

Recruiting at 43 trial locations

Overseen By Shane R. Stecklein

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers

Disqualifiers: Chemotherapy, Radiotherapy, Neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 25

Duration: Up to 36 months

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I/II trial studies the side effects and best dose of copanlisib and how well it works when given together with eribulin in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as eribulin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving copanlisib and eribulin together may work better in treating advanced stage triple negative breast cancer compared to eribulin alone.

Who Is on the Research Team?

Nusayba Bagegni, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your white blood cell count is at least 3,000 per microliter.

I have previously been treated with anthracycline and taxane.

I am HIV positive, on stable ART, and have an undetectable viral load.

Exclusion Criteria

I am not taking strong CYP3A4 inhibitors or inducers.

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

I do not have any unmanaged ongoing illnesses.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Patients receive eribulin and copanlisib intravenously on days 1 and 8 of each 21-day cycle

Up to 36 months

Every 21 days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 36 months

Every 3 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Copanlisib Hydrochloride
• Eribulin Mesylate

Trial Overview 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.

How Is the Trial Designed?

Group I: Phase II, Group II (copanlisib, eribulin) Experimental Treatment 6 Interventions

Patients receive copanlisib IV over 1 hour and eribulin (lower dose) 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. Additionally, patients 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 as well as blood sample collection at baseline, cycle 2 day 1, every 9 weeks and at time of disease progression.

Group II: Phase I Dose Escalation (copanlisib, eribulin) Experimental Treatment 6 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. Additionally, patients 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 as well as blood sample collection at baseline, cycle 2 day 1, every 9 weeks and at time of disease progression.

Group III: Phase II, Group I (eribulin) Active Control 5 Interventions

Patients receive eribulin (higher dose) 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. Additionally, patients 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 as well as blood sample collection at baseline, cycle 2 day 1, every 9 weeks and at time of disease progression.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+