Copanlisib + Eribulin for Triple Negative Breast Cancer

Not currently recruiting at 48 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best way to use two drugs, copanlisib and eribulin, to treat advanced triple negative breast cancer that has metastasized. The researchers are examining the effectiveness of these drugs in combination and their potential side effects. Copanlisib (copanlisib hydrochloride) blocks enzymes that promote cancer cell growth, while eribulin (eribulin mesylate) is a chemotherapy drug that prevents cancer cells from dividing and spreading. Suitable candidates for this trial include those with metastatic triple negative breast cancer who have undergone other treatments and can provide a tumor sample for research. As a Phase 1, Phase 2 trial, this study focuses on understanding the treatment's effects in people and assessing its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but certain medications are not allowed. You cannot take strong inhibitors or inducers of CYP3A4, some herbal medications, or high-dose systemic corticosteroids while participating in the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of copanlisib and eribulin has been studied for safety in treating advanced triple-negative breast cancer. Patients in previous studies generally tolerated the combination well. Common side effects include tiredness and nausea, which can be managed. Serious side effects are less common but may include high blood sugar and infections.

The FDA has already approved eribulin for other cancers, indicating its well-known safety profile, although it might act differently when combined with copanlisib. The trial aims to find the optimal dose that balances efficacy with safety for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Copanlisib and Eribulin for triple negative breast cancer because it offers a different approach compared to current treatments like chemotherapy. Most standard treatments attack rapidly dividing cells, but Copanlisib works by inhibiting a specific enzyme called PI3K, which plays a role in cancer cell growth and survival. Additionally, combining Copanlisib with Eribulin, an existing chemotherapy drug, could enhance its effectiveness by targeting cancer cells in a new way. This innovative combination has the potential to improve outcomes for patients with triple negative breast cancer, a challenging type of cancer to treat.

What evidence suggests that this trial's treatments could be effective for triple negative breast cancer?

Research has shown that combining copanlisib with eribulin may help treat advanced triple-negative breast cancer. In this trial, participants in certain arms will receive this combination. Studies suggest that copanlisib enhances eribulin's effectiveness by inhibiting enzymes that promote cancer cell growth. Lab models have tested this combination, demonstrating stronger effects against tumors compared to eribulin alone. These early findings indicate that this drug pair could offer a more effective option for combating this aggressive cancer. ^{1 2 3 4 6}

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 I, DL2 (eribulin, copanlisib) Experimental Treatment 6 Interventions

Phase I, DL2: Patients receive copanlisib (45 mg) IV over 1 hour and eribulin (1.4 mg/m\^2) 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, DL1 (eribulin, copanlisib) Experimental Treatment 6 Interventions

Phase I, DL1: Patients receive copanlisib (45 mg) IV over 1 hour and eribulin (1.1 mg/m\^2) 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: Group II (Phase II, DL1, eribulin, copanlisib) Experimental Treatment 6 Interventions

Group II (Phase II, DL1): Patients receive copanlisib (45 mg) IV over 1 hour and eribulin (1.1 mg/m\^2) 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 IV: Group I (Phase II, eribulin) Active Control 5 Interventions

Group I (Phase II): Patients receive eribulin (1.4 mg/m\^2) 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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04345913

NCT04345913 | Testing the Addition of Copanlisib to ... Giving copanlisib and eribulin together may work better in treating advanced stage triple negative breast cancer compared to eribulin alone. Detailed ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11152037/

Evaluation of Copanlisib in Combination with Eribulin in Triple ... PI3K inhibition enhances the anti-tumor effect of eribulin in triple negative breast cancer. Oncotarget 2019;10:3667–80. [PMC free article] ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-02319

Testing the Addition of Copanlisib to Eribulin in Metastatic ... Giving copanlisib and eribulin together may work better in treating advanced stage triple negative breast cancer compared to eribulin alone. Eligibility ...

4. asco.org asco.org/abstracts-presentations/ABSTRACT372734

A phase I/II trial evaluating the safety and efficacy of ... A phase I/II trial evaluating the safety and efficacy of eribulin in combination with copanlisib in patients with metastatic triple-negative breast cancer (TNBC) ...

5. digitalcommons.wustl.edu digitalcommons.wustl.edu/oa_4/3851/

"Evaluation of copanlisib in combination with eribulin ... Evaluation of copanlisib in combination with eribulin in triple-negative breast cancer patient-derived xenograft models.

6. withpower.com withpower.com/trial/phase-2-breast-neoplasms-7-2020-b180f

Copanlisib + Eribulin for Triple Negative Breast Cancer 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 ...