Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen bySenthilkumar Damodaran

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase Ib/II trial studies the side effects and best dose of copanlisib when given together with trastuzumab and pertuzumab and to see how well they work after induction treatment in treating patients with HER2 positive stage IV breast cancer with PIK3CA or PTEN mutation. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Trastuzumab is a form of "targeted therapy" because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Monoclonal antibodies, such as pertuzumab, may kill tumor cells that are left after chemotherapy. The addition of copanlisib to the usual treatment (trastuzumab and pertuzumab) could shrink the cancer or stabilize it for longer duration as compared to the usual treatment alone.

Research Team

Senthilkumar Damodaran

Principal Investigator

University of Texas MD Anderson Cancer Center LAO

Eligibility Criteria

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

Phase 1B: Any prior number of lines of therapy in metastatic setting is allowed, provided patients are considered candidates for trastuzumab and pertuzumab combination or on maintenance trastuzumab and pertuzumab (with or without prior chemotherapy) as long as dose limiting toxicity (DLT) can be determined

For Phase 2: Patients should have only received first line of induction chemotherapy (taxane) with trastuzumab and pertuzumab in the metastatic setting

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Exclusion Criteria

Immunosuppressive therapy is not allowed while on study

Human immunodeficiency virus (HIV)-positive patients, unless they have CD4 counts > 500 cells/mm^3 in the past 6 months and do not require CYP3A4-interactive antiretroviral therapy

Active infection requiring IV antibiotics or other uncontrolled intercurrent illness requiring hospitalization

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Treatment Details

Interventions

Copanlisib (PI3K inhibitor)
Pertuzumab (Monoclonal Antibodies)
Trastuzumab (Monoclonal Antibodies)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Phase I, Phase II Arm I (copanlisib, trastuzumab, pertuzumab)Experimental Treatment3 Interventions

Patients receive copanlisib IV over 60 minutes on days 1 and 8. Patients also receive trastuzumab IV over 30-90 minutes and pertuzumab IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Phase II Arm II (trastuzumab, pertuzumab)Active Control2 Interventions

Patients receive trastuzumab IV over 30-90 minutes and pertuzumab IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.