Pertuzumab + Trastuzumab + Chemotherapy for Advanced Breast Cancer

Recruiting at 2 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Disqualifiers: Hepatitis B/C, HIV, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 18 weeks for LABC or until progression for MBC

63 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies how well pertuzumab, trastuzumab, and paclitaxel albumin-stabilized nanoparticle formulation work in treating patients with human epidermal growth factor receptor (HER) 2-positive stage II-IV breast cancer. Monoclonal antibodies, such as pertuzumab and trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to kill tumor cells or stop them from growing. Giving pertuzumab and trastuzumab together with paclitaxel albumin-stabilized nanoparticle formulation may be a better way to block tumor growth.

Who Is on the Research Team?

Joanne Mortimer, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with HER2-positive advanced breast cancer who haven't had chemotherapy or trastuzumab for metastatic disease. They should have adequate blood counts, no serious medical conditions, and not be pregnant. Prior adjuvant therapy is allowed if it was over 12 months ago. Participants must agree to use contraception during the study.

Inclusion Criteria

You have not received chemotherapy or trastuzumab for metastatic breast cancer treatment before.

If you have metastatic breast cancer, you can participate if you had chemotherapy and trastuzumab more than 12 months ago.

Your white blood cell count is at least 3.0 billion cells per liter.

Exclusion Criteria

You have active hepatitis B or C.

You have nerve problems worse than mild.

Your heart's pumping ability was less than 50% during previous treatment with trastuzumab.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pertuzumab, trastuzumab, and paclitaxel albumin-stabilized nanoparticle formulation intravenously. Treatment repeats every 21 days for up to 6 courses for LABC or until disease progression for MBC.

18 weeks for LABC or until progression for MBC

Visits on days 1, 8, and 15 of each 21-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 3 months for 4 years, then every 6 months for 1 year.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Paclitaxel Albumin-Stabilized Nanoparticle Formulation
• Pertuzumab
• Trastuzumab

Trial Overview The trial tests how well a combination of pertuzumab, trastuzumab, and paclitaxel albumin-stabilized nanoparticle formulation works in treating stage II-IV breast cancer by blocking tumor growth or killing tumor cells.

How Is the Trial Designed?

Group I: Treatment (pertuzumab, trastuzumab, nab-paclitaxel) Experimental Treatment 4 Interventions

Patients receive pertuzumab IV over 30-60 minutes on day 1, trastuzumab IV over 30-90 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+