63 Participants Needed

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
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

JM

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.
See 18 more

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.
See 9 more

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?
1Treatment groups
Experimental Treatment
Group I: Treatment (pertuzumab, trastuzumab, nab-paclitaxel)Experimental Treatment4 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.

Find a Clinic Near You

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+
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