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Anti-microtubule agent

Paclitaxel + Trastuzumab + Pertuzumab for Inflammatory Breast Cancer

Phase 2

Waitlist Available

Led By Filipa Lynce, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of inflammatory breast cancer

Willingness to undergo a research biopsy of the affected breast

Must not have

Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest

Uncontrolled intercurrent illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 63 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of an investigational drug to see if it works in treating a specific cancer. The drug, pertuzumab, is being studied in combination with paclitaxel and trastuzumab as a preoperative treatment for inflammatory breast cancer.

Who is the study for?

This trial is for individuals with inflammatory breast cancer that's HER2 positive and haven't had prior breast cancer treatment. Participants must be willing to undergo a biopsy, not have metastatic cancer in organs or bones (though nodal involvement is okay), and can't be pregnant, breastfeeding, or have certain other cancers unless they've been disease-free for 5 years.

What is being tested?

The study tests the combination of paclitaxel, trastuzumab, and pertuzumab as preoperative therapy for inflammatory breast cancer. Pertuzumab is investigational in this context. The goal is to see if this combo reduces the chance of recurrence and helps patients proceed to mastectomy.

What are the potential side effects?

Potential side effects include allergic reactions similar to those from compounds related to the drugs used (paclitaxel, trastuzumab, pertuzumab), issues from biopsies like pain or infection at the site, plus common chemotherapy side effects such as nausea, fatigue, hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with inflammatory breast cancer.

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I am willing to have a biopsy of my affected breast for research.

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My breast cancer is HER2 positive.

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My breast cancer diagnosis was confirmed through a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have trouble breathing even when I'm resting due to lung disease or cancer.

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I do not have any unmanaged ongoing illnesses.

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I have cancer that has spread to my brain.

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I am allergic to certain cancer drugs like paclitaxel or trastuzumab.

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I am HIV positive and on combination anti-retroviral therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 63 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~63 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 63 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentages of Participants With Pathologic Complete Response

Residual Cancer Burden Rate

Secondary study objectives

Median Disease Free Survival

Median Overall Survival

Median Time to Treatment Failure

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment7 Interventions

Run in: Trastuzumab IV 4 mg/kg, Pertuzumab IV 840 mg (Day 1 Week 1) Pre-Op: Trastuzumab IV 2 mg/kg weekly, Paclitaxel 80 mg/m2 IV weekly (beginning on Day 8 Week 2) x 16 doses. Starting Day 21 (week 4) continue trastuzumab and paclitaxel as above, add Pertuzumab 420 mg IV x 3 weeks. After completing 16 doses of Paclitaxel, Trastuzumab (6 mg/kg IV) and Pertuzumab 420 mg IV may be continued x 3 weeks until surgery Modified Radical Mastectomy Post-Op: Option 1: Adriamycin 60 mg/m2 IV and Cyclophosphamide 600 mg/m2 IV x 2-3 weeks x 4 cycles. Followed by Trastuzumab 8 mg/kg and Pertuzumab 840 IV load; followed by Trastuzumab 6 mg/kg every and Pertuzumab 420 mg IV every 3 weeks to complete 12 months of HER2-directed therapy Option 2: Continue Trastuzumab 6 mg/kg and Pertuzumab 420 mg x 3 weeks to complete 12 months of HER2-directed therapy Post-mastectomy radiation to the chest wall / regional lymph nodes and endocrine therapy by standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab

2014

Completed Phase 4

~5190

Pertuzumab

2014

Completed Phase 3

~7500