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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 63 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentages of Participants With Pathologic Complete Response
Residual Cancer Burden Rate
Secondary outcome measures
Median Disease Free Survival
Median Overall Survival
Median Time to Treatment Failure
+5 more

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
Paclitaxel
2011
Completed Phase 4
~5380
Doxorubicin
2012
Completed Phase 3
~7940
Cyclophosphamide
1995
Completed Phase 3
~3770
Mastectomy
2017
N/A
~11160
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
340,907 Total Patients Enrolled
141 Trials studying Breast Cancer
22,597 Patients Enrolled for Breast Cancer
Filipa Lynce, MDPrincipal InvestigatorDana-Farber Cancer Institute
5 Previous Clinical Trials
196 Total Patients Enrolled
3 Trials studying Breast Cancer
151 Patients Enrolled for Breast Cancer
Beth Overmoyer, MDPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
43 Total Patients Enrolled
2 Trials studying Breast Cancer
23 Patients Enrolled for Breast Cancer

Media Library

Paclitaxel (Anti-microtubule agent) Clinical Trial Eligibility Overview. Trial Name: NCT01796197 — Phase 2
Breast Cancer Research Study Groups: Treatment Arm
Breast Cancer Clinical Trial 2023: Paclitaxel Highlights & Side Effects. Trial Name: NCT01796197 — Phase 2
Paclitaxel (Anti-microtubule agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01796197 — Phase 2
~2 spots leftby May 2025
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