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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 cancer has not spread to my organs or bones, but may be in many lymph nodes.
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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
~3780
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
1,072 Previous Clinical Trials
340,383 Total Patients Enrolled
140 Trials studying Breast Cancer
22,548 Patients Enrolled for Breast Cancer
Filipa Lynce, MDPrincipal InvestigatorDana-Farber Cancer Institute
4 Previous Clinical Trials
118 Total Patients Enrolled
2 Trials studying Breast Cancer
73 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the inaugural analysis of its type?

"Presently, 1826 Doxorubicin trials are being hosted in 82 countries and 3702 cities. The inaugural study for this drug was sponsored by Alfacell back in 1997; it involved 300 patients and concluded with a Phase 3 approval stage. Over the past 24 years, 2743 studies have been completed on Doxorubicin's effects."

Answered by AI

How many participants are contributing to this clinical experiment?

"This clinical trial has surpassed its recruitment phase; the initial post was dated August 1st 2013, and it last edited on May 2nd 2022. However, if you are still in search of trials to participate in there currently 2596 studies for breast cancer actively recruiting patients as well 1826 research projects that are seeking participants who will be administered doxorubicin."

Answered by AI

Is this research experiment taking on new participants?

"This medical study is no longer recruiting patients. It was first posted on August 1st 2013 and last updated May 2nd 2022. If you are trying to find other trials, there are 2596 studies for breast cancer and 1826 for Doxorubicin currently enrolling participants."

Answered by AI

What have studies revealed to be the primary clinical application of Doxorubicin?

"Cyclophosphamide is typically administered in conjunction with Doxorubicin, which has been demonstrated to be beneficial for managing the progression of kaposi's sarcoma aids related, leukemia and locally advanced non-small cell lung cancer."

Answered by AI

What progress is hoped to be attained from this trial?

"Over an 18 week period, this trial will evaluate the Percentage of Participants With a Pathologic Complete Response (pCR), as well as Median Overall Survival, Residual Disease Rate by Intrinsic Subtype and Predictive Accuracy Rates between Pre-Treatment and On-Treatment Tumor Biopsy RNA Sequencing Profiles. The pCR is defined as no evidence of invasive carcinoma within both breast tissue and axillary lymph nodes after preoperative treatment; while overall survival measures how long patients live from when they start treatment to death or last known date alive. Furthermore, residual disease rate evaluates cancer proliferation based on intrinsic sub"

Answered by AI

Has Doxorubicin been sanctioned by the FDA?

"Our team at Power rated Doxorubicin's safety as a 2 since this is a Phase 2 trial, which suggests that there are some data points affirming its security but none confirming its efficacy."

Answered by AI

Can you elucidate on the other research studies that have been conducted using Doxorubicin?

"Doxorubicin was initially explored in 1997 by the scientists at Spectrum Health Hospital - Butterworth Campus. Presently, there are 2743 finished trials and 1826 active studies, with Ann Arbor being a major hub of research."

Answered by AI
~2 spots leftby Mar 2025