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.
Eligible Conditions
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 8 Secondary · Reporting Duration: 63 months
Year 1
Number of Participants With Congestive Heart Failure
18 Weeks
Pathological Complete Response Rate by Intrinsic Subtype
Predictive Accuracy Rate of Pre-Treatment Versus On-Treatment Tumor Biopsy RNA Sequencing Profiles
Residual Cancer Burden Rate
Morbidity - disease rate
18 weeks
Percentages of Participants With Pathologic Complete Response
Residual Cancer Burden Rate by ctDNA Profile Change
63 months
Median Disease Free Survival
Median Overall Survival
Median Time to Treatment Failure
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
1 Treatment Group
Treatment Arm
1 of 1
Experimental Treatment
23 Total Participants · 1 Treatment Group
Primary Treatment: Doxorubicin · No Placebo Group · Phase 2
Treatment ArmExperimental Group · 7 Interventions: Mastectomy, Cyclophosphamide, Radiation Therapy, Doxorubicin, Pertuzumab, Trastuzumab, Paclitaxel · Intervention Types: Procedure, Drug, Radiation, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mastectomy
2017
N/A
~10140
Cyclophosphamide
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7010
Doxorubicin
FDA approved
Pertuzumab
FDA approved
Trastuzumab
FDA approved
Paclitaxel
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 63 months
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,016 Previous Clinical Trials
393,775 Total Patients Enrolled
134 Trials studying Breast Cancer
21,645 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
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have HER2 positive breast cancer.
A diagnosis of non-metastatic cancer must be made
References
- Pernas, Sonia, Jennifer L. Guerriero, Sergey Naumenko, Shom Goel, Meredith M. Regan, Jiani Hu, Beth T. Harrison, et al.. 2022. “Early On-treatment Transcriptional Profiling as a Tool for Improving Pathological Response Prediction in Her2-positive Inflammatory Breast Cancer”. Therapeutic Advances in Medical Oncology. SAGE Publications. doi:10.1177/17588359221113269.
- Filipa Lynce, MD 2013. "Paclitaxel + Trastuzumab + Pertuzumab as Pre-Op for Inflammatory BrCa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01796197.
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Conditions
Cancer Related
Treatments