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Paclitaxel for Breast Cancer
Phase 4
Recruiting
Led By Mark Burkard
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women with pathologically demonstrated breast cancer
Patients must be candidates for neoadjuvant paclitaxel chemotherapy by their treating oncologist. No other investigational or commercial therapeutic agents may be given concurrently with the paclitaxel.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will test whether paclitaxel can kill tumors that have pre-existing chromosomal instability.
Who is the study for?
This trial is for women with breast cancer who are eligible for neoadjuvant paclitaxel chemotherapy. They must not have metastatic disease, should not have received prior systemic chemotherapy for their current breast cancer, and must be able to undergo biopsies and imaging tests.
What is being tested?
The study is testing if weekly treatments of Paclitaxel before surgery can help treat breast cancer by increasing chromosomal instability in tumors. The treatment spans over four cycles of three weeks each, with infusions on days 1, 8, and 15.
What are the potential side effects?
Paclitaxel may cause side effects such as allergic reactions, changes in blood counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or pain, muscle aches, nausea, vomiting and hair loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with breast cancer through a biopsy.
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My doctor has approved me for a specific chemotherapy before surgery, without other experimental treatments.
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My cancer has not spread to other parts of my body according to recent tests.
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I can provide at least 8 slides or a tumor block from a previous biopsy.
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My tumor or affected lymph node can be easily biopsied.
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I am willing to have another biopsy of my breast tumor or lymph node.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Response to Paclitaxel
Secondary study objectives
Antimitotic Effects
Change in CIN Levels
Correlate Drug Levels With Aneuploidy of Tumor
+6 moreSide effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Alanine aminotransferase increased
13%
Neurotoxicity
13%
Cough
13%
Vomting
9%
Musculoskeletal pain
9%
Headache
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Weekly PaclitaxelExperimental Treatment1 Intervention
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5450
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,047 Total Patients Enrolled
943 Trials studying Breast Cancer
1,443,132 Patients Enrolled for Breast Cancer
University of Wisconsin, MadisonLead Sponsor
1,237 Previous Clinical Trials
3,200,929 Total Patients Enrolled
36 Trials studying Breast Cancer
38,481 Patients Enrolled for Breast Cancer
Mark BurkardPrincipal InvestigatorUniversity of Wisconsin, Madison