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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Response to Paclitaxel

Secondary study objectives

Antimitotic Effects

Change in CIN Levels

Correlate Drug Levels With Aneuploidy of Tumor

+6 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

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

Musculoskeletal pain

Aspartate aminotransferase increased

Headache

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met