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Paclitaxel for Breast Cancer

Phase 4
Recruiting
Led By Daniel L Hertz, PharmD, PhD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage 1-3 breast cancer
Adequate organ function based on paclitaxel label
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 12
Awards & highlights

Study Summary

This trial is testing whether lengthening the infusion time for paclitaxel normalizes levels of the drug in patients with low muscle mass.

Who is the study for?
This trial is for individuals with Stage 1-3 breast cancer who are planning or undergoing neoadjuvant, adjuvant, or curative intent chemotherapy with paclitaxel. Participants must have adequate organ function and an evaluable CT scan from the past year. Pregnant or nursing individuals, those with hypersensitivity to paclitaxel components, or those on certain CYP2C8 inhibitors/inducers cannot join.Check my eligibility
What is being tested?
The study tests if extending the infusion time of paclitaxel in patients with low skeletal muscle area can normalize drug concentration levels compared to those with normal muscle area receiving a standard infusion duration.See study design
What are the potential side effects?
Paclitaxel may cause side effects like allergic reactions (to its components), blood disorders, nerve damage (neuropathy), muscle and joint pain, nausea, vomiting, diarrhea, hair loss (alopecia), and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer is at stage 1, 2, or 3.
Select...
My organs are working well enough for chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum concentration (Cmax) of paclitaxel plasma
Secondary outcome measures
One-hour Cmax in normal SMA patients vs. one-hour Cmax in low SMA patients
Two- to three-hour Cmax vs. one-hour Cmax in low SMA patients

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%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Aspartate aminotransferase increased
9%
Musculoskeletal pain
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Insomnia
6%
Transaminases increased
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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Low SMA (5120 - 7310 mm^2) and Sarcopenic SMA (<5120 mm^2)Experimental Treatment1 Intervention
Adjusted paclitaxel infusion time during only one dose; standard paclitaxel infusion time for all other doses.
Group II: Normal SMA (>7310 mm^2)Active Control1 Intervention
Standard paclitaxel infusion time.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
292 Previous Clinical Trials
24,043 Total Patients Enrolled
32 Trials studying Breast Cancer
3,966 Patients Enrolled for Breast Cancer
Daniel L Hertz, PharmD, PhDPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Breast Cancer
60 Patients Enrolled for Breast Cancer

Media Library

Paclitaxel Clinical Trial Eligibility Overview. Trial Name: NCT05183126 — Phase 4
Breast Cancer Research Study Groups: Normal SMA (>7310 mm^2), Low SMA (5120 - 7310 mm^2) and Sarcopenic SMA (<5120 mm^2)
Breast Cancer Clinical Trial 2023: Paclitaxel Highlights & Side Effects. Trial Name: NCT05183126 — Phase 4
Paclitaxel 2023 Treatment Timeline for Medical Study. Trial Name: NCT05183126 — Phase 4

Frequently Asked Questions

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

Has the regulatory agency sanctioned Paclitaxel?

"Paclitaxel has been approved, so it scored a 3 on our safety scale."

Answered by AI

What is the current enrollment size of this research trial?

"Affirmative. Information posted on clinicaltrials.gov declares that recruitment for this medical trial is still ongoing, having first been announced on March 28th 2022 and updated most recently on July 18th 2022. This study requires the enrolment of 22 volunteers from a single site."

Answered by AI

Is there any availability for participation in this research initiative?

"According to data found on clinicaltrials.gov, this trial is currently seeking volunteers. The initial listing was posted on March 28th 2022 and the details were recently updated on July 18th of the same year."

Answered by AI
~1 spots leftby May 2024