Paclitaxel for Breast Cancer

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Breast CancerPaclitaxel - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to week 12

Up to week 12
Maximum concentration (Cmax) of paclitaxel plasma
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

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Trastuzumab
59%Leukopenia
56%Neutropenia
34%Hypoaesthesia
31%Agranulocytosis
22%Alopecia
22%Asthenia
19%Pyrexia
16%Nail disorder
16%Hypophagia
16%Oedema peripheral
16%Diarrhoea
13%Cough
13%Vomting
13%Alanine aminotransferase increased
13%Neurotoxicity
9%Headache
9%Rash
9%Chest discomfort
9%Anaemia
9%Nausea
9%Bone marrow failure
9%Aspartate aminotransferase increased
9%Musculoskeletal pain
9%Pigmentation disorder
6%Insomnia
6%Transaminases increased
6%Paronychia
6%Flushing
6%Thrombocytopenia
6%Face oedema
6%Nasopharyngitis
6%Mouth ulceration
6%Constipation
3%Completed suicide
3%Cataract
3%Infection
3%Upper respiratory tract infection
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01301729) in the Trastuzumab ARM group. Side effects include: Leukopenia with 59%, Neutropenia with 56%, Hypoaesthesia with 34%, Agranulocytosis with 31%, Alopecia with 22%.

Trial Design

2 Treatment Groups

Normal SMA (>7310 mm^2)
1 of 2
Low SMA (5120 - 7310 mm^2) and Sarcopenic SMA (<5120 mm^2)
1 of 2

Active Control

Experimental Treatment

22 Total Participants · 2 Treatment Groups

Primary Treatment: Paclitaxel · No Placebo Group · Phase 4

Low SMA (5120 - 7310 mm^2) and Sarcopenic SMA (<5120 mm^2)
Drug
Experimental Group · 1 Intervention: Paclitaxel · Intervention Types: Drug
Normal SMA (>7310 mm^2)
Drug
ActiveComparator Group · 1 Intervention: Paclitaxel · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~6440

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 12

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
268 Previous Clinical Trials
18,106 Total Patients Enrolled
28 Trials studying Breast Cancer
3,827 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

Eligibility Criteria

Age 18+ · Female Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to understand the nature and purpose of the study and are willing to sign a written informed consent.
Evaluable computed tomography (CT) scan, e.g.
You have adequate organ function based on paclitaxel label.