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Microtubule Inhibitor

Ixabepilone for Breast Cancer

Phase 2
Waitlist Available
Led By Funda Meric-Bernstam
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with bilateral breast cancers are eligible.
Patients should have a Karnofsky performance scale of >= 70%.
Must not have
Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper gastrointestinal [GI] tract ulceration).
Evidence of distant metastases.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial compares ixabepilone to standard of care for treating patients with HER2/Neu negative breast cancer.

Who is the study for?
This trial is for women with HER2/Neu negative invasive breast cancer who still have significant disease after systemic therapy. They must be able to use contraception, have a Karnofsky performance scale of >= 70%, normal creatinine and bilirubin levels, no history of other invasive cancers in the last 5 years (except certain skin/cervical cancers), and no severe pre-existing conditions.
What is being tested?
The trial is testing Ixabepilone's effectiveness compared to standard care in treating patients with residual breast cancer post-therapy. Ixabepilone aims to block cell division, potentially leading to cancer cell death.
What are the potential side effects?
Ixabepilone may cause side effects such as fatigue, nausea, muscle or joint pain, hair loss, neuropathy (nerve problems), low blood counts increasing infection risk, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have cancer in both breasts.
Select...
I am mostly able to care for myself and carry out normal activities.
Select...
My kidney function, measured by creatinine, is normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe health issues that could affect my participation in the study.
Select...
My cancer has spread to distant parts of my body.
Select...
My cancer tests positive for HER2 protein or gene changes.
Select...
I do not have severe nerve damage in my hands or feet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Genomic (transcriptional profiles) and proteomic (pathway activation) features that distinguish tumors
Significant circulating tumor cells (CTCs)
Secondary study objectives
Incidence of adverse events in each group
Recurrence-free survival

Side effects data

From 2017 Phase 3 trial • 799 Patients • NCT00785291
79%
Peripheral sensory neuropathy
76%
Fatigue
47%
Hypertension
43%
Neutrophil count decreased
34%
Myalgia
25%
Epistaxis
21%
Proteinuria
20%
Leukocyte count decreased
18%
Hemoglobin decreased
18%
Nausea
17%
Peripheral motor neuropathy
15%
Arthralgia
13%
Diarrhea
13%
Constipation
13%
Alopecia
12%
Blood glucose increased
12%
Nail disorder
10%
Cough
10%
Dyspnea
9%
Anorexia
8%
Mucositis oral
8%
Pain
8%
Hypersensitivity
8%
Platelet count decreased
7%
Bone pain
7%
Headache
7%
Vomiting
7%
Insomnia
6%
Back pain
6%
Pain in extremity
6%
Rash desquamating
6%
Anxiety
6%
Aspartate aminotransferase increased
5%
Alanine aminotransferase increased
5%
Dizziness
5%
Depression
4%
Serum albumin decreased
4%
Alkaline phosphatase increased
4%
Dyspepsia
4%
Dysgeusia
4%
Skin disorder
4%
Edema limbs
4%
Wound dehiscence
4%
Serum potassium decreased
4%
Serum sodium decreased
4%
Weight loss
3%
Serum calcium decreased
3%
Thrombosis
3%
Rectal hemorrhage
3%
Abdominal pain
3%
Infection
3%
Urinary tract infection
3%
Lymphocyte count decreased
3%
Pruritus
3%
Creatinine increased
3%
Allergic rhinitis
2%
Dehydration
2%
Chest pain
2%
Laryngoscopy abnormal
2%
Nasal congestion
2%
Skin infection
2%
Sinusitis
2%
Urinary incontinence
2%
Catheter related infection
2%
Gastrointestinal disorder
2%
Upper respiratory infection
2%
Neck pain
2%
Syncope
2%
Hot flashes
2%
Voice alteration
2%
Hand-and-foot syndrome
1%
Serum calcium increased
1%
Muscle weakness
1%
Muscle weakness lower limb
1%
INR increased
1%
Anorectal infection
1%
Pneumonia
1%
Osteonecrosis
1%
Decubitus ulcer
1%
Skin ulceration
1%
Mini mental status examination abnormal
1%
Abdominal distension
1%
Fracture
1%
Musculoskeletal disorder
1%
Serum phosphate decreased
1%
Renal failure
1%
Chest wall pain
1%
Memory impairment
1%
Dry mouth
1%
Dysphagia
1%
Ear, nose and throat examination abnormal
1%
Gingival pain
1%
Fever
1%
Device related infection
1%
Cystitis
1%
Irregular menstruation
1%
Pharyngolaryngeal pain
1%
Skin hyperpigmentation
1%
Sweating
1%
Hemorrhage
1%
Depressed level of consciousness
1%
Urogenital disorder
1%
Scalp pain
1%
Arthritis
1%
Vision blurred
1%
Oral pain
1%
Hypoxia
1%
Lymphedema
1%
Sinus tachycardia
1%
Cataract
1%
Eye disorder
1%
Watering eyes
1%
Esophagitis
1%
Chills
1%
Localized edema
1%
Bladder infection
1%
Bronchitis
1%
Kidney infection
1%
Nail infection
1%
Rhinitis infective
1%
Tooth infection
1%
Serum potassium increased
1%
Serum triglycerides increased
1%
Bladder hemorrhage
1%
Hemoglobin urine positive
1%
Hemorrhage urinary tract
1%
Urinary frequency
1%
Pelvic pain
1%
Respiratory disorder
1%
Respiratory tract hemorrhage
1%
Hematoma
1%
Edema
1%
Death NOS
1%
Infectious colitis
1%
Sepsis
1%
Bone marrow hypocellular
1%
Anal hemorrhage
1%
Hemorrhoidal hemorrhage
1%
Hemorrhoids
1%
Agitation
1%
Confusion
1%
Serum cholesterol increased
1%
Weight gain
1%
Vaginal hemorrhage
1%
Dry skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (Paclitaxel)
Arm B (Nab-paclitaxel)
Arm C (Ixabepilone)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (ixabepilone)Experimental Treatment1 Intervention
Participants receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Group II: Group II (standard of care)Active Control1 Intervention
Participants receive standard of care for 18 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixabepilone
2006
Completed Phase 3
~2270

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,585 Total Patients Enrolled
148 Trials studying Breast Cancer
63,277 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,884 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 Patients Enrolled for Breast Cancer
Funda Meric-BernstamPrincipal InvestigatorM.D. Anderson Cancer Center
7 Previous Clinical Trials
12,750 Total Patients Enrolled

Media Library

Ixabepilone (Microtubule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00877500 — Phase 2
Breast Cancer Research Study Groups: Group II (standard of care), Group I (ixabepilone)
Breast Cancer Clinical Trial 2023: Ixabepilone Highlights & Side Effects. Trial Name: NCT00877500 — Phase 2
Ixabepilone (Microtubule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00877500 — Phase 2
~2 spots leftby Dec 2024
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