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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%.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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I am mostly able to care for myself and carry out normal activities.
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My kidney function, measured by creatinine, is normal.
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I am using effective birth control and will continue for 6 months after my treatment ends.
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I am using or willing to use effective birth control during the study.
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I stopped my treatment because my condition got worse.
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My surgical tissue was checked for remaining cancer and used for further studies.
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My breast cancer is HER2-negative, and I've completed specific chemotherapy but still have significant cancer.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Genomic (transcriptional profiles) and proteomic (pathway activation) features that distinguish tumors
Significant circulating tumor cells (CTCs)
Secondary outcome measures
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%
Alkaline phosphatase increased
4%
Serum albumin decreased
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%
Rectal hemorrhage
3%
Thrombosis
3%
Abdominal pain
3%
Infection
3%
Urinary tract infection
3%
Lymphocyte count decreased
3%
Pruritus
3%
Creatinine increased
3%
Allergic rhinitis
2%
Skin infection
2%
Chest pain
2%
Dehydration
2%
Laryngoscopy abnormal
2%
Sinusitis
2%
Urinary incontinence
2%
Catheter related infection
2%
Gastrointestinal disorder
2%
Upper respiratory infection
2%
Neck pain
2%
Syncope
2%
Nasal congestion
2%
Hot flashes
2%
Voice alteration
2%
Hand-and-foot syndrome
1%
Musculoskeletal disorder
1%
Renal failure
1%
Anorectal infection
1%
Serum calcium increased
1%
Abdominal distension
1%
Pneumonia
1%
Fracture
1%
INR increased
1%
Chest wall pain
1%
Muscle weakness
1%
Osteonecrosis
1%
Mini mental status examination abnormal
1%
Memory impairment
1%
Muscle weakness lower limb
1%
Skin ulceration
1%
Decubitus ulcer
1%
Serum phosphate decreased
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
2,958 Previous Clinical Trials
1,798,153 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,608 Previous Clinical Trials
40,915,217 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
Funda Meric-BernstamPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
12,702 Total Patients Enrolled

Media Library

Ixabepilone (Microtubule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00877500 — Phase 2
Breast Cancer Research Study Groups: Group I (ixabepilone), Group II (standard of care)
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

Frequently Asked Questions

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

Has Ixabepilone been granted authorization from the FDA?

"This drug has been tested in clinical trials, which gives it a safety rating of 2. Though there is limited data on its efficacy, the testing conducted thus far indicates that Ixabepilone is relatively safe to use."

Answered by AI

Does this research endeavor still have open enrollment for participants?

"At the moment, no further recruitment is occurring for this clinical trial which was initially posted on March 30th 2009. If you are searching for alternative studies to join, 4558 trials related to carcinoma and 5 research programmes involving ixabepilone currently have open slots."

Answered by AI

What further investigations have been performed on Ixabepilone?

"Currently, there are 5 studies for Ixabepilone in progress with none of them being at the final phase. Although Baltimore is the primary hub for these trials, you can find research centres across 260 different locations that have undertaken this investigation."

Answered by AI

What is the upper limit of participants in this clinical experiment?

"This clinical trial has concluded its search for participants. It was posted on March 30th 2009 and the last update occurred September 22nd 2022. If you are looking to join another medical study, currently there are 4558 trials accepting applicants with carcinoma diagnosis and 5 studies recruiting individuals taking Ixabepilone medication."

Answered by AI
~6 spots leftby Dec 2024