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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
No Placebo-Only Group
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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 • NCT0078529179%
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%
Headache
7%
Bone pain
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%
Wound dehiscence
4%
Alkaline phosphatase increased
4%
Dysgeusia
4%
Dyspepsia
4%
Skin disorder
4%
Edema limbs
4%
Serum potassium decreased
4%
Serum sodium decreased
4%
Weight loss
3%
Thrombosis
3%
Rectal hemorrhage
3%
Infection
3%
Serum calcium decreased
3%
Abdominal pain
3%
Urinary tract infection
3%
Lymphocyte count decreased
3%
Pruritus
3%
Creatinine increased
3%
Allergic rhinitis
2%
Laryngoscopy abnormal
2%
Nasal congestion
2%
Dehydration
2%
Skin infection
2%
Urinary incontinence
2%
Sinusitis
2%
Chest pain
2%
Syncope
2%
Catheter related infection
2%
Gastrointestinal disorder
2%
Upper respiratory infection
2%
Neck pain
2%
Hot flashes
2%
Voice alteration
2%
Hand-and-foot syndrome
1%
Pharyngolaryngeal pain
1%
Memory impairment
1%
Sweating
1%
Hemorrhage
1%
Musculoskeletal disorder
1%
Cystitis
1%
Respiratory tract hemorrhage
1%
Device related infection
1%
Decubitus ulcer
1%
Ear, nose and throat examination abnormal
1%
Anorectal infection
1%
Chest wall pain
1%
Mini mental status examination abnormal
1%
Fever
1%
Gingival pain
1%
Osteonecrosis
1%
Irregular menstruation
1%
Fracture
1%
Abdominal distension
1%
Pneumonia
1%
Serum phosphate decreased
1%
Renal failure
1%
Dry mouth
1%
Dysphagia
1%
INR increased
1%
Serum calcium increased
1%
Muscle weakness
1%
Muscle weakness lower limb
1%
Skin hyperpigmentation
1%
Skin ulceration
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%
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)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
3,070 Previous Clinical Trials
1,802,692 Total Patients Enrolled
147 Trials studying Breast Cancer
63,203 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,072 Total Patients Enrolled
943 Trials studying Breast Cancer
1,443,258 Patients Enrolled for Breast Cancer
Funda Meric-BernstamPrincipal InvestigatorM.D. Anderson Cancer Center
7 Previous Clinical Trials
12,750 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your platelet count is at least 100,000 per cubic millimeter.I have not had any cancer except for skin or cervical cancer in the last 5 years.I do not have any severe health issues that could affect my participation in the study.My cancer has spread to distant parts of my body.I have cancer in both breasts.I am mostly able to care for myself and carry out normal activities.My kidney function, measured by creatinine, is normal.I am using effective birth control and will continue for 6 months after my treatment ends.I am using or willing to use effective birth control during the study.My cancer tests positive for HER2 protein or gene changes.I stopped my treatment because my condition got worse.Your liver enzymes (ALT and AST) can be slightly higher than normal, but not more than 1.5 times the upper limit of what's considered normal at the hospital.Your bilirubin levels are within the normal range on laboratory tests.I do not have severe nerve damage in my hands or feet.My surgical tissue was checked for remaining cancer and used for further studies.Your alkaline phosphatase levels can be slightly higher than the normal range at the hospital.You have a white blood cell count of at least 1500 per cubic millimeter.Women who can have babies need to have a negative pregnancy test.My breast cancer is HER2-negative, and I've completed specific chemotherapy but still have significant cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (standard of care)
- Group 2: Group I (ixabepilone)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.