Bilateral Breast CarcinomaPhase 2NCT00877500
Ixabepilone in Treating Participants With Significant Residual Disease of HER2/Neu Negative Invasive Breast Cancer After Systemic Therapy
A Phase 2 study testing Best Practice and Ixabepilone in people with Bilateral Breast Carcinoma and HER2/Neu Negative, run by M.D. Anderson Cancer Center at 3 sites in United States.
Trial summary
This phase II trial studies how well ixabepilone compared with standard of care works in treating patients with HER2/Neu negative breast cancer that remains after undergoing systemic therapy. Ixabepilone works by blocking cell division which may cause cancer cell death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bilateral Breast Carcinoma, HER2/Neu Negative, Invasive Breast Carcinoma
- What is being tested?
- Best Practice and Ixabepilone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Mar 2009to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologic confirmation of invasive HER2/neu-negative breast cancer (immunohistochemistry [IHC] 0-1+ or fluorescence in situ hybridization [FISH]-negative) that have received complete anthracycline and taxane neoadjuvant systemic therapy and that at the time of surgery are expected to have significant residual disease. Therapy should include at least 4 cycles of an anthracycline-based regimen (adriamycin-cytoxan [AC], 5-fluorouracil/adriamycin/intravenous [IV] cyclophosphamide [FAC], fluorouracil-epirubicin-IV cytoxan [FEC]) and 12 weeks of a taxane-based regimen (weekly paclitaxel, every 3-week docetaxel).
- Patients who did not complete therapy due to disease progression are eligible.
- Patients with bilateral breast cancers are eligible.
- Patients should have a Karnofsky performance scale of >= 70%.
- Peripheral granulocyte count of >= 1500/mm^3.
- Platelet count >= 100000 mm^3.
Show all 17Show fewer
- Bilirubin within normal laboratory values.
- Alkaline phosphatase may be up to 1.5 x upper limit of normal (ULN) of the institution.
- Transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) may be up to 1.5 x upper limit of normal (ULN) of the institution.
- Creatinine levels within normal range.
- Negative serum pregnancy test for a woman of childbearing potential.
- Women of childbearing potential (WOCP) must use a reliable and appropriate contraceptive method during the study and 6 months after chemotherapy is completed. Women of childbearing potential (WOCBP) are women who are not menopausal for 12 months or had no previous surgical sterilization.
- Patients must agree to have study tissue collections and blood sample collections.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.
- Patients should have their surgical tissues evaluated for residual cancer burden (RCB) and be used for correlative studies.
- Sexually active women of childbearing potential must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.
- All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study. In addition, all WOCBP will be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation. The principal investigator (PI) will immediately notify BMS in the event of a confirmed pregnancy in a patient participating in the study.
Who cannot join
- Patients whose tumors express HER2 protein or have HER2/neu gene amplification.
- Patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer.
- 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).
- Patients with a pre-existing peripheral neuropathy > grade 1.
- Evidence of distant metastases.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967
M D Anderson Cancer Center
Houston, Texas, 77030
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
About this study
Official title: A Phase II Randomized Study of Ixabepilone vs. Observation in Patients With Significant Residual Disease After Neoadjuvant Systemic Therapy for HER2/Neu-Negative Breast Cancer
This phase II trial studies how well ixabepilone compared with standard of care works in treating patients with HER2/Neu negative breast cancer that remains after undergoing systemic therapy. Ixabepilone works by blocking cell division which may cause cancer cell death.
Read the detailed description
PRIMARY OBJECTIVES:
- To investigate the genomic (transcriptional profiles) and proteomic (pathway activation) features that distinguish tumors that do not achieve a pathologic complete response (pCR) after neoadjuvant systemic therapy (NST) and correlate these features with outcome in the presence and absence of adjuvant ixabepilone.
II. To evaluate the presence of circulating tumor cells (CTCs) at baseline (before chemotherapy starts; if radiation is used, after radiation ends), during and after ixabepilone therapy or during observation.
SECONDARY OBJECTIVES:
- To collect serial blood samples for future pharmacogenomic studies. II. To determine if the addition of adjuvant ixabepilone will improve recurrence-free survival in patients that have significant residual HER 2/neu-negative breast cancer after NST.
III. To assess the toxicity of adjuvant ixabepilone in this group of patients.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I (IXABEPILONE): Participants receive ixabepilone intravenously (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 (STANDARD OF CARE): Participants receive standard of care for 18 weeks.
After completion of study treatment, participants are followed up every 3 months for 2 years and every 6 months for 3 years.
- Being tested
- Best Practice, Ixabepilone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
IxabepiloneDrug
Also called (1S,3S,7S,10R,11S,12S,16R)-7,11-Dihydroxy-8,8,10,12,16-pentamethyl-3-[(1E)-1-methyl-2-(2-methyl-4-thiazolyl)ethenyl]-17-oxa-4-azabicyclo[14.1.0]heptadecane-5,9-dione, Azaepothilone B, BMS 247550, BMS-247550
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Group I (ixabepilone) | Experimental | 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. Receives: Drug: Ixabepilone |
| Group II (standard of care) | Active comparator | Participants receive standard of care for 18 weeks. Receives: Other: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic (transcriptional profiles) and proteomic (pathway activation) features that distinguish tumors
RPPA will be used to objectively quantify (phospho)protein expression. Functional activation of the pathway will be defined as an increase in phosphorylation of at least one half of the components of each pathway above the median RPPA quantified activation across the entire tumor set. Data will be analyzed for the presence of clusters based on differential protein expression by using available methods with the R statistical software package. A variety of unsupervised clustering methods (including hierarchical clustering, K-means, independent component analysis, mutual information, and gene shaving) will be used to classify the samples into statistically similar groups.
Measured: Up to 5 years
Significant circulating tumor cells (CTCs)
Presence of any cell per 7.5 ml of whole blood.
Measured: At 18 weeks
Secondary outcomes (2)
Incidence of adverse events in each group
Chi-square tests of independence and generalized logistic regression models will be used.
Measured: Up to 5 years
Recurrence-free survival
Will be estimated non-parametrically using the Kaplan-Meier product limit method. Cox proportional hazards regression models will be used to model recurrence-free survival as a function of treatment group.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study start30 Mar 2009
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bilateral Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Funda Meric-Bernstam, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877500
- Sponsor's protocol ID
- 2008-0435
- Other IDs
- NCI-2018-01849, 2008-0435
- Status last verified
- May 2026
- First submitted
- 6 Apr 2009
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Gonzalez-Angulo AM, Lei X, Alvarez RH, Green MC, Murray JL, Valero V, Koenig KB, Ibrahim NK, Litton JK, Nair L, Krishnamurthy S, Hortobagyi GN, Meric-Bernstam F. Phase II Randomized Study of Ixabepilone Versus Observation in Patients With Significant Residual Disease After Neoadjuvant Systemic Therapy for HER2-Negative Breast Cancer. Clin Breast Cancer. 2015 Oct;15(5):325-31. doi: 10.1016/j.clbc.2015.03.004. Epub 2015 Mar 24.
PubMed 25913905
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of Ixabepilone vs. Observation in Patients With Significant Residual Disease After Neoadjuvant Systemic Therapy for HER2/Neu-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT00877500
- Acronym / sponsor ID
- 2008-0435
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Mar 2009 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well ixabepilone compared with standard of care works in treating patients with HER2/Neu negative breast cancer that remains after undergoing systemic therapy. Ixabepilone works by blocking cell division which may cause cancer cell death.
Detailed description
PRIMARY OBJECTIVES:
- To investigate the genomic (transcriptional profiles) and proteomic (pathway activation) features that distinguish tumors that do not achieve a pathologic complete response (pCR) after neoadjuvant systemic therapy (NST) and correlate these features with outcome in the presence and absence of adjuvant ixabepilone.
II. To evaluate the presence of circulating tumor cells (CTCs) at baseline (before chemotherapy starts; if radiation is used, after radiation ends), during and after ixabepilone therapy or during observation.
SECONDARY OBJECTIVES:
- To collect serial blood samples for future pharmacogenomic studies. II. To determine if the addition of adjuvant ixabepilone will improve recurrence-free survival in patients that have significant residual HER 2/neu-negative breast cancer after NST.
III. To assess the toxicity of adjuvant ixabepilone in this group of patients.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I (IXABEPILONE): Participants receive ixabepilone intravenously (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 (STANDARD OF CARE): Participants receive standard of care for 18 weeks.
After completion of study treatment, participants are followed up every 3 months for 2 years and every 6 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (ixabepilone) | Experimental | Drug: IxabepiloneParticipants 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 (standard of care) | Active comparator | Other: Best PracticeParticipants receive standard of care for 18 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients with histologic confirmation of invasive HER2/neu-negative breast cancer (immunohistochemistry [IHC] 0-1+ or fluorescence in situ hybridization [FISH]-negative) that have received complete anthracycline and taxane neoadjuvant systemic therapy and that at the time of surgery are expected to have significant residual disease. Therapy should include at least 4 cycles of an anthracycline-based regimen (adriamycin-cytoxan [AC], 5-fluorouracil/adriamycin/intravenous [IV] cyclophosphamide [FAC], fluorouracil-epirubicin-IV cytoxan [FEC]) and 12 weeks of a taxane-based regimen (weekly paclitaxel, every 3-week docetaxel).
- Patients who did not complete therapy due to disease progression are eligible.
- Patients with bilateral breast cancers are eligible.
- Patients should have a Karnofsky performance scale of >= 70%.
- Peripheral granulocyte count of >= 1500/mm^3.
Key exclusion criteria (5 listed)
- Patients whose tumors express HER2 protein or have HER2/neu gene amplification.
- Patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer.
- 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).
- Patients with a pre-existing peripheral neuropathy > grade 1.
- Evidence of distant metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Group II (standard of care) |
| IxabepiloneAlso: (1S,3S,7S,10R,11S,12S,16R)-7,11-Dihydroxy-8,8,10,12,16-pentamethyl-3-[(1E)-1-methyl-2-(2-methyl-4-thiazolyl)ethenyl]-17-oxa-4-azabicyclo[14.1.0]heptadecane-5,9-dione, Azaepothilone B, BMS 247550, BMS-247550Given IV | Drug | Group I (ixabepilone) |
Primary outcome
Genomic (transcriptional profiles) and proteomic (pathway activation) features that distinguish tumors
Time frame: Up to 5 years
RPPA will be used to objectively quantify (phospho)protein expression. Functional activation of the pathway will be defined as an increase in phosphorylation of at least one half of the components of each pathway above the median RPPA quantified activation across the entire tumor set. Data will be analyzed for the presence of clusters based on differential protein expression by using available methods with the R statistical software package. A variety of unsupervised clustering methods (including hierarchical clustering, K-means, independent component analysis, mutual information, and gene shaving) will be used to classify the samples into statistically similar groups.
Significant circulating tumor cells (CTCs)
Time frame: At 18 weeks
Presence of any cell per 7.5 ml of whole blood.
2 secondary outcomes
Incidence of adverse events in each group
Time frame: Up to 5 years
Recurrence-free survival
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 25913905Gonzalez-Angulo AM, Lei X, Alvarez RH, Green MC, Murray JL, Valero V, Koenig KB, Ibrahim NK, Litton JK, Nair L, Krishnamurthy S, Hortobagyi GN, Meric-Bernstam F. Phase II Randomized Study of Ixabepilone Versus Observation in Patients With Significant Residual Disease After Neoadjuvant Systemic Therapy for HER2-Negative Breast Cancer. Clin Breast Cancer. 2015 Oct;15(5):325-31. doi: 10.1016/j.clbc.2015.03.004. Epub 2015 Mar 24.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Funda Meric-Bernstam principal investigator
M.D. Anderson Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Best Practice and Ixabepilone in people with Bilateral Breast Carcinoma and HER2/Neu Negative, run by M.D. Anderson Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic (transcriptional profiles) and proteomic (pathway activation) features that distinguish tumors (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00877500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.