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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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


The Study Drug:

Ixabepilone is designed to work by blocking cell division, which may cause cancer cell
death.

Surgery:

You will have surgery as part of your standard of care. Your tissue will be tested to
measure residual disease (leftover cancer). If there is a low amount of leftover disease,
you will not be eligible to take part in this study.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to 1 of 2 groups.

If you are in Group 1, you will receive ixabepilone. You also will be treated with the
standard of care treatments for the disease, including radiation and/or hormonal therapy (if
appropriate).

If you are in Group 2, you will not receive the study drug. You will be treated with the
standard of care treatments for the disease, including radiation and/or hormonal therapy (if
appropriate).

Study Drug Administration for Group 1:

If you are in Group 1, you will receive ixabepilone though a needle in your vein over 3
hours on Day 1 of each 21-day study cycle.

Before the infusion, you will be given drugs, by vein, to help decrease the risk of an
allergic reaction. These drugs will include Benadryl® (diphenhydramine), Tagamet®
(cimetidine), and Decadron (dexamethasone). The infusion will last 30-45 minutes.

If you experience severe side effects, future treatments may be delayed, the dose may be
decreased, or you may be taken off study.

Study Visits:

Group 1:

On Day 1 of each cycle, the following tests and procedures will be performed:

- Your medical history will be recorded.

- Your performance status will be recorded.

- Blood (about 2 teaspoons) will be drawn for routine tests.

- You will have a physical exam.

- You will be asked about any side effects you may be experiencing or may have
experienced since the last visit.

Group 2:

At the end of radiation (or on the day of your baseline blood collection), and at Weeks 9
and 18, you will have a physical exam and your medical history will be recorded.

Circulating Tumor Cell (CTC) testing:

Blood (about 2 tablespoons each time) will be drawn before surgery to measure the amount of
CTCs in your blood. If you are in Group 1, blood will be drawn again at Cycles 4 and at the
end of Cycle 6. If you are in Group 2, blood will be drawn again at Weeks 9 and 18.

Length of Study:

If you are in Group 1, you may receive the study drug for up to 6 cycles. You will be taken
off study early if the disease gets worse or intolerable side effects occur.

If you are in Group 2, you will be off study after Week 18.

This is an investigational study. Ixabepilone is FDA approved and commercially available
for metastatic (advanced) breast cancer.

Up to 116 patients will take part in this multicenter study. Up to 116 may be enrolled at
MD Anderson.


Inclusion Criteria:



1. Patients with histologic confirmation of invasive HER2/neu-negative breast cancer
(IHC 0-1+ or 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 (AC, FAC, FEC) and 12 weeks of a taxane-based regimen
(weekly paclitaxel, every 3-week docetaxel).

2. Patients who did not complete therapy due to disease progression are eligible.

3. Age >/= 18 years

4. Patients with bilateral breast cancers are eligible.

5. Patients should have a Karnofsky performance scale of =/> 70%.

6. Patient should have adequate bone marrow function, as defined by peripheral
granulocyte count of >/= 1500/mm^3, and platelet count >/= 100000 mm^3.

7. Patients must have adequate liver function with a bilirubin within normal laboratory
values. Alkaline phosphatase and transaminases (ALT and AST) may be up to 1.5 x upper
limit of normal (ULN) of the institution.

8. Patients should have adequate renal function with creatinine levels within normal
range.

9. Negative serum pregnancy test for a woman of childbearing potential.

10. Women of childbearing potential (WOCP) must use a reliable and appropriate
contraceptive method during the study and 6 months after chemotherapy is completed.
WOCBP are women who are not menopausal for 12 months or had no previous surgical
sterilization.

11. Patients must agree to have study tissue collections and blood sample collections.

12. Patients must sign an informed consent indicating that they are aware of the
investigational nature of the study, in keeping with institutional policy.

13. Patients should have their surgical tissues evaluated for RCB and be used for
correlative studies.

14. Sexually active women of childbearing potential must use an effective method of birth
control during the course fo 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.

15. 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 PI will immediately notify BMS in the event of a confirmed
pregnancy in a patient participating in the study.

Exclusion Criteria:

1. Patients whose tumors express HER2 protein or have HER2/neu gene amplification.

2. 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

3. 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 GI tract ulceration)

4. Patients with a pre-existing peripheral neuropathy > grade 1.

5. Evidence of distant metastases.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Genomic (transcriptional profiles) + Proteomic (pathway activation) Tumor Features

Outcome Time Frame:

Blood tests Day 1 of each 21-day cycle (up to 6 cycles)

Safety Issue:

Yes

Principal Investigator

Ana Gonzalez-Angulo, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0435

NCT ID:

NCT00877500

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • HER2/neu-negative Breast Cancer
  • Residual Breast Cancer
  • Surgery
  • Neoadjuvant Systemic Therapy
  • NST
  • Ixabepilone
  • BMS-247550
  • Epothilone B analogue
  • Breast Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030