A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to Sequential AC Followed by Paclitaxel in Women with Early Stage Breast Cancer Revised Protocol 02 incorporating Protocol Amendments 02 (version 1.0, dated 25-May-07) and 03 (version 1.0, dated 22-May-08) + Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 1.0, dated 21-Dec-2006).

Phase 1

• Conditions: BREAST CANCER; MedDRA version: 9.1 Level: LLT Classification code 10006190 Term: Breast cancer invasive NOS

• Registration Number: EUCTR2006-003047-24-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-18
• Study Completion: 2009-12-14
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 330

Inclusion Criteria

1/ Signed Written Informed Consent

2/ Target Population
a) Histologically confirmed primary invasive adenocarcinoma of the breast T2-3, N0-3, M0, with tumor size = 2.0 cm..
b) All patients with early stage breast adenocarcinoma may enroll irrespective of receptor status.
c) No prior treatment (irradiation, chemotherapy, hormonal, immunotherapy or investigational, etc.) for breast cancer excluding therapy for DCIS. Subjects receiving hormone replacement therapy (HRT) are eligible if this therapy is discontinued at least 2 weeks before starting study therapy.
d) Subjects who received hormonal therapy (e.g. tamoxifen) or radiotherapy for DCIS may enroll.
e) Disease free of prior malignancy for >= 5 years with the exception of curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
f) Karnofsky performance status (KPS) of 80 - 100.
g) Accessible for treatment and follow-up.
h) Baseline MUGA or echocardiogram scan with LVEF of >= 50%.
i) Adequate recovery from recent surgery. At least 4 weeks from major surgery. No recovery period is required for minor surgery.

3/ Laboratory Parameters
a) Absolute neutrophil count (ANC) >= 1500/mm³
b) Total bilirubin =< 1.5 times the upper limit of normal (ULN).
c) AST or ALT =< 2.5 times the upper limit of normal (ULN).
d) Platelets >= 100,000/ mm3.
e) Serum creatinine = 1.5 x ULN or creatinine clearance > 60 mL/min (measured or
calculated by Cockcroft-Gault method).
f) Normal PTT and either INR or PT < 1.5 x ULN.

4/ Women, at least 18 years of age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1/ Sex and Reproductive Status
a) WOCBP who are unwilling or unable to use an acceptable method to avoid
pregnancy for the entire study period and for up to 8 weeks after the last dose of
investigational drug.
b) Women who are pregnant (including positive pregnancy test at enrollment or
prior to study drug administration) or breastfeeding.

2/ Target Disease Exceptions
a) Evidence of metastatic breast cancer following a standard tumor staging work-up.
b) Evidence of inflammatory breast cancer.
c) Evidence of baseline sensory or motor neuropathy.

3/ Medical History and Concurrent Diseases
a) Known human immunodeficiency viral (HIV) infection.
b) Serious intercurrent infections or non-malignant medical illnesses that are
uncontrolled or the control of which may be jeopardized by this therapy.
c) Psychiatric disorders or other conditions rendering the subject incapable of
complying with the requirements of the protocol.
d) Clinically significant history of cardiovascular disease (history of unstable angina,
congestive heart failure, uncontrolled hypertension, myocardial infarction or
valvular heart disease).
e) Subjects unfit for breast and/or axillary surgery (complete fixation of tumor, skin
infiltration, erythema of the breast, and/or ulceration).
f) Current participation in another drug trial.
g) Subjects who received prior anthracycline therapy.

4/ Known allergy to any of the study drugs or to agents containing Cremophor® EL.

5/ Prohibited Therapies and/or Medications
a) Other concurrent anti-tumor, chemotherapy, hormonal therapy, immunotherapy
regimens or radiation therapy, standard or investigational.
b) The following medication must be discontinued 72 hours prior to initiation of AC
therapy and be withheld during AC therapy: barbiturates, phenytoin, chloral
hydrate, corticosteroids, succinylcholine, allopurinol, imipramine and
phenothiazines. Short term use of corticosteroids (as antiemetics or as HSR
prophylaxis) will be allowed. (See Section 5.5.1, for other prohibited medications
prior to and during administration of ixabepilone or paclitaxel).
6/ Prisoners or subjects who are compulsorily detained

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified