Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer

Lead Sponsor:

SCRI Development Innovations, LLC

Collaborating Sponsors:

Bristol-Myers Squibb

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

Brief Summary

This is a randomized, Phase III, open-label, multicenter study.

Detailed Description

Patients will be randomized in a 1:1 ratio to receive one of two different treatment arms. Patients in treatment arm 1 will receive AC followed by ixabepilone. Patients in treatment arm 2 will receive...

Eligibility Criteria

Inclusion

  • Female patients greater than or equal to18 years of age.
  • Histologically confirmed invasive unilateral breast cancer (regardless of
  • histology).
  • Early-stage breast cancer, defined as:
  • Node-positive disease: \>0.2-mm metastasis in at least one lymph node (pN1mipN2b)OR
  • Node-negative, with primary tumor \>1.0 cm (T1c-T3).
  • Definitive loco-regional surgery must have been completed as specified
  • below:
  • Patients must have undergone either breast conservation surgery
  • (i.e., lumpectomy) or total mastectomy.
  • Surgical margins of the resected section must be histologically free of
  • invasive adenocarcinoma and ductal carcinoma in situ.
  • Surgical margins involved with lobular carcinoma in situ (LCIS) will not
  • be considered as a positive margin; therefore, such patients will be eligible for this study without additional resection.
  • Patients must have completed axillary lymph node sampling for the pathologic evaluation of axillary lymph nodes as specified below:
  • Sentinel node biopsy and/or either lymph node sampling procedure or axillary dissection.
  • Multicentric and multifocal invasive breast cancer is eligible if loco-regional surgery has been completed as described above.
  • Patients with synchronous bilateral cancers are eligible only if:
  • All cancers are of triple-negative phenotype, defined as ER-, PR-, HER2-.
  • Eligibility based on the highest stage grouping.
  • HER2 negative tumors. HER2 negativity must be confirmed by one of the
  • following:
  • FISH-negative (FISH ratio \<2.2), or
  • IHC 0-1+, or
  • IHC 2-3+ AND FISH-negative (FISH ratio \<2.2).
  • Estrogen receptor negative (\<10% staining by IHC for estrogen receptor).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Patient must be \<= 84 days from having completed definitive primary breast surgery (either lumpectomy or mastectomy).
  • MammoSite brachytherapy radiation is acceptable if it is performed
  • immediately following surgery and prior to chemotherapy. It is recommended that chemotherapy be started no earlier than 2 weeks following the removal of the MammoSite balloon catheter.
  • Adequate hematologic function, defined by:
  • Absolute neutrophil count (ANC) \>1500/mm3
  • Platelet count \>=100,000/mm3
  • Hemoglobin \>9 g/dL
  • Adequate liver function, defined by:
  • AST and ALT \<=2.5 x the upper limit of normal (ULN)
  • Total bilirubin \<=1.5 x ULN (unless the patient has grade 1 bilirubin
  • elevation due to Gilbert's disease or a similar syndrome involving slow
  • conjugation of bilirubin).
  • Adequate renal function, defined by:
  • Serum creatinine \<=1.5 x ULN
  • Complete staging work-up \<=12 weeks prior to initiation of study treatment
  • with computed tomography (CT) scans of the chest and abdomen/pelvis (abdomen/pelvis preferred; abdomen accepted), and either a positron emission tomography (PET) scan or a bone scan.
  • Adequate cardiac function, defined by a left ventricular ejection fraction
  • (LVEF) value of \>50% (or normal per institutional guidelines) by MUGA scan or echocardiogram (ECHO).
  • Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of a minor surgery (i.e., sentinel node biopsy, port-acath (placement); at least 3 weeks must have elapsed from the time of a major surgery (i.e., lumpectomy, partial or total mastectomy, axillary lymph node dissection, breast reconstruction procedure).
  • Patients with previous history of invasive cancers (including breast cancer)
  • are eligible if definitive treatment was completed more than 5 years prior to
  • initiating current study treatment, and there is no evidence of recurrent disease.
  • Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
  • Patient must be accessible for treatment and follow-up.
  • Women of childbearing potential must agree to use an acceptable method of birth control to avoid pregnancy for the duration of study treatment, and for 3 months thereafter.
  • All patients must be able to understand the investigational nature of the
  • study and give written informed consent prior to study entry.

Exclusion

  • Women who are pregnant or breastfeeding.
  • History of previous diagnosis of invasive breast cancer (unless treated \>5 years previously with no recurrence). History of previously treated ductal carcinoma in situ (DCIS) is acceptable.
  • Any evidence or suspicion of metastatic disease other than ipsilateral
  • axillary lymph nodes.
  • Any tumor \>=T4 (cutaneous invasion, deep adherence, inflammatory breast cancer).
  • Previous anthracycline chemotherapy.
  • Concurrent use of CYP3A4 inhibitors from 72 hours prior to initiation of
  • study treatment until the end of treatment with ixabepilone.
  • Previous treatment for this breast cancer (including neoadjuvant
  • chemotherapy).
  • Previous cancer (with the exception of non-melanoma skin cancer or cervical carcinoma in situ) in the past 5 years (including invasive contralateral breast cancer).
  • Peripheral neuropathy of \> grade 1 per NCI CTCAE v3.0.
  • Cardiac disease, including: congestive heart failure (CHF) \> Class II per
  • New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, cardiac arrhythmia, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • History of hypersensitivity to CremophorEL (polyoxyethylated castor oil) or
  • a drug formulated in CremophorEL such as paclitaxel.
  • Use of any investigational agent within 30 days of administration of the first dose of study drug.
  • Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
  • Concurrent severe, uncontrolled infection or intercurrent illness including,
  • but not limited to, ongoing or active infection, or psychiatric illness/social
  • situations that would limit compliance with study requirements.
  • Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
  • Inability to comply with study and/or follow-up procedures.

Key Trial Info

Start Date :

December 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2016

Estimated Enrollment :

614 Patients enrolled

Trial Details

Trial ID

NCT00789581

Start Date

December 1 2008

End Date

November 1 2016

Last Update

July 2 2017

Active Locations (70)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 18 (70 locations)

1

Northeast Alabama Regional Medical Center

Anniston, Alabama, United States, 36207

2

Cancer Center of Huntsville

Huntsville, Alabama, United States, 35801

3

Clearview Cancer Institute

Huntsville, Alabama, United States, 35805

4

University of Southern Alabama

Mobile, Alabama, United States, 36604