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Breast CancerPhase 3TITANNCT00789581

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

A Phase 3 study testing Doxorubicin, Cyclophosphamide and Ixabepilone (Ixempra) in people with Breast Cancer, run by SCRI Development Innovations, LLC at 70 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomized, Phase III, open-label, multicenter study. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Doxorubicin, Cyclophosphamide and Ixabepilone (Ixempra)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
614 participants
Where
70 sitesin 2 countries
Study dates
Dec 2008to Nov 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

70 sites in 2 countries.

70 sites in 2 countries

United States69 sites

  • New Mexico Oncology Hematology Consultants

    Albuquerque, New Mexico, 87109

  • Northeast Alabama Regional Medical Center

    Anniston, Alabama, 36207

  • Piedmont Healthcare

    Atlanta, Georgia, 30309

  • Emory/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Augusta Oncology Associates

    Augusta, Georgia, 30901

  • Medical Oncology Associates of Augusta

    Augusta, Georgia, 30901

  • Medical College of Georgia Cancer Specialists

    Augusta, Georgia, 30912

  • Aventura Medical Center

    Aventura, Florida, 33180

  • Weinberg Cancer Institute at Franklin Square

    Baltimore, Maryland, 21237

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70806

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Lynn Cancer Institute

    Boca Raton, Florida, 33428

  • Alamance Regional Medical Center

    Burlington, North Carolina, 27215

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Associates in Hematology Oncology

    Chattanooga, Tennessee, 37404

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • St. Louis Cancer Care

    Chesterfield, Missouri, 63017

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Family Cancer Center

    Collierville, Tennessee, 38017

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, 29210

  • Mid Ohio Oncology/Hematology, Inc./ The Mark H. Zangmeister Center

    Columbus, Ohio, 43219

  • Coastal Bend Cancer Center

    Corpus Christi, Texas, 78463

  • Florida Cancer Care

    Davie, Florida, 33328

  • St. Clare's Hospital Oncology and Hematology

    Denville, New Jersey, 07834

  • Fairview Medical Oncology Clinic

    Edina, Minnesota, 55436

  • Hematology/Oncology Inc

    Elyria, Ohio, 44035

  • Oncology Hematology Associates of SW Indiana

    Evansville, Indiana, 47714

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Memorial Regional Cancer Center

    Hollywood, Florida, 33021

  • Medical Oncology Methodist Hospital

    Houston, Texas, 77030

  • Cancer Center of Huntsville

    Huntsville, Alabama, 35801

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • Hematology Oncology of Indiana

    Indianapolis, Indiana, 46260

  • Integrated Community Oncology Network

    Jacksonville, Florida, 32256

  • Northeast Arkansas Clinic

    Jonesboro, Arkansas, 72401

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Wilshire Oncology Medical Group

    La Verne, California, 91750

  • Watson Clinic Center for Cancer Care and Research

    Lakeland, Florida, 33805

  • Suburban Hem Onc

    Lawrenceville, Georgia, 30045

  • Consultants in Blood Disorders and Cancer

    Louisville, Kentucky, 40207

  • University of Southern Alabama

    Mobile, Alabama, 36604

  • Hematology Oncology Associates of Northern NJ

    Morristown, New Jersey, 07960

  • Lowcountry Hematology Oncology

    Mt. Pleasant, South Carolina, 29464

  • Coastal Cancer Center

    Myrtle Beach, South Carolina, 29572

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601

  • Mid-Illinois Hematology & Oncology

    Normal, Illinois, 61761

  • Eastern Connecticut Hematology Oncology

    Norwich, Connecticut, 06360

  • Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Kansas City Cancer Centers

    Overland Park, Kansas, 66210

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • New Hope Cancer and Research Institute

    Pomona, California, 91767

  • Mercy Hospital

    Portland, Maine, 04101

  • Virginia Cancer Institute

    Richmond, Virginia, 23235

  • Bux-Mont Oncology, Fox Chase Cancer Center

    Rockledge, Pennsylvania, 18960

  • South Texas Oncology and Hematology

    San Antonio, Texas, 78258

  • Hematology Oncology of the North Shore

    Skokie, Illinois, 60076

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • St. John's Clinic

    Springfield, Missouri, 65804

  • Hickman Cancer Center (Flower Hospital)

    Sylvania, Ohio, 43560

  • Providence Medical Group

    Terre Haute, Indiana, 47802

  • Space Coast Medical Associates

    Titusville, Florida, 32796

  • Cotton O'Neil Cancer Center

    Topeka, Kansas, 66606

  • Southern Oncology and Hematology

    Vineland, New Jersey, 08360

  • Fallon Clinic

    Worcester, Massachusetts, 01608

Other trials in United States

Puerto Rico1 site

  • San Juan Hospital

    San Juan

Other trials in Puerto Rico

About this study

Official title: Phase III Study of Doxorubicin/Cyclophosphamide (AC) Followed by Ixabepilone vs. AC Followed by Paclitaxel in Patients With Triple-Negative Early-Stage Breast Cancer

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

Read the 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 AC followed by weekly paclitaxel.

Conditions
Breast Cancer
Being tested
Doxorubicin, Cyclophosphamide, Ixabepilone (Ixempra), Paclitaxel (Taxol)
Keywords
Breast Cancer, Adjuvant, Doxorubicin, Cyclophosphamide, Paclitaxel, Ixabepilone, TITAN
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoxorubicinDrug

    Also called Adriamycin, hydroxydaunorubicin, Adriamycin PFS, Adriamycin RDF

    Doxorubicin 60 mg/m2

  • CyclophosphamideDrug

    Also called Endoxan, Cytoxan, Neosar, Procytox

    Cyclophosphamide 600 mg/m2

  • Ixabepilone (Ixempra)Drug

    Also called Ixempra, azaepothilone B, BMS-247550

    Ixabepilone 40 mg/m2

  • Paclitaxel (Taxol)Drug

    Also called Taxol

    Paclitaxel 80 mg/m2

Study groups in NCT00789581
Study groupRoleWhat they receive
Doxorubicin/cyclophosphamide, ixabepiloneExperimentalDoxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by ixabepilone at 40 mg/m2 given for 4 cycles of 21 days each.
Receives: Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Ixabepilone (Ixempra)
Doxorubicin/cyclophosphamide, paclitaxelActive comparatorDoxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by paclitaxel at 80 mg/m2 weekly for 12 weeks.
Receives: Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Paclitaxel (Taxol)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free Survival

    The percentage of participants with disease-free survival at 3 and 5 years. Disease-free survival (DFS) is measured from the time between randomization and the date of first documented disease recurrence, or death from any cause.

    Measured: up to 5.25 years (63 months)

Secondary outcomes (1)

  1. Overall Survival

    The percentage of participants with overall survival at 3 and 5 years are presented. Overall survival (OS) defined as the time between randomization to date of death from any cause.

    Measured: up to 5.25 years (63 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionDec 2015
  4. Study completionNov 2016

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
614 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00789581
Sponsor's protocol ID
SCRI BRE 145
Other IDs
TITAN
Acronym
TITAN
Status last verified
Jun 2017
First submitted
11 Nov 2008
Last updated
2 Jul 2017
Data monitoring committee
Yes

Publications

  • Yardley DA, Arrowsmith ER, Daniel BR, Eakle J, Brufsky A, Drosick DR, Kudrik F, Bosserman LD, Keaton MR, Goble SA, Bubis JA, Priego VM, Pendergrass K, Manalo Y, Bury M, Gravenor DS, Rodriguez GI, Inhorn RC, Young RR, Harwin WN, Silver C, Hainsworth JD, Burris HA 3rd. TITAN: phase III study of doxorubicin/cyclophosphamide followed by ixabepilone or paclitaxel in early-stage triple-negative breast cancer. Breast Cancer Res Treat. 2017 Aug;164(3):649-658. doi: 10.1007/s10549-017-4285-6. Epub 2017 May 15.

    PubMed 28508185

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Doxorubicin, Cyclophosphamide and Ixabepilone (Ixempra) in people with Breast Cancer, run by SCRI Development Innovations, LLC at 70 sites in 2 countries.

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 54 inclusion and 23 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: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Disease-free Survival (time frame: up to 5.25 years (63 months)). 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 NCT00789581, 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 2 Jul 2017.

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