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Breast CancerPhase 3TavIxNCT00630032

Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer

A Phase 3 study testing cyclophosphamide, Docetaxel and epirubicin hydrochloride in people with Breast Cancer, run by UNICANCER at 86 sites in 3 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

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them after surgery may kill any tumor cells remaining after surgery. 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?
cyclophosphamide, Docetaxel and epirubicin hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
762 participants
Where
86 sitesin 3 countries
Study dates
Sep 2007to 3 Sep 2020
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

  • Histologically proven invasive unilateral breast cancer (regardless of the type)
  • Initial clinical condition compatible with complete initial resection
  • No residual macro or microscopic tumor after surgical excision
  • Node-positive disease (i.e., positive sentinel node or positive axillary clearance) (N+) or node-negative disease (-) meeting the following criteria :
  • Stage II or III disease
  • pT >20 mm (T1-4)
Show all 26Show fewer
  • Patients must meet 1 of the following hormone-receptor criteria:
  • Node-positive patients: triple-negative* tumor (HER2 negative, estrogen-receptor [ER] negative, and progesterone receptor [PR] negative) OR double-negative (HER2 negative, PR negative, and ER+)
  • Node-negative patients: triple-negative* tumor only
  • NOTE: *Hormone-receptor negativity is defined as ER <10% and PR <10% by IHC and HER2 negativity is defined as IHC 0-1+ OR IHC 2+ and FISH or CISH negative
  • Must be able to begin chemotherapy no later than day 49 after the initial surgery
  • Female
  • Pre- or postmenopausal
  • ECOG performance status 0-1
  • Peripheral neuropathy ≤grade 1
  • Neutrophil count ≥2,000/mm³
  • Platelet count ≥100,000/mm³
  • Hemoglobin >9 g/dL
  • AST and ALT ≤1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤2.5 times ULN
  • Total bilirubin ≤1.0 times ULN
  • Serum creatinine ≤1.5 times ULN
  • LVEF ≥50% by MUGA scan or echocardiography
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment

Who cannot join

  • Clinically or radiologically detectable metastases (M0)
  • Bilateral breast cancer or contralateral ductal carcinoma in situ
  • Any metastatic impairment, including homolateral subclavicular node involvement, regardless of its type
  • Any tumor ≥T4a (cutaneous invasion, deep adherence, inflammatory breast cancer)
  • HER 2 overexpression defined as IHC 3+ OR IHC 2+ and FISH or CISH positive
  • Any clinically or radiologically suspect and non-explored damage to the contralateral breast
Show all 37Show fewer
  • PATIENT CHARACTERISTICS:
  • Previous cancer (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) in the preceding 5 years, including invasive contralateral breast cancer
  • Patients with any other concurrent severe and/or uncontrolled medical disease or infection that could compromise participation in the study
  • Clinically significant cardiovascular disease within the past 6 months including any of the following:
  • Unstable angina
  • Congestive heart failure
  • Uncontrolled hypertension (i.e., blood pressure >150/90 mm Hg)
  • Myocardial infarction
  • Cerebral vascular accidents
  • Known prior severe hypersensitivity reactions to agents containing Cremophor EL
  • Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Patients deprived of liberty or placed under the authority of a tutor
  • PRIOR CONCURRENT THERAPY:
  • At least 2 weeks since prior minor surgery (excluding breast biopsy) and adequately recovered
  • At least 3 weeks since prior major surgery and adequately recovered
  • No prior chemotherapy, hormonal therapy, or radiotherapy
  • More than 72 hours since prior and no concurrent treatment with any of the following strong inhibitors of CYP3A4:
  • Amiodarone
  • Clarithromycin
  • Amprenavir
  • Delavirdine
  • Voriconazole
  • Erythromycin
  • Fluconazole
  • Itraconazole
  • Ketoconazole
  • Indinavir
  • Nelfinavir
  • Ritonavir
  • Saquinavir
  • No concurrent participation in another therapeutic trial involving an experimental drug

Trial locations and contacts

86 sites in 3 countries.

86 sites in 3 countries

France62 sites

  • Clinique Claude Bernard

    Albi, 81000

  • Centre Paul Papin

    Angers, 49036

  • Centre Hospitalier d'Annecy

    Annecy, 74011 Cedex

  • Centre Hospitalier d'Auxerre

    Auxerre, 89011

  • Institut Sainte Catherine

    Avignon, 84082

  • Centre Hospitalier de Blois

    Blois, 41000

  • Institut Bergonie

    Bordeaux, 33076

  • Clinique Tivoli

    Bordeaux, F-33000

  • Centre Hospitalier Docteur Duchenne

    Boulogne-sur-Mer, 62200

  • Centre Hospitalier de Fleyriat

    Bourg-en-Bresse, 01012

  • CHU Hopital A. Morvan

    Brest, 29609

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Hospitalier Regional de Chambery

    Chambéry, 73011

  • Centre Hospitalier de Chateaubriant

    Châteaubriant, 44110

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Clinique des Cedres

    Cornebarrieu, 31700

  • Hopital Intercommunal De Creteil

    Créteil, 94010

  • Centre Hospitalier de Dax

    Dax, 40107

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Hopital Jean Monnet

    Épinal, 88021

  • Clinique Claude Bernard

    Ermont, 95120

  • Hopital Andre Mignot

    Le Chesnay, 78157

  • CMC Les Ormeaux

    Le Havre, 76600

  • Polyclinique des Quatre Pavillons

    Lormont, 33310

  • Centre Leon Berard

    Lyon, 69373

  • Centre de Radiotherapie et Oncologie Saint-Faron

    Mareuil-lès-Meaux, 77100

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, 13273

  • Hopital Notre-Dame de Bon Secours

    Metz, 57038

  • Hopital Clinique Claude Bernard

    Metz, 57070

  • Centre Hospitalier General de Mont de Marsan

    Mont-de-Marsan, 40000

  • Clinique du Pont de Chaume

    Montauban, 82017

  • Centre Hospitalier Intercommunal Le Raincy - Montfermeil

    Montfermeil, 93370

  • Centre Hospitalier de Montlucon

    Montluçon, 03113

  • Centre Hospitalier

    Mulhouse, 68070

  • Clinique D'Occitanie

    Muret, 31600

  • Clinique Hartmann

    Neuilly-sur-Seine, 92200

  • Centre Antoine Lacassagne

    Nice, 06189

  • Clinique De Valdegour

    Nîmes, 30907

  • Hopital Saint Michel

    Paris, 75015

  • Institut Curie Hopital

    Paris, 75248

  • Centre Hospitalier - Pau

    Pau, 64046

  • Polyclinique Francheville

    Périgueux, 24004

  • Centre Hospitalier de Perpignan

    Perpignan, 66000

  • Institut Jean Godinot

    Reims, 51056

  • Polyclinique De Courlancy

    Reims, F-51100

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Hospitalier de Rodez

    Rodez, 12027

  • Clinique Armoricaine De Radiologie

    Saint-Brieuc, F-22015

  • Centre Rene Huguenin

    Saint-Cloud, 92211

  • Centre Regional Rene Gauducheau

    Saint-Herblain, 44805

  • Clinique de l'Union

    Saint-Jean, 31240

  • Institut de Cancerologie de la Loire

    Saint-Priest-en-Jarez, 42270

  • Clinique de l'Orangerie

    Strasbourg, 67000

  • Centre Paul Strauss

    Strasbourg, 67065

  • Polyclinique de L'Ormeau

    Tarbes, 65000

  • Centre Hospitalier Regional Metz Thionville

    Thionville, 57312

  • Institut Claudius Regaud

    Toulouse, 31052

  • Clinique Du Parc

    Toulouse, 31078

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Centre d'Oncologie Saint-Yves

    Vannes, 56001

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

United States17 sites

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • CCOP - Geisinger Clinic and Medical Center

    Danville, Pennsylvania, 17822-2001

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • CCOP - Colorado Cancer Research Program

    Denver, Colorado, 80224

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • Roger Maris Cancer Center at MeritCare Hospital

    Fargo, North Dakota, 58122

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Southeast Nebraska Hematology Oncology Consultants at Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Oncology Associates at Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101-1733

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214-3728

Other trials in United States

Belgium7 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Centre de Sante des Fagnes

    Chimay, B-6460

  • Centre Hospitalier Hutois

    Huy, 4500

  • Cazk Groeninghe - Campus Maria's Voorzienigheid

    Kortrijk, B-8500

  • CHR - Clinique Saint Joseph - Hopital de Warqueguies

    Mons, B-7000

  • Clinique Saint-Pierre

    Ottignies, B-1340

  • Clinique Universitaire De Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

About this study

Official title: Randomized, Open Label, Multicentric Phase III Evaluating the Benefit of a Sequential Regimen Associating FEC 100 and Ixabepilone in Adjuvant Treatment of Non Metastatic, Poor Prognosis Breast Cancer Defined as Triple-negative Tumor [HER2 Negative - ER Negative - PR Negative] or [HER2 Negative and PR Negative] Tumor; in Node Positive or Node Negative Patients.

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known whether docetaxel is more effective than ixabepilone when given after surgery and combination chemotherapy in treating breast cancer.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy followed by docetaxel or ixabepilone to compare how well they work in treating patients who have undergone surgery for nonmetastatic breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To evaluate the benefit from sequential administration of 3 courses of combination chemotherapy (FEC100) followed by 3 courses of ixabepilone versus docetaxel on the 5-year disease-free survival of women with nonmetastatic, poor-prognosis breast cancer.

Secondary

  • To compare the 5-year distant metastasis-free survival.
  • To compare the 5-year event-free survival.
  • To compare the 5-year overall survival.
  • To compare the safety profiles for the two chemotherapy regimens.
  • To identify and/or validate predictive-gene expression profiles of clinical response/resistance to the two treatment regimens.
  • To bank frozen and fixed tumor and frozen serum prospectively for future translational studies in both genomics and proteomics (transcriptome and proteome analyses, tissue array analyses).
  • To compare the cost-effectiveness of these 2 regimens.
  • To compare the quality-of-life of patients treated with these 2 regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs post-menopausal), and tumor hormone-receptor status (triple-negative vs progesterone-receptor negative, HER negative, and estrogen-receptor [ER] positive). Patients are randomized to 1 of 2 treatment arms.

  • Docetaxel Arm: Patients receive epirubicin hydrochloride IV, fluorouracil IV, and cyclophosphamide IV every 3 weeks in courses 1-3 and docetaxel IV alone every 3 weeks in courses 4-6.
  • Ixabepilone Arm: Patients receive treatment in courses 1-3 as in arm I and ixabepilone IV alone every 3 weeks in courses 4-6.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients also complete a quality of life questionnaire periodically.

After completion of study treatment, patients are followed periodically for up to 10 years.

Conditions
Breast Cancer
Being tested
cyclophosphamide, Docetaxel, epirubicin hydrochloride, fluorouracil, ixabepilone
Keywords
stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

  • cyclophosphamideDrug

    500 mg/m² every 3 weeks

  • DocetaxelDrug

    100 mg/m² every 3 weeks

  • epirubicin hydrochlorideDrug

    100 mg/m² every 3 weeks

  • fluorouracilDrug

    500 mg/m² every 3 weeks

  • ixabepiloneDrug

    40 mg/m² every 3 weeks

Study groups in NCT00630032
Study groupRoleWhat they receive
DocetaxelActive comparator3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)
Receives: Drug: cyclophosphamide; Drug: Docetaxel; Drug: epirubicin hydrochloride; Drug: fluorouracil
IxabepiloneExperimental3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
Receives: Drug: cyclophosphamide; Drug: epirubicin hydrochloride; Drug: fluorouracil; Drug: ixabepilone

What is being measured

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

  1. Percentage of Participants With Disease-free Survival (DFS)

    DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first

    Measured: At 5 years

Secondary outcomes (5)

  1. Number of Disease-free Survival Events for Triple-negative Subgroup

    DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first in participants with triple negative breast cancer only.

    Measured: At 5 years

  2. Number of Disease-free Survival Events for ER+/PR-/HER2- Subgroup

    DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first in participants with ER+/PR-/HER2- breast cancer only.

    Measured: At 5 years

  3. Number of Distant Metastasis-free Survival Events for the Whole Population

    The distant metastases-free survival is the length of time during and after the treatment for cancer that a patient is still alive and the cancer has not spread to other parts of the body.

    Measured: At 5 years

  4. Number of Event-free Survival

    The Event-free Survival is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or the date of second neoplasia, or the date of death from any cause, whichever occurs first.

    Measured: At 5 years

  5. Overall Survival

    The overall survival is the length of time from randomization that patients enrolled in the study are still alive.

    Measured: At 5 years

Timeline

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

  1. First posted6 Mar 2008 (estimated)
  2. Study startSep 2007
  3. Primary completionJun 2017
  4. Study completion3 Sep 2020

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
762 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00630032
Sponsor's protocol ID
PACS08 - UC-0140/0610
Other IDs
PACS-08/0610, 2006-006494-24, PACS08-Tavlx, BMS-UNICANCER-PACS-08/0610, AMGEN-UNICANCER-PACS-08/0610
Acronym
TavIx
Status last verified
Feb 2024
First submitted
5 Mar 2008
Last updated
21 Feb 2024
Data monitoring committee
Yes
Individual data sharing
Yes: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cyclophosphamide, Docetaxel and epirubicin hydrochloride in people with Breast Cancer, run by UNICANCER at 86 sites in 3 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 26 inclusion and 37 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 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in France, United States, Belgium. 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 16 Mar 2021). 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?

Percentage of Participants With Disease-free Survival (DFS) (time frame: At 5 years). 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 NCT00630032.

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 21 Feb 2024.

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