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

NCT00630032 | Completed Phase 3 Results DMC

• 6 other identifiers: PACS08 - UC-0140/0610PACS-08/06102006-006494-24PACS08-TavlxBMS-UNICANCER-PACS-08/0610AMGEN-UNICANCER-PACS-08/0610
• Study Type: interventional
• Target: 762
• Locations: 3 countries
• Sites: 86

Brief 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. 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.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (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

  At 5 years

Secondary Outcomes (5)

• Number of Disease-free Survival Events for Triple-negative Subgroup

  At 5 years

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

  At 5 years

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

  At 5 years

• Number of Event-free Survival

  At 5 years

• Overall Survival

  At 5 years

Study Arms (2)

Docetaxel

ACTIVE COMPARATOR

3 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)

Drug: cyclophosphamide; Drug: Docetaxel; Drug: epirubicin hydrochloride; Drug: fluorouracil

Ixabepilone

EXPERIMENTAL

3 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);

Drug: cyclophosphamide; Drug: epirubicin hydrochloride; Drug: fluorouracil; Drug: ixabepilone

Interventions

cyclophosphamide DRUG

500 mg/m² every 3 weeks

Docetaxel; Ixabepilone

Docetaxel DRUG

100 mg/m² every 3 weeks

Docetaxel

epirubicin hydrochloride DRUG

100 mg/m² every 3 weeks

Docetaxel; Ixabepilone

fluorouracil DRUG

500 mg/m² every 3 weeks

Docetaxel; Ixabepilone

ixabepilone DRUG

40 mg/m² every 3 weeks

Ixabepilone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• PATIENT CHARACTERISTICS:
• 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)

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (86)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

CCOP - Colorado Cancer Research Program

Denver, Colorado, 80224, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101-1733, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214-3728, United States

Location

Duluth Clinic Cancer Center - Duluth

Duluth, Minnesota, 55805-1983, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Southeast Nebraska Hematology Oncology Consultants at Southeast Nebraska Cancer Center

Lincoln, Nebraska, 68510, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Roger Maris Cancer Center at MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Oncology Associates at Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

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

Green Bay, Wisconsin, 54303, United States

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Centre de Sante des Fagnes

Chimay, B-6460, Belgium

Location

Centre Hospitalier Hutois

Huy, 4500, Belgium

Location

Cazk Groeninghe - Campus Maria's Voorzienigheid

Kortrijk, B-8500, Belgium

Location

CHR - Clinique Saint Joseph - Hopital de Warqueguies

Mons, B-7000, Belgium

Location

Clinique Saint-Pierre

Ottignies, B-1340, Belgium

Location

Clinique Universitaire De Mont-Godinne

Yvoir, 5530, Belgium

Location

Clinique Claude Bernard

Albi, 81000, France

Location

Centre Paul Papin

Angers, 49036, France

Location

Centre Hospitalier d'Annecy

Annecy, 74011 Cedex, France

Location

Centre Hospitalier d'Auxerre

Auxerre, 89011, France

Location

Institut Sainte Catherine

Avignon, 84082, France

Location

Centre Hospitalier de Blois

Blois, 41000, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Clinique Tivoli

Bordeaux, F-33000, France

Location

Centre Hospitalier Docteur Duchenne

Boulogne-sur-Mer, 62200, France

Location

Centre Hospitalier de Fleyriat

Bourg-en-Bresse, 01012, France

Location

CHU Hopital A. Morvan

Brest, 29609, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Hospitalier Regional de Chambery

Chambéry, 73011, France

Location

Centre Hospitalier de Chateaubriant

Châteaubriant, 44110, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Clinique des Cedres

Cornebarrieu, 31700, France

Location

Hopital Intercommunal De Creteil

Créteil, 94010, France

Location

Centre Hospitalier de Dax

Dax, 40107, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Clinique Claude Bernard

Ermont, 95120, France

Location

Hopital Jean Monnet

Épinal, 88021, France

Location

Hopital Andre Mignot

Le Chesnay, 78157, France

Location

CMC Les Ormeaux

Le Havre, 76600, France

Location

Polyclinique des Quatre Pavillons

Lormont, 33310, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Centre de Radiotherapie et Oncologie Saint-Faron

Mareuil-lès-Meaux, 77100, France

Location

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

Marseille, 13273, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 57038, France

Location

Hopital Clinique Claude Bernard

Metz, 57070, France

Location

Centre Hospitalier General de Mont de Marsan

Mont-de-Marsan, 40000, France

Location

Clinique du Pont de Chaume

Montauban, 82017, France

Location

Centre Hospitalier Intercommunal Le Raincy - Montfermeil

Montfermeil, 93370, France

Location

Centre Hospitalier de Montlucon

Montluçon, 03113, France

Location

Centre Hospitalier

Mulhouse, 68070, France

Location

Clinique D'Occitanie

Muret, 31600, France

Location

Clinique Hartmann

Neuilly-sur-Seine, 92200, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Clinique De Valdegour

Nîmes, 30907, France

Location

Hopital Saint Michel

Paris, 75015, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Centre Hospitalier - Pau

Pau, 64046, France

Location

Centre Hospitalier de Perpignan

Perpignan, 66000, France

Location

Polyclinique Francheville

Périgueux, 24004, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre Hospitalier de Rodez

Rodez, 12027, France

Location

Clinique Armoricaine De Radiologie

Saint-Brieuc, F-22015, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

Centre Regional Rene Gauducheau

Saint-Herblain, 44805, France

Location

Clinique de l'Union

Saint-Jean, 31240, France

Location

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, 42270, France

Location

Clinique de l'Orangerie

Strasbourg, 67000, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Polyclinique de L'Ormeau

Tarbes, 65000, France

Location

Centre Hospitalier Regional Metz Thionville

Thionville, 57312, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Clinique Du Parc

Toulouse, 31078, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Centre d'Oncologie Saint-Yves

Vannes, 56001, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Links

• Abstract primary endpoint results

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil; ixabepilone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Deputy Director R&D
• Organization: Unicancer

b-juzyna@unicancer.fr

(+33)1 44 23 04 19

Study Officials

• Mario Campone, MD

  ICO Centre Regional Rene Gauducheau

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: March 6, 2008
• Study Start: September 1, 2007
• Primary Completion: June 1, 2017
• Study Completion: September 3, 2020
• Last Updated: February 21, 2024
• Results First Posted: March 16, 2021

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
• Access Criteria: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.

Locations

US (17); FR (62); BE (7)