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

Completed · Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00630032

Run by

UNICANCER

People needed

762

Starts

2007-09-01

Expected to finish

2020-09-03

Last updated by the study team

2024-02-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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:
• Inclusion criteria:
• 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
• Exclusion criteria:
• Previous cancer (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) in the preceding 5 years, including invasive contralateral breast cancer

Where it is running

• CCOP - Colorado Cancer Research Program — Denver, Colorado, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• CCOP - Northern Indiana CR Consortium — South Bend, Indiana, United States
• CCOP - Cedar Rapids Oncology Project — Cedar Rapids, Iowa, United States
• Siouxland Hematology-Oncology Associates, LLP — Sioux City, Iowa, United States
• Cancer Center of Kansas, PA - Wichita — Wichita, Kansas, United States
• Duluth Clinic Cancer Center - Duluth — Duluth, Minnesota, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• CCOP - Metro-Minnesota — Saint Louis Park, Minnesota, United States
• Southeast Nebraska Hematology Oncology Consultants at Southeast Nebraska Cancer Center — Lincoln, Nebraska, United States
• CCOP - Missouri Valley Cancer Consortium — Omaha, Nebraska, United States
• Roger Maris Cancer Center at MeritCare Hospital — Fargo, North Dakota, United States
• CCOP - Dayton — Dayton, Ohio, United States
• CCOP - Geisinger Clinic and Medical Center — Danville, Pennsylvania, United States
• Oncology Associates at Rapid City Regional Hospital — Rapid City, South Dakota, United States
• Green Bay Oncology, Limited at St. Mary's Hospital — Green Bay, Wisconsin, United States
• Institut Jules Bordet — Brussels, Belgium
• Centre de Sante des Fagnes — Chimay, Belgium
• Centre Hospitalier Hutois — Huy, Belgium
• Cazk Groeninghe - Campus Maria's Voorzienigheid — Kortrijk, Belgium
• CHR - Clinique Saint Joseph - Hopital de Warqueguies — Mons, Belgium
• Clinique Saint-Pierre — Ottignies, Belgium
• Clinique Universitaire De Mont-Godinne — Yvoir, Belgium
• Clinique Claude Bernard — Albi, France
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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