Know Cancer

forgot password

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.

Phase 3
18 Years
70 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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.



- 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.


- 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.

- Arm I: 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.

- Arm II: 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.

Inclusion Criteria


Inclusion criteria:

- 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

Exclusion criteria:

- 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


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

- 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


- At least 2 weeks since prior minor surgery (excluding breast biopsy) and adequately

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival (DFS) defined as a local, regional, or metastatic relapse, a contralateral breast cancer, or a death of any cause

Outcome Time Frame:

at 5 years

Safety Issue:


Principal Investigator

Mario Campone, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

ICO Centre Regional Rene Gauducheau


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

PACS08 - UC-0140/0610



Start Date:

September 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms



Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Colorado Cancer Research Program Denver, Colorado  80224-2522
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
Duluth Clinic Cancer Center - Duluth Duluth, Minnesota  55805-1983
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
CCOP - Dayton Kettering, Ohio  45429
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Roger Maris Cancer Center at MeritCare Hospital Fargo, North Dakota  58122
Southeast Nebraska Hematology Oncology Consultants at Southeast Nebraska Cancer Center Lincoln, Nebraska  68510
Oncology Associates at Rapid City Regional Hospital Rapid City, South Dakota  57701