Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT00630032
Eligibility Criteria:
DISEASE CHARACTERISTICS:
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 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
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00630032
Study Brief:
Protocol Section:
NCT00630032