Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–70
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically proven breast cancer at the first diagnosis with \> or = 4 axillary nodes showing evidence of tumor among a minimum of 10 resected lymph nodes (American Joint Committee on Cancer 1992 pathologic staging pT1-4, pN1-2 \[at least 1/10\], M0)
Ages ≥ 18 years and ≤ 70 years for patients who will be randomized to arm A and B. Ages ≥ 18 years and ≤ 65 years for patients who will be randomized to arm C
World Health Organization performance status 0-1
Definitive surgical treatment must be either mastectomy or breast conserving surgery, with axillary lymph node dissection for operable breast cancer (clinical T1-3, N1, M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ. Lobular carcinoma in situ does not count as a positive margin. Patients with histologically-documented infiltration of the skin (pT4a) will be also eligible
Surgical procedures completed within 8 weeks from the randomization.
Laboratory requirements:
* Hematology :
* Neutrophils ≥ 2 x 10\^9/L
* Platelets ≥ 100 x 10\^9/L
* Hemoglobin ≥ 10 g/DL
* Hepatic function:
* Total bilirubin ≤ 1 time the upper-normal limits of the institutional normal values.
Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception)
History of prior or concomitant malignancies other than curatively treated basal cell skin cancer or excised cervical carcinoma in situ
Symptomatic peripheral neuropathy \> grade 2 according to the National Cancer Institute Common Toxicity Criteria
Other serious illnesses or medical conditions:
* Congestive heart failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmias
* History of significant neurologic or psychiatric disorders including dementia or seizures
* Active infection
* Peptic ulcer, unstable diabetes mellitus or other contraindications for the use of dexamethasone
Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational regimen within 30 days prior to study entry
Concurrent treatment with any other anti-cancer therapy
Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry
Prior systemic anticancer therapy for breast cancer (chemotherapy, hormonal therapy, immunotherapy, etc.) as adjuvant and/or neo-adjuvant therapy
Concomitant treatment with corticosteroids used for reasons other than premedication; however, patients receiving chronic treatment with corticosteroids (\>6 months) at low dose (≤ 20 mg of methylprednisolone or equivalent dose of other corticosteroids) for whichever reason are eligible
Definite contraindications for the use of corticosteroids as premedication
Prior radiation therapy
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
You may not be if
* Renal function :
* Creatinine ≤ 140 µmol/L (1.6 mg/DL); if limit values, the creatinine clearance should be performed and should be ≥ 60 ml/min
Normal left ventricular ejection fraction or superior to the lower limits of the institution
Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating center
Complete work-up within 3 months prior to randomization. All patients will have bilateral mammography, chest X rays (posteroanterior \[PA\] and lateral), abdominal ultrasound and/or computed tomography scan, \& bone scan
Axillary lymph nodes free of involvement
Primary breast cancer with histology other than adenocarcinoma
Inflammatory carcinoma
Any locally advanced (T4 and/or N2-known N3) or metastatic (M1) breast cancer
Past or current history of ipsilateral or contralateral invasive or contralateral ductal in situ breast carcinoma. A past or current history of ipsilateral ductal in situ or lobular in situ (ipsilateral or contralateral) breast carcinoma is not an exclusion criterion
Clareo Health | Study of Docetaxel in Breast Cancer Patients
