Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Radboud University Medical Center
With
Sanofi
Amgen
Age
18–70
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Women presenting with large resectable or locally advanced breast cancer (T2 ≥3 cm, T3, or T4, and/or LN positive)
Measurable disease (breast and/or lymph nodes)
No prior surgery other than biopsy and no prior chemotherapy or radiation therapy
Age ≥18 years and age ≤70 years
Karnofsky Performance score ≥70%
Estrogen and/or progesterone receptor analysis performed on the primary tumour in the biopsy material
In case the tumor is ER/PgR ³ 50% positive, (neo)adjuvant hormonal therapy in stead of chemotherapy should be considered (e.g. in TEAM II study)
Her2/neu receptor analysis performed on the primary tumour in the biopsy material
Adequate bone marrow function (within 14 days prior to registration): WBC ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
Adequate liver function (within 4 weeks prior to start treatment): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
Adequate renal function (within 4 weeks prior to start treatment): the calculated creatinine clearance should be ≥50 mL/min
Patients must be accessible for treatment and follow-up
Written informed consent according to the local Ethics Committee requirements
You may not be if
Patients with advanced pulmonary disease of any cause (oxygen dependent)- Peripheral neuropathy \> grade 2 whatever the cause
Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrythmias
Evidence of distant metastases (M1)
Patients with a history of breast cancer
Patients with a history of another malignancy (except basal cell skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry- Pregnant or lactating women, or potentially fertile women not using adequate contraception
Clareo Health | Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable or Locally Advanced Breast Cancer.
