Status:
COMPLETED
Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable or Locally Advanced Breast Cancer.
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Sanofi
Amgen
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
2 different treatment schedules may be used for neoadjuvant chemotherapy in breast cancer using adriamycin, cyclophosphamide and taxotere. The most optimal sequence- concurrent or sequential- is howev...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00314977
Start Date
February 1 2006
Last Update
March 18 2010
Active Locations (24)
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1
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
2
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
3
Rijnstate Ziekenhuis
Arnhem, Netherlands
4
Deventer Ziekenhuis
Deventer, Netherlands