Status:
COMPLETED
ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Breast Cancer
Eligibility:
FEMALE
65-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare disease free survival of elderly breast cancer patients treated with standard adjuvant chemotherapy (CMF) versus experimental adjuvant chemotherapy (weekly doce...
Detailed Description
Adjuvant combination chemotherapy, given after breast cancer surgery, has been established as the standard approach to reduce the risk of breast cancer recurrence in those patients at intermediate or ...
Eligibility Criteria
Inclusion
- Histologically confirmed invasive unilateral breast cancer
- Age \> 65 and \< 80 years
- Intermediate-high risk of recurrence according to St. Gallen criteria: ER negative and PgR negative, or axillary lymph node metastasis, or tumor size \> 2 cm, or tumor grade 2 or 3 (intermediate or high)
Exclusion
- Performance status \>1
- Distant metastasis
- Concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated
- Previous breast cancer treatment
- Neutrophils \< 2000/mm3 or platelets \< 100000/mm3 or haemoglobin \< 10 g/dl
- Creatinine \> 1.25 the upper normal limit
- GOT and-or GPT and/or bilirubin \> 1.25 the upper normal limit
- Concomitant conditions that contraindicate the use of the drugs in the protocol
- Incapacity or refusal to provide informed consent
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00331097
Start Date
July 1 2003
End Date
November 1 2014
Last Update
March 28 2017
Active Locations (8)
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1
Azienda Sanitaria S. Giuseppe Moscati
Monteforte Irpino, AV, Italy
2
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy
3
Policlinico Monteluce
Sant'Andrea Delle Frate, PG, Italy
4
Azienda Ospedaliera Cardarelli
Napoli, Italy, 80131