Status:
COMPLETED
Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel as Neoadjuvant Treatment of Breast Cancer Patients
Lead Sponsor:
Spanish Breast Cancer Research Group
Collaborating Sponsors:
Sanofi
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
Treatment consists of 4 AC cycles followed by 2 weekly docetaxel cycles (12 infusions). The pathological complete response rate obtained in previous studies is around 12%. The expected pathological c...
Detailed Description
Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles (days 1, 22, 43 and 64). Three weeks later, docetaxel...
Eligibility Criteria
Inclusion
- Written informed consent.
- Patients with breast cancer stages II and IIIA, with histological diagnoses as per true-cut or open biopsy.
- Negative extension study, including bilateral mammography, thoracic x-ray, computed tomography (CT)-scan or abdominal echography and bone scintigraphy.
- Analysis of hormone receptor status in primary tumour. It is highly recommended to obtain a tumour tissue sample before start of treatment, and after definitive surgery. These samples will be analysed centrally by Spanish Breast Cancer Research Group (GEICAM).
- Age \>= 18 and \<= 70 years old.
- Performance status as per Karnofsky index \>= 80.
- Minimum life expectancy of 6 months.
- Electrocardiogram (EKG) 12 weeks before registration to the study. If abnormalities are suspected, cardiac function must be assessed by left ventricular ejection fraction (LVEF).
- Haematology: neutrophils \>= 2.0 x10\^9/l; platelets \>= 100 x10\^9/l; hemoglobin \>=10 g/dl.
- Hepatic function: total bilirubin \<= 1 x upper normal limit (UNL); Aspartate aminotransferase (AST) (SGOT) and and Alanine aminotransferase (ALT) (SGPT) \<= 2.5 x UNL; alkaline phosphatase \<= 5 x UNL.
- Renal function: creatinine \<= 1.5 x UNL; creatinine clearance \>= 60 ml/min.
- Patients able to comply with study requirements.
- Negative pregnancy test.
- Adequate contraceptive method during the study and up to 3 months after definitive surgery.
Exclusion
- Previous systemic therapy for breast cancer treatment.
- Previous treatments with anthracyclines or taxanes for any malignancy.
- Previous radiotherapy for breast cancer.
- Bilateral invasive breast cancer.
- Pregnant or lactating women.
- Previous motor or sensorial neurotoxicity grade \>=2.
- Other serious pathologies: congestive heart failure or angina pectoris; history of myocardial infarction in the previous year; uncontrolled hypertension (HT) or high risk arrhythmias.
- History of neurological or psychiatric impairment, precluding patients from providing free informed consent.
- Active infection.
- Active peptic ulcer; unstable diabetes mellitus.
- History of previous or current malignancies other than breast cancer, except for basal skin carcinoma, cervical in situ carcinoma, other tumour diagnosed and treated more than 10 years before, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS).
- Chronic treatment with corticoids unless the treatment started \> 6 months before registration to the study, and low doses are administered.
- Substitutive hormonal therapy. This treatment must be interrupted before inclusion in the study.
- Concomitant treatment with other investigational products or administration in the 30 previous days.
- Males.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00129376
Start Date
February 1 2003
End Date
February 1 2010
Last Update
July 5 2019
Active Locations (6)
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1
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, Spain, 08208
3
Hospital de la Ribera
Alzira, Valencia, Spain, 46600
4
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain, 15006