Marched Pair Study Conventional Doxorubicin(DOX) Versus Pegylated Liposomal Doxorubicin(PLD) Neoadjuvant Chemotherapy

• Status: Unknown status
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The regimen PLD plus cyclophosphamide 4 cycles followed by paclitaxel or docetaxel 4 cycles(noted in phase II CAPRICE) will be used as experimental group. The regimen will be compared to the standard treatment of doxorubicin plus cyclophosphamide(AC) 4 cycles followed by paclitaxel or docetaxel 4 cycles[noted in National Comprehensive Cancer Network (NCCN) guideline].

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jilin University
• Treatments: Cyclophosphamide; Dexrazoxane; Docetaxel; Doxorubicin; Liposomal doxorubicin; Pirarubicin; Razoxane; Vitamin B Complex; Vitamins

Criteria

Inclusion Criteria:

• Patient with histological proof of invasive cancer, whose clinical tumor diameter is > 2 cm, or < 2 cm, but Axillary lymphnodes are involved .There is no metastatic Imaging findings.

• Stage II,III tumor, non-metastatic, grade II - III

• Performance Status = 0-1 World Health Organization (WHO).

• Patient non pretreated for breast cancer.

• Patient without cardiac pathology and without anthracyclines contra-indication (assessed by normal ejection fraction).

• Normal haematological, renal and hepatic functions : platelets > 100. 109 /l, Hb > 10 g/dl, normal bilirubin serum , Aspartate transaminase(ASAT) and Alanine Aminotransferase(ALAT) < 2,5 Upper Limit of Normal (ULN), alkaline phosphatases < 2,5 ULN, creatinin < 140 µmol/l or creatinin clearance > 60 ml/min

• Written informed consent dated and signed by the patient

Exclusion Criteria:

• All other breast cancers than those described in inclusion criteria, in particular inflammatory and/or neglected (T4b or T4d) forms.

• Patient presenting with intraduct cancer in situ.(DCIS)

• Grade I well differentiated tumor.

• Non measurable lesion, in the two diameters, whatever radiological methods used.

• Patient already operated for breast cancer or having had primary axillar node dissection.

• Patient presenting with cancer in other system.

• Any psychological, familial, sociological or geographical condition that may potentially hamper compliance with the study protocol and follow up schedule, assessed with the patient prior to registration in the trial