Breast Cancer Clinical Trial
Official title:
A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Abraxane Combined With Epirubicin as Neoadjuvant Chemotherapy in Early Operable Breast Cancer
Some studies have demonstrated the efficacy of Abraxane in treating breast cancer in both
adjuvant and metastatic settings. Few data is available on Abraxane in neoadjuvant treatment
for breast cancer.
The aim of this project is to evaluate tailored primary systemic therapy with weekly Abraxane
(125mg/m2) Combined With Q3week Epirubicin (100mg/m2) in early operable (stage of T2-4N0-3M0)
breast cancer. This study will be an open label non randomized, single arm, single center
study.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | September 30, 2020 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Provision of informed consent 2. Women and men at least 18 years of age or older. 3. Pathological confirmation of breast cancer 4. Tumor stage(TNM): T2-4N0-3M0 5. No evidence of distant metastasis 6. Adequate bone marrow, hepatic, and renal function 7. Measurable disease as per RECIST criteria 8. Karnofsky=70 9. Laboratory criteria: PLT=100*109/L WBC=4000/mm3 HGB=10g/dl ALT and AST<2*ULN Exclusion Criteria: 1. Presence of metastatic disease. 2. Inflammatory breast cancer. 3. Bilateral breast cancer. 4. previous chemotherapy or hormonal therapy for current breast neoplasm. 5. other malignant tumors (concurrent or previous). 6. Pregnant woman. 7. Hypersensitive to any drug in Abraxane or Epirubicin regimen or any ingredient of Abraxane or Epirubicin. 8. Any severe systemic disease contraindicating chemotherapy. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Zhejiang Cancer Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ORR(CR+PR) | To evaluate the efficacy of concurrent Abraxane and Epirubicin as neoadjuvant regimen in terms of: ORR(CR+PR), downstaging rates in tumor size and axillary lymph node. Pathological Complete Response(pCR) defined by: defined as ypT0, ypN0 (the absence of residual invasive and in situ cancer on evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy). |
Following the completion of 12 weeks of neoadjuvant chemotherapy Treatment. | |
Secondary | Side Effects. | Determine side effects of these drugs like cardiotoxicity ,hematological toxicity,gastrointestinal symptoms and so on. | First Dose of Abraxane and Epirubicin up to 24 months. | |
Secondary | Event Free Survival(DFS) | Time of surgery to first documentation of local or distant recurrence, or death or initiation of antineoplastic therapy before documentation of first relapse. | Time of Surgery up to 5 years | |
Secondary | Overall Survival(OS) | Time from the first dose of Abraxane and Epirubicin to death due to any cause. | First Dose of Abraxane and Epirubicin up to 5 years. |
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