Abraxane Combined With Xeloda as Neo-Adjuvant Chemotherapy in Early Breast Cancer

• Status: Unknown status
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: Female

Summary

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 Xeloda (1250mg/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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Albumin-Bound Paclitaxel; Capecitabine; Paclitaxel

Criteria

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 Xeloda regimen or any ingredient of Abraxane or Xeloda.

8. Any severe systemic disease contraindicating chemotherapy