The Efficacy and Safety of Abraxane Combined With Epirubicin as Neoadjuvant Chemotherapy in Breast Cancer

Overview

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.

Full Title of Study: “A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Abraxane Combined With Epirubicin as Neoadjuvant Chemotherapy in Early Operable Breast Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2020

Detailed Description

The hypothesis is that tailored neoadjuvant chemotherapy with 4 cycles of PE(weekly Abraxane 125mg/m2, Q3week Epirubicin 100mg/m2, 21day/cycle) is feasible and achieves high response rates. It is proposed that 50 patients will be enrolled in this study. The target population is women with early breast cancer (stage of T2-4N0-3M0) who are eligible for primary systemic therapy. The primary objective of the trial is to determine the overall response rate. Secondary endpoints will include response rates in axillary lymph nodes, safety and tolerability and the rate of breast conservation.

Interventions

  • Drug: Abraxane
    • Tailored neoadjuvant chemotherapy with 4 cycles of PE(weekly Abraxane 125mg/m2, Q3week Epirubicin 100mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
  • Drug: Epirubicin
    • Tailored neoadjuvant chemotherapy with 4 cycles of PE(weekly Abraxane 125mg/m2, Q3week Epirubicin 100mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.

Arms, Groups and Cohorts

  • Experimental: Abraxane Combined With Epirubicin
    • Tailored neoadjuvant chemotherapy with 4 cycles of PE(weekly Abraxane 125mg/m2, Q3week Epirubicin 100mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.

Clinical Trial Outcome Measures

Primary Measures

  • ORR(CR+PR)
    • Time Frame: Following the completion of 12 weeks of neoadjuvant chemotherapy Treatment.
    • 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).

Secondary Measures

  • Side Effects.
    • Time Frame: First Dose of Abraxane and Epirubicin up to 24 months.
    • Determine side effects of these drugs like cardiotoxicity ,hematological toxicity,gastrointestinal symptoms and so on.
  • Event Free Survival(DFS)
    • Time Frame: Time of Surgery up to 5 years
    • Time of surgery to first documentation of local or distant recurrence, or death or initiation of antineoplastic therapy before documentation of first relapse.
  • Overall Survival(OS)
    • Time Frame: First Dose of Abraxane and Epirubicin up to 5 years.
    • Time from the first dose of Abraxane and Epirubicin to death due to any cause.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Zhejiang Cancer Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ding Xiaowen, DR., Principal Investigator, Zhejiang Cancer Hospital
  • Overall Contact(s)
    • Ding Xiaowen, DR., +86 13588054604, dingxw@zjcc.org.cn

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