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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03647280
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

Tracking Information
First Submitted Date  ICMJE June 10, 2018
First Posted Date  ICMJE August 27, 2018
Last Update Posted Date December 7, 2018
Estimated Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of Abraxane Combined With Epirubicin as Neoadjuvant Chemotherapy in Breast Cancer
Official Title  ICMJE A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Abraxane Combined With Epirubicin as Neoadjuvant Chemotherapy in Early Operable Breast Cancer
Brief 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 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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Drug: Abraxane
  • Drug: Epirubicin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ding Xiaowen, DR. +86 13588054604 dingxw@zjcc.org.cn
Contact: Ding Yuqin +86 13588255651 13588255651@163.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03647280
Other Study ID Numbers  ICMJE dingxwyh02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zhejiang Cancer Hospital
Study Sponsor  ICMJE Zhejiang Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ding Xiaowen, DR. Zhejiang Cancer Hospital
PRS Account Zhejiang Cancer Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP