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

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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

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Abraxane Drug: Epirubicin Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 Epirubicin regimen or any ingredient of Abraxane or Epirubicin.
  8. Any severe systemic disease contraindicating chemotherapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647280


Contacts
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Contact: Ding Xiaowen, DR. +86 13588054604 dingxw@zjcc.org.cn
Contact: Ding Yuqin +86 13588255651 13588255651@163.com

Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
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Principal Investigator: Ding Xiaowen, DR. Zhejiang Cancer Hospital

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Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT03647280     History of Changes
Other Study ID Numbers: dingxwyh02
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhejiang Cancer Hospital:
Neoadjuvant Chemotherapy
Abraxane
Epirubicin

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Epirubicin
Albumin-Bound Paclitaxel
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators