Abraxane Combined With Xeloda as Neo-Adjuvant Chemotherapy in Early Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Abraxane
Xeloda
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring neoadjuvant chemotherapy, Abraxane, Xeloda
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent
- Women and men at least 18 years of age or older.
- Pathological confirmation of breast cancer
- Tumor stage(TNM):T2-4N0-3M0
- No evidence of distant metastasis
- Adequate bone marrow, hepatic, and renal function
- Measurable disease as per RECIST criteria
- Karnofsky≥70
- Laboratory criteria:
PLT≥100*109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST<2*ULN
Exclusion Criteria:
- Presence of metastatic disease.
- Inflammatory breast cancer.
- Bilateral breast cancer.
- previous chemotherapy or hormonal therapy for current breast neoplasm.
- other malignant tumors (concurrent or previous).
- Pregnant woman.
- Hypersensitive to any drug in Abraxane or Xeloda regimen or any ingredient of Abraxane or Xeloda.
- Any severe systemic disease contraindicating chemotherapy
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Abraxane Combined With Xeloda
Arm Description
Tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
Outcomes
Primary Outcome Measures
ORR(CR+PR)
To evaluate the efficacy of concurrent Abraxane and Xeloda 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
Side Effects.
Determine side effects of these drugs like cardiotoxicity ,hematological toxicity,gastrointestinal symptoms and so on.
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.
Overall Survival(OS)
Time from the first dose of Abraxane and Xeloda to death due to any cause
Full Information
NCT ID
NCT03647514
First Posted
June 10, 2018
Last Updated
December 6, 2018
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03647514
Brief Title
Abraxane Combined With Xeloda as Neo-Adjuvant Chemotherapy in Early Breast Cancer
Official Title
A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Abraxane Combined With Xeloda as Neo-Adjuvant Chemotherapy in Early Operable Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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.
Detailed Description
The hypothesis is that tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
neoadjuvant chemotherapy, Abraxane, Xeloda
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Abraxane Combined With Xeloda
Arm Type
Experimental
Arm Description
Tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
Intervention Type
Drug
Intervention Name(s)
Abraxane
Intervention Description
Tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
Intervention Type
Drug
Intervention Name(s)
Xeloda
Intervention Description
Tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
Primary Outcome Measure Information:
Title
ORR(CR+PR)
Description
To evaluate the efficacy of concurrent Abraxane and Xeloda 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).
Time Frame
Following the completion of 12 weeks of neoadjuvant chemotherapy Treatment
Secondary Outcome Measure Information:
Title
Side Effects.
Description
Determine side effects of these drugs like cardiotoxicity ,hematological toxicity,gastrointestinal symptoms and so on.
Time Frame
First Dose of Abraxane and Xeloda up to 24 months
Title
Event Free Survival(DFS)
Description
Time of surgery to first documentation of local or distant recurrence, or death or initiation of antineoplastic therapy before documentation of first relapse.
Time Frame
Time of Surgery up to 5 years
Title
Overall Survival(OS)
Description
Time from the first dose of Abraxane and Xeloda to death due to any cause
Time Frame
First Dose of Abraxane and Xeloda up to 5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent
Women and men at least 18 years of age or older.
Pathological confirmation of breast cancer
Tumor stage(TNM):T2-4N0-3M0
No evidence of distant metastasis
Adequate bone marrow, hepatic, and renal function
Measurable disease as per RECIST criteria
Karnofsky≥70
Laboratory criteria:
PLT≥100*109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST<2*ULN
Exclusion Criteria:
Presence of metastatic disease.
Inflammatory breast cancer.
Bilateral breast cancer.
previous chemotherapy or hormonal therapy for current breast neoplasm.
other malignant tumors (concurrent or previous).
Pregnant woman.
Hypersensitive to any drug in Abraxane or Xeloda regimen or any ingredient of Abraxane or Xeloda.
Any severe systemic disease contraindicating chemotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ding Xiaowen, Doc
Phone
+86 13588054604
Email
dingxw@zjcc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ding Yuqin
Phone
+86 13588255651
Email
13588255651@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ding Xiaowen, Doc
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Abraxane Combined With Xeloda as Neo-Adjuvant Chemotherapy in Early Breast Cancer
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