Paclitaxol Every 2 Week Versus Paclitaxol Every 1 Week in the Adjuvant Treatment of Breast Cancer (PATEN)
Primary Purpose
Breast Cancer, Paclitaxel, Epirubicin
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Age between 18-70 years female operable breast cancer patients
- Patients were required to register within 60 days from the final surgical procedure required to adequately treat the invasive primary tumor.
- women who had operable,histologically confirmed adenocarcinoma of the breast with a. histologically involved positive lymph nodes b. or histologic diagnosis for three negative patients; c. or lymph node negative, HER2 positive(if HER2 + +, FISH (fluorescence in situ hybridization method)/CISH tests confirmed HER2 amplification is positive),but unable or intolerant to herceptin combined chemotherapy.
- Karnofsky points greater than or equal to 70.
- Postmenopausal women or HCG test results were negative, Women of child-bearing potential willing to use effective contraception during the study.
- PATIENT CHARACTERISTICS:
Hematopoietic:
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal
- TBIL no greater than 1.5 times upper limit of normal
- AKP no greater than 2.5 times upper limit of normal
- AST no greater than 2.5 times upper limit of normal
- ALT no greater than 2.5 times upper limit of normal
Renal:
- Creatinine no greater than 1.5 times upper limit of normal
Cardiovascular:
- No history of myocardial infarction
- No congestive heart failure
- No significant ischemic or valvular heart disease
Other:
- No other prior invasive malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
- No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs (with Cremophor or polysorbate)
Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EC-P2
EC-P1
Arm Description
all patients first received 4 cycles of intravenous epirubicin and cyclophosphamide at 3-week intervals and were then intravenous paclitaxel 2-week intervals for 4 cycles.
all patients first received 4 cycles of intravenous epirubicin and cyclophosphamide at 3-week intervals and were then intravenous paclitaxel 1-week intervals for 12 cycles.
Outcomes
Primary Outcome Measures
disease-free survival
time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence, or contralateral breast cancer.
Secondary Outcome Measures
disease-free survival
time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence, or contralateral breast cancer.
overall survival
time from randomization to disease death with/without recurrence breast cancer.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01848197
Brief Title
Paclitaxol Every 2 Week Versus Paclitaxol Every 1 Week in the Adjuvant Treatment of Breast Cancer
Acronym
PATEN
Official Title
An Open, Randomized, Parallel-group, Multicenter Clinical Study to Evaluate Efficacy and Safety of Paclitaxel Every 2 Weeks Compared Weekly in Adjuvant Treatment of Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taizhou Hospital
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Adjuvant chemotherapy has been proven to reduce significantly the risk for relapse and death in women with operable breast cancer.In the North American Inter-Group factorial trial design (CALGB 9741) the concept of dosedense adjuvant chemotherapy was further tested in patients with node-positive breast cancer.Weekly paclitaxel after standard adjuvant chemotherapy with epirubicin and cyclophosphamide improves disease-free and overall survival in women with breast cancer.Investigators asked if dose-dense 2-week intertreatment intervals (supported by the use of granulocyte-colony stimulating factor) were better than the conventional inconvenient weekly intervals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Paclitaxel, Epirubicin, Cyclophosphamide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EC-P2
Arm Type
Experimental
Arm Description
all patients first received 4 cycles of intravenous epirubicin and cyclophosphamide at 3-week intervals and were then intravenous paclitaxel 2-week intervals for 4 cycles.
Arm Title
EC-P1
Arm Type
Active Comparator
Arm Description
all patients first received 4 cycles of intravenous epirubicin and cyclophosphamide at 3-week intervals and were then intravenous paclitaxel 1-week intervals for 12 cycles.
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Primary Outcome Measure Information:
Title
disease-free survival
Description
time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence, or contralateral breast cancer.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
disease-free survival
Description
time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence, or contralateral breast cancer.
Time Frame
5 years
Title
overall survival
Description
time from randomization to disease death with/without recurrence breast cancer.
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Explore the relationship between neuropathy and DFS and the related predictive biomarkers (RWDD3 and TECTA gene SNP etc)
Time Frame
3 years
Title
Explore predictive biomarker of neutropenia;
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18-70 years female operable breast cancer patients
Patients were required to register within 60 days from the final surgical procedure required to adequately treat the invasive primary tumor.
women who had operable,histologically confirmed adenocarcinoma of the breast with a. histologically involved positive lymph nodes b. or histologic diagnosis for three negative patients; c. or lymph node negative, HER2 positive(if HER2 + +, FISH (fluorescence in situ hybridization method)/CISH tests confirmed HER2 amplification is positive),but unable or intolerant to herceptin combined chemotherapy.
Karnofsky points greater than or equal to 70.
Postmenopausal women or HCG test results were negative, Women of child-bearing potential willing to use effective contraception during the study.
PATIENT CHARACTERISTICS:
Hematopoietic:
Neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
Bilirubin no greater than 1.5 times upper limit of normal
TBIL no greater than 1.5 times upper limit of normal
AKP no greater than 2.5 times upper limit of normal
AST no greater than 2.5 times upper limit of normal
ALT no greater than 2.5 times upper limit of normal
Renal:
Creatinine no greater than 1.5 times upper limit of normal
Cardiovascular:
No history of myocardial infarction
No congestive heart failure
No significant ischemic or valvular heart disease
Other:
No other prior invasive malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs (with Cremophor or polysorbate)
Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feilin Cao, MD
Organizational Affiliation
Zhejiang Taizhou hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Paclitaxol Every 2 Week Versus Paclitaxol Every 1 Week in the Adjuvant Treatment of Breast Cancer
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