Status:
COMPLETED
Adjuvant Platinum and Taxane in Triple-negative Breast Cancer (PATTERN)
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Chinese Anti-Cancer Association
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
Previous studies in Western country show that triple-negative breast cancer has aggressive clinical and pathological features compared with non-triple negative breast cancer, including onset at a youn...
Detailed Description
Eligibility Female adults(18-70 years old) are eligible if they had histologically confirmed primary breast cancer. Patients also had Eastern Cooperative Oncology Group(ECOG) Performance status of 0 o...
Eligibility Criteria
Inclusion
- Women aged from 18 to 70 years;
- Histologically proven invasive unilateral breast cancer (regardless of the type);
- Initial clinical condition compatible with complete initial resection;
- No residual macro or microscopic tumor after surgical excision;
- Beginning of chemotherapeutic treatment no later than day 42 after the initial surgery;
- positive lymph node or negative lymph node with tumor size \> 1.0cm
- Patient presenting one of the following criteria (reviewed before randomization by referent pathologist):
- Triple negative （ER-PR-Her-2-） Hormone receptor negativity is defined as ER\<1%, PR\<1% (IHC), HER2 negativity is defined as IHC 0-1+, or \[IHC 2+ and FISH or CISH negative\].
- No clinically or radiologically detectable metastases (M0);
- No peripheral neuropathy \> 1;
- WHO Performance status (ECOG) of 0 or 1;
- Adequate recovery from recent surgery (at least one week must have elapsed from the time of a minor surgery (excluding breast biopsy); at least three weeks for major surgery);
- Adequate hematological function (neutrophil count ³ 2x109/l, platelet count ³ 100x 109/l, Hemoglobin \> 9 g/dl);
- Adequate hepatic function: ASAT and ALAT ≤ 3 ULN alkaline phosphatases ≤ 2.5 ULN,total bilirubin ≤ 1,5 ULN;
- Adequate renal function: serum creatinine ≤ 1 ULN;
- Patients accepting contraception intake during the overall length of treatment if of childbearing potential;
- Adequate cardiac function, LEVF value \> 50% by Muga scan or echocardiography;
- Signed written informed consent.
Exclusion
- Bilateral breast cancer or patient with controlateral DCIS;
- Any metastatic impairment, including homolateral sub-clavicular node involvement,regardless of its type;
- Any T4 lesion (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer);
- ER+ or PR+ or Her-2 overexpression
- Any clinically or radiologically suspect and non-explored damage to the controlateral breast;
- Any chemotherapy, hormonal therapy or radiotherapy before surgery;
- Previous cancer (excepted cutaneous baso-cellular epithelioma or uterin peripheral ephitelioma) in the preceding 5 years, including invasive controlateral breast cancer;
- Patients already included in another therapeutic trial involving an experimental drug;
- Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study;
- LEVF \< 50% (MUGA scan or echocardiography);
- Clinically significant cardiovascular disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension (\>150/90), myocardial infarction or cerebral vascular accidents) within 6 months prior to randomization;
- Known prior severe hypersensitivity reactions to agents containing Cremophor EL;
- Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 8 weeks after treatment completion;
- Women who are pregnant or breastfeeding. Adequate birth control measures should be taken during study treatment phase;
- Women with a positive pregnancy test en enrollment or prior to study drug administration;
- Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
- Individual deprived of liberty or placed under the authority of a tutor.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2016
Estimated Enrollment :
647 Patients enrolled
Trial Details
Trial ID
NCT01216111
Start Date
January 1 2011
End Date
April 20 2016
Last Update
May 19 2020
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