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Adjuvant Platinum and Taxane in Triple-negative Breast Cancer (PATTERN)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01216111
Recruitment Status : Completed
First Posted : October 7, 2010
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
Chinese Anti-Cancer Association
Information provided by (Responsible Party):
Zhimin Shao, Fudan University

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 young age, advanced clinical stage, high histologic and nuclear grade and more distant recurrence.

According to the characteristics of triple negative breast tumor, the TNBC patients can benefit neither from hormonal therapies nor from target therapies against Her2 receptors. The only systemic therapy currently available is chemotherapy, and prognosis remains poor. It becomes more and more important to investigate the sensitive chemotherapy regimen for triple negative patients.

Cisplatin-based regimen was active for the patients of lung cancer, colorectal cancer and ect. Triple negative breast cancer patients were more sensitive to platinum-based chemotherapy regimens according to the results of some retrospective studies.

The investigators hypothesized that paclitaxel combined with cisplatin is more sensitive to triple negative breast cancer compared with CEF followed by docetaxel.


Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Drug: Paclitaxel Cisplatin Drug: fluorouracil epirubicin cyclophosphamide and docetaxel (FEC-T) Phase 3

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 or 1, absolute neutrophil count (ANC)>1500/mm3,hemoglobin >90g/dL, and platelet count >100,000/mm3,creatinine<2.5 times the upper limit of normal(ULN)), transaminases<3 times ULN or alkaline phosphatase<4 times ULN if transaminases was normal, and total bilirubin <1.5 times ULN. Exclusion criteria were active infection, pregnancy, other primary malignancy (except in situ carcinoma of cervix or adequately treated nonmelanomatous carcinoma of the skin), any documented distant metastasis and uncontrolled systemic diseases.

This study protocol was approved by institutional ethic review boards and conducted according to guidelines for good clinical practice and the Helsinki Declaration.All patients provided written informed consent.

Outcome Measures Primary Endpoint:5 year Disease Free Survival(DFS) Second Endpoints:5 year distant disease free survival (DDFS) 5 year event free survival (EFS) 5 year overall survival (OS) 5 year DFS in gBRCA1 mutation carriers and homologous recombination repair (HRR)-related gene mutation carriers

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 647 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open-label, Multicentric,phaseIII Clinical Trial Compared With PC and CEF100 Followed by Docetaxel as Adjuvant Chemotherapy Regimen for Chinese Primary Triple Negative Breast Cancer Patients
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : April 20, 2016
Actual Study Completion Date : April 20, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 6 cycles of PC adjuvant chemotherapy
paclitaxel 80 mg/m2 and carboplatin (area under the curve [AUC]= 2) on day 1, 8, 15 every 28 days for six cycles
Drug: Paclitaxel Cisplatin

Paclitaxel 80 mg/m2 D1,8,15 Cisplatin AUC=2 D1,8,15

1 cycle = 28days

PC*6


Active Comparator: 3 cycles of FEC followed by 3 cycles of Docetaxel
fluorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2 intravenously on day 1 every 21 days for three cycles followed by docetaxel 100 mg/m2 intravenously
Drug: fluorouracil epirubicin cyclophosphamide and docetaxel (FEC-T)
fluorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2 intravenously on day 1 every 21 days for three cycles followed by docetaxel 100 mg/m2 intravenously




Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 5 year ]
    time from random assignment to first relapse (local, regional and distant), contralateral breast cancer


Secondary Outcome Measures :
  1. distant disease-free survival [ Time Frame: 5 year ]
    time from random assignment to distant recurrence or death

  2. relapse-free survival [ Time Frame: 5 year ]
    time from the date of randomization to local, regional, distant relapse or death

  3. disease-free survival gBRCA1 mutation carriers and homologous recombination repair (HRR)-related gene mutation carriers [ Time Frame: 5 year ]
  4. overall survival [ Time Frame: 5 year ]
    time from randomization until death with any cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women aged from 18 to 70 years;
  2. Histologically proven invasive unilateral breast cancer (regardless of the type);
  3. Initial clinical condition compatible with complete initial resection;
  4. No residual macro or microscopic tumor after surgical excision;
  5. Beginning of chemotherapeutic treatment no later than day 42 after the initial surgery;
  6. positive lymph node or negative lymph node with tumor size > 1.0cm
  7. 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].

  8. No clinically or radiologically detectable metastases (M0);
  9. No peripheral neuropathy > 1;
  10. WHO Performance status (ECOG) of 0 or 1;
  11. 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);
  12. Adequate hematological function (neutrophil count ³ 2x109/l, platelet count ³ 100x 109/l, Hemoglobin > 9 g/dl);
  13. Adequate hepatic function: ASAT and ALAT ≤ 3 ULN alkaline phosphatases ≤ 2.5 ULN,total bilirubin ≤ 1,5 ULN;
  14. Adequate renal function: serum creatinine ≤ 1 ULN;
  15. Patients accepting contraception intake during the overall length of treatment if of childbearing potential;
  16. Adequate cardiac function, LEVF value > 50% by Muga scan or echocardiography;
  17. Signed written informed consent.

Exclusion Criteria:

  1. Bilateral breast cancer or patient with controlateral DCIS;
  2. Any metastatic impairment, including homolateral sub-clavicular node involvement,regardless of its type;
  3. Any T4 lesion (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer);
  4. ER+ or PR+ or Her-2 overexpression
  5. Any clinically or radiologically suspect and non-explored damage to the controlateral breast;
  6. Any chemotherapy, hormonal therapy or radiotherapy before surgery;
  7. Previous cancer (excepted cutaneous baso-cellular epithelioma or uterin peripheral ephitelioma) in the preceding 5 years, including invasive controlateral breast cancer;
  8. Patients already included in another therapeutic trial involving an experimental drug;
  9. Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study;
  10. LEVF < 50% (MUGA scan or echocardiography);
  11. 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;
  12. Known prior severe hypersensitivity reactions to agents containing Cremophor EL;
  13. 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;
  14. Women who are pregnant or breastfeeding. Adequate birth control measures should be taken during study treatment phase;
  15. Women with a positive pregnancy test en enrollment or prior to study drug administration;
  16. 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;
  17. Individual deprived of liberty or placed under the authority of a tutor.
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhimin Shao, professor, Fudan University
ClinicalTrials.gov Identifier: NCT01216111    
Other Study ID Numbers: Fudan TNBC Adjuvant CT
First Posted: October 7, 2010    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020

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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 Zhimin Shao, Fudan University:
triple negative breast cancer,local recurrence,distant metastasis
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Cyclophosphamide
Fluorouracil
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antimetabolites
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors