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NCT01216111 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2020-05-19

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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.
healthy Volunteers
false
maximum Age
70 Years
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    paclitaxel 80 mg/m2 and carboplatin (area under the curve \[AUC\]= 2) on day 1, 8, 15 every 28 days for six cycles
    intervention Names
    1. Drug: Paclitaxel Cisplatin
    label
    6 cycles of PC adjuvant chemotherapy
    type
    EXPERIMENTAL
  2. description
    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
    intervention Names
    1. Drug: fluorouracil epirubicin cyclophosphamide and docetaxel (FEC-T)
    label
    3 cycles of FEC followed by 3 cycles of Docetaxel
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. 6 cycles of PC adjuvant chemotherapy
    description
    Paclitaxel 80 mg/m2 D1，8，15 Cisplatin AUC=2 D1，8，15 1 cycle = 28days PC\*6
    name
    Paclitaxel Cisplatin
    type
    DRUG
  2. arm Group Labels
    1. 3 cycles of FEC followed by 3 cycles of Docetaxel
    description
    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
    name
    fluorouracil epirubicin cyclophosphamide and docetaxel (FEC-T)
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
647
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    time from random assignment to first relapse (local, regional and distant), contralateral breast cancer
    measure
    disease-free survival
    time Frame
    5 year
secondary Outcomes
  1. description
    time from random assignment to distant recurrence or death
    measure
    distant disease-free survival
    time Frame
    5 year
  2. description
    time from the date of randomization to local, regional, distant relapse or death
    measure
    relapse-free survival
    time Frame
    5 year
  3. measure
    disease-free survival gBRCA1 mutation carriers and homologous recombination repair (HRR)-related gene mutation carriers
    time Frame
    5 year
  4. description
    time from randomization until death with any cause
    measure
    overall survival
    time Frame
    5 year
Full study description
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.
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
Source references
references
  1. citation
    Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, Pollack JR, Ross DT, Johnsen H, Akslen LA, Fluge O, Pergamenschikov A, Williams C, Zhu SX, Lonning PE, Borresen-Dale AL, Brown PO, Botstein D. Molecular portraits of human breast tumours. Nature. 2000 Aug 17;406(6797):747-52. doi: 10.1038/35021093.
    pmid
    10963602
    type
    BACKGROUND
  2. citation
    Carey LA, Dees EC, Sawyer L, Gatti L, Moore DT, Collichio F, Ollila DW, Sartor CI, Graham ML, Perou CM. The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes. Clin Cancer Res. 2007 Apr 15;13(8):2329-34. doi: 10.1158/1078-0432.CCR-06-1109.
    pmid
    17438091
    type
    BACKGROUND
  3. citation
    Yehiely F, Moyano JV, Evans JR, Nielsen TO, Cryns VL. Deconstructing the molecular portrait of basal-like breast cancer. Trends Mol Med. 2006 Nov;12(11):537-44. doi: 10.1016/j.molmed.2006.09.004. Epub 2006 Sep 29.
    pmid
    17011236
    type
    BACKGROUND
  4. citation
    Reis-Filho JS, Tutt AN. Triple negative tumours: a critical review. Histopathology. 2008 Jan;52(1):108-18. doi: 10.1111/j.1365-2559.2007.02889.x.
    pmid
    18171422
    type
    BACKGROUND
  5. citation
    Cleator S, Heller W, Coombes RC. Triple-negative breast cancer: therapeutic options. Lancet Oncol. 2007 Mar;8(3):235-44. doi: 10.1016/S1470-2045(07)70074-8.
    pmid
    17329194
    type
    BACKGROUND
  6. citation
    Dent R, Trudeau M, Pritchard KI, Hanna WM, Kahn HK, Sawka CA, Lickley LA, Rawlinson E, Sun P, Narod SA. Triple-negative breast cancer: clinical features and patterns of recurrence. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4429-34. doi: 10.1158/1078-0432.CCR-06-3045.
    pmid
    17671126
    type
    BACKGROUND
  7. citation
    Hayes DF, Ethier S, Lippman ME. New guidelines for reporting of tumor marker studies in breast cancer research and treatment: REMARK. Breast Cancer Res Treat. 2006 Nov;100(2):237-8. doi: 10.1007/s10549-006-9253-5. Epub 2006 Jun 14. No abstract available.
    pmid
    16773436
    type
    BACKGROUND
  8. citation
    Yu KD, Ye FG, He M, Fan L, Ma D, Mo M, Wu J, Liu GY, Di GH, Zeng XH, He PQ, Wu KJ, Hou YF, Wang J, Wang C, Zhuang ZG, Song CG, Lin XY, Toss A, Ricci F, Shen ZZ, Shao ZM. Effect of Adjuvant Paclitaxel and Carboplatin on Survival in Women With Triple-Negative Breast Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1390-1396. doi: 10.1001/jamaoncol.2020.2965.
    pmid
    32789480
    type
    DERIVED
Source notices and limitations
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        1;anthracycline-containing regimens):</p> <div class="pdq-content-list"><ol id="_3066"><li>The <a href="/clinicaltrials/NCT01216111">PATTERN</a> trial (NCT01216111) compared an anthracycline-based regimen (cyclophosphamide, 5-FU, epirubicin, and docetaxel [CEF-T]) with paclitaxel and carboplatin (PCb) in 647 Chinese women
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      1. context
        Updated: April 25, 2025
        datetime
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        April 25, 2025

    Preserved source evidence · Not medical advice