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

Last updated: May 17, 2020
Sponsor: Fudan University
Overall Status: Completed

Phase

3

Condition

Breast Cancer

Treatment

N/A

Clinical Study ID

NCT01216111
Fudan TNBC Adjuvant CT
  • Ages 18-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 initialsurgery;

  6. positive lymph node or negative lymph node with tumor size > 1.0cm

  7. Patient presenting one of the following criteria (reviewed before randomization byreferent 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 thetime of a minor surgery (excluding breast biopsy); at least three weeks for majorsurgery);

  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,totalbilirubin ≤ 1,5 ULN;

  14. Adequate renal function: serum creatinine ≤ 1 ULN;

  15. Patients accepting contraception intake during the overall length of treatment if ofchildbearing potential;

  16. Adequate cardiac function, LEVF value > 50% by Muga scan or echocardiography;

  17. Signed written informed consent.

Exclusion

Exclusion Criteria:

  1. Bilateral breast cancer or patient with controlateral DCIS;

  2. Any metastatic impairment, including homolateral sub-clavicular nodeinvolvement,regardless of its type;

  3. Any T4 lesion (UICC1987) (cutaneous invasion, deep adherence, inflammatory breastcancer);

  4. ER+ or PR+ or Her-2 overexpression

  5. Any clinically or radiologically suspect and non-explored damage to the controlateralbreast;

  6. Any chemotherapy, hormonal therapy or radiotherapy before surgery;

  7. Previous cancer (excepted cutaneous baso-cellular epithelioma or uterin peripheralephitelioma) 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 infectionwhich could compromise participation in the study;

  10. LEVF < 50% (MUGA scan or echocardiography);

  11. Clinically significant cardiovascular disease (e.g. unstable angina, congestive heartfailure, uncontrolled hypertension (>150/90), myocardial infarction or cerebralvascular 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 acceptablemethod to avoid pregnancy for the entire study period and up to 8 weeks aftertreatment completion;

  14. Women who are pregnant or breastfeeding. Adequate birth control measures should betaken during study treatment phase;

  15. Women with a positive pregnancy test en enrollment or prior to study drugadministration;

  16. Patients with any psychological, familial, sociological or geographical conditionpotentially hampering compliance with the study protocol and follow-up schedule; thoseconditions should be discussed with the patient before registration in the trial;

  17. Individual deprived of liberty or placed under the authority of a tutor.

Study Design

Total Participants: 647
Study Start date:
January 01, 2011
Estimated Completion Date:
April 20, 2016

Study 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