Üçlü Negatif Meme Kanserinde Ameliyat Sonrası Platin ve Taksan (PATTERN)

Sade dilde özet

Bu çalışma, üçlü negatif meme kanseri (triple-negative breast cancer) olan kadınlarda ameliyat sonrası (adjuvan) Paklitaksel + Sisplatin tedavisini, standart FEC-T kemoterapisiyle karşılaştırıyor. Ameliyatla tümörü tamamen çıkarılmış, 18-70 yaş arası kadınlar dahil edilmiştir. Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Tamamlandı

Sponsor

Fudan University

Müdahale

Paclitaxel Cisplatin, fluorouracil epirubicin cyclophosphamide and docetaxel (FEC-T)

Başlangıç

01.01.2011

Tahmini bitiş

20.04.2016

İlgili genler

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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.