Overview

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

Status:
Completed
Trial end date:
2016-04-20
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fudan University
Collaborator:
Chinese Anti-Cancer Association
Treatments:
Cisplatin
Cyclophosphamide
Docetaxel
Epirubicin
Fluorouracil
Paclitaxel
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.