Comparison Study of Adjuvant Chemotherapy for Chinese Triple Negative Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Fudan University.
Recruitment status was  Available
Sponsor:
Collaborator:
Chinese Anti-Cancer Association
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01216111
First received: October 6, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted

October 6, 2010
October 6, 2010
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Comparison Study of Adjuvant Chemotherapy for Chinese Triple Negative Breast Cancer
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

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 Female adults(>18 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 >8.0g/dL, and platelet count >100,000/mm3,creatinine<2.5 times the upper limit of normal(ULN)), transaminases<2.5 times ULN or alkaline phosphatase<4 times ULN if transaminases was normal, and total bilirubin <2.5 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)

Expanded Access
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Triple Negative Breast Cancer
Drug: Paclitaxel Cisplatin

Paclitaxel 100 mg/m2 D1,8,15 Cisplatin AUC=2 D1,8,15

1 cycle = 28days

PC*6

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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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Inclusion Criteria:

  1. Women aged from 18 to 65 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. Node positive disease (positive sentinel node or positive axillary clearance) (N+) or node negative disease (N-) with the following criteria : SBR II / III and pT > 5 mm;
  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<10%, PR<10% (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 £ 1.5 ULN alkaline phosphatases £ 2.5 ULN,total bilirubin £ 1,5 ULN;
  14. Adequate renal function: serum creatinine £ 1.5 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 tumor ³ T4a (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.
Female
18 Years to 65 Years
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Contact: Zhimin Shao, MD, PHD +862164175590 ext 8708 luona801379@hotmail.com
Contact: Fei Fei, MD +862164175590 ext 8700 baketutu520@gmail.com
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NCT01216111
Fudan TNBC Adjuvant CT
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Chinese Anti-Cancer Association,Committee Breast Cancer Society
Fudan University
Chinese Anti-Cancer Association
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Fudan University
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP