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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

18 Years
65 Years
Open (Enrolling)
Triple Negative Breast Cancer

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Trial Information

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

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)

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

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

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

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

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

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

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

8. Patients already included in another therapeutic trial involving an experimental

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

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

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

Type of Study:

Expanded Access

Study Design:



United States: Food and Drug Administration

Study ID:

Fudan TNBC Adjuvant CT



Start Date:

Completion Date:

Related Keywords:

  • Triple Negative Breast Cancer
  • triple negative breast cancer,local recurrence,distant metastasis
  • Breast Neoplasms