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A Randomized Prospective Open Multicentric Phase III Clinical Trial Compared TC, FEC100 Followed by Docetaxel and EC90 Followed by Paclitaxel as Adjuvant Chemotherapy for Chinese Primary Breast Cancer Patients

Phase 3
40 Years
65 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Randomized Prospective Open Multicentric Phase III Clinical Trial Compared TC, FEC100 Followed by Docetaxel and EC90 Followed by Paclitaxel as Adjuvant Chemotherapy for Chinese Primary 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) 5year event free survival (EFS) 5year overall survival

Inclusion Criteria:

1. Women aged from 40 to 65 years old;

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 > 20 mm;

7. Patient presenting one of the following criteria (reviewed before randomization by
referent pathologist):Luminal A, Luminal B,Her-2 overexpressed 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

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. Triple negative (ER-PR-Her-2-)

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 uterine peripheral
epithelioma) 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:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease Free Survival

Outcome Description:

Percentage of Participants without Disease Recurrence and Distance Metastasis after 5 years

Outcome Time Frame:

5 years

Safety Issue:



United States: Food and Drug Administration

Study ID:

Fudan BC Adjuvant CT1



Start Date:

June 2010

Completion Date:

December 2018

Related Keywords:

  • Breast Cancer
  • Luminal A
  • Luminal B
  • Her-2 overexpression
  • DFS
  • DDFS
  • OS
  • Breast Neoplasms