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A Prospective, Randomized, Open, Multi-center Phase III Clinical Study Comparing Efficacy and Safety of Sequential T-FEC and TX-XEC as Post-operative Adjuvant Chemotherapy Options for the Treatment of Triple-negative Breast Cancer

Phase 3
18 Years
70 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Prospective, Randomized, Open, Multi-center Phase III Clinical Study Comparing Efficacy and Safety of Sequential T-FEC and TX-XEC as Post-operative Adjuvant Chemotherapy Options for the Treatment of Triple-negative Breast Cancer

Post-operative adjuvant chemotherapy has been shown to improve overall survival, delay local
relapse and reduce distant metastasis by multiple large-scale prospective clinical trial. In
registry clinical trial for Capecitabine conducted by O Shaughnessy, it revealed that a
combined chemotherapy of Capecitabine and Docetaxel achieved better outcomes compared with
Docetaxel alone. And the significant effect of Capecitabine was also evidenced by CHAT trial
in which Trastuzumab/Docetaxel/Capecitabine regimen was proved to perform greater than
Trastuzumab/Docetaxel regimen. In addition to better outcomes, Capecitabine also showed good
tolerance and safety profile. In 2009, Finnish Breast Cancer Group published their study
results from FinXX clinical trial on Lancet Oncology, and in this trial, they compared the
efficacy between sequential Docetaxel (3 cycles) followed by 3 cycles of
Fluorouracil/Epirubicin/Cyclophosphamide (FEC) and sequential Docetaxel and Capecitabine (3
cycles) followed by 3 cycles of Capecitabine/Epirubicin/Cyclophosphamide (XEC) in lymph
positive or high-risk lymph negative early-stage breast cancer patients. And their results
showed a better outcome in TX-XEC regimen. 5-year follow-up analysis of this trial revealed
that combined Capecitabine regimen can bring more significant clinical benefits to
triple-negative breast cancer patients. Another clinical trial NO1062 released their
preliminary results on comparison of AC-T and AC-XT regimens and it showed that combined
Capecitabine regimen can significantly improve overall survival and this effect is more
obvious in triple--negative breast cancer patients.

Based on the results of FinXX and NO1062, it's of great value to optimize combined
Capecitabine regimen and clarify involved questions, such as whether the efficacy of
Capecitabine is related to its treatment course or not, whether Capecitabine should be
combined into current standardized chemotherapy or a sequential therapy. Also, there are
still no clear conclusions on the best post-operative adjuvant chemotherapy for
triple--negative breast cancer patients. Especially in Chinese population, the efficacy and
safety of Capecitabine in adjuvant chemotherapy has not been well established. So it's
necessary to explore reasonable dosage, safety profile and efficacy of combined Capecitabine
therapy. Based on this purpose, this study is hoped to compare efficacy and safety of
sequential Docetaxel followed by Fluorouracil/Epirubicin/Cyclophosphamide (FEC) and
sequential Docetaxel and Capecitabine followed by Capecitabine/Epirubicin/Cyclophosphamide
(XEC) as post-operative adjuvant chemotherapy in the treatment of triple-negative breast
cancer in Chinese population.

Inclusion Criteria:

- Female aged 18 - 70 years old;

- Histological confirmed with unilateral invasive carcinoma (all pathological types are

- Newly diagnosed conditions allowing direct surgery without any absolute
contraindication for surgery;

- No mass or microscopic tumor residue after surgery resection;

- Initiate adjuvant chemotherapy within 30 days after surgery;

- Axillary lymph node positive (including the sentinel lymph node positive and lymph
node positive after axillary dissection), for example, axillary lymph node negative
requires that primary tumor size must be greater than 1cm;

- Definite reports on ER/PR/Her2 receptor showing all ER/PR/Her2 negative (specific
definitions: immunohistochemical detection of ER <10% tumor cells is defined as ER
negative, PR <10% positive tumor cells is defined as PR-negative, Her2 is 0~1+ or 2+
but determined negative via FISH or CISH detected (no amplification) is defined as
Her2 negative);

- No relevant clinical or imaging evidence of metastasis showing in the preoperative
examination (M0);

- Without peripheral neuropathy;

- ECOG performance score is 0 or 1;

- Postoperative recovery was good and an interval of at least one week since the
surgery is necessary;

- White blood cell count> 4 × 10^9/l, neutrophil count> 2 × 10^9/l, platelet count> 100
× 10^9/l and hemoglobin 9g/dl);

- ASAT and ALAT <1.5 folds of the upper limit of normal values, alkaline phosphatase
<2.5 folds of the upper limit of normal values, total bilirubin <1.5 folds of the
upper limit of normal values;

- Serum creatinine <1.5 folds of the upper limit of normal value;

- Women at childbearing age should take contraception measures during treatment;

- Cardiac function: echocardiographic examination showed LEVF> 50%;

- Informed consent form signed. -

Exclusion Criteria:

- Bilateral breast cancer or carcinoma in situ (DCIS / LCIS);

- Metastasis at any location;

- Any tumor > T4a (UICC1987) (accompanied by skin involvement, lump adhesion and
fixation, inflammatory breast cancer);

- Any of ER, PR or Her-2 is positive;

- Contralateral breast clinically or radiologically suspected to be malignant but not
confirmed which needs a biopsy;

- Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone

- Previously suffering from malignant tumors (except for basal cell carcinoma and
cervical carcinoma in situ), including contralateral breast cancer;

- Already enrolled into other clinical trials;

- Severe systemic disease and/or uncontrollable infection, unable to be enrolled in
this study

- LEVF <50% (echocardiography);

- Suffering from severe cardiovascular and cerebrovascular diseases within six months
before the randomization (such as: unstable angina, chronic heart failure,
uncontrollable high blood pressure > 150/90mmHg, myocardial infarction or brain
vascular accident);

- Known allergic to taxane and anthracycline agents;

- Women at childbearing age refuse to take contraception measures during the treatment
and 8 weeks after completion of treatment;

- Pregnant and breast-feeding women;

- Pregnancy test showed positive results before drug administration after enrolling in
to the study;

- With mental illness and cognitive impairment, unable to understand trial protocol and
side effects and complete trial protocol and follow-ups (systematic evaluation is
required before recruiting into this study);

- Without personal freedom and independent civil capacity.

Type of Study:


Study Design:

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

Outcome Measure:

5-year disease free survival

Outcome Description:

Including local relapse, distant metastasis, contralateral breast cancer, second primary cancer or death from any cause

Outcome Time Frame:

5 year after the completion of chemotherapy

Safety Issue:


Principal Investigator

Zhimin Shao, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

China Breast Cancer Clinical Study Group


United States: Institutional Review Board

Study ID:

EBC protocol 1.1



Start Date:

June 2012

Completion Date:

May 2020

Related Keywords:

  • Breast Cancer
  • Triple-negative Breast Cancer
  • Post-operative adjuvant Chemotherapy
  • Docetaxel
  • Capecitabine
  • Epirubicin
  • Cyclophosphamide
  • Fluorouracil
  • Breast Neoplasms