Comparative Study on Two Post-operative Adjuvant Chemotherapy Regimens for Treating Triple-negative Breast Cancer

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

Recent clinical studies showed that triple-negative breast cancer patients (ER-/PR-/HER2-) may benefit more from Capecitabine chemotherapy. However, the optimum post-operative adjuvant Capecitabine chemotherapy regimen has not been determined for Chinese population with triple-negative breast cancer. Thus it's necessary to conduct a multi-center Phase III clinical trial to verify efficacy and safety of Capecitabine in the treatment of triple-negative breast cancer. In this study, a prospective, randomized, open, multi-center Phase III clinical study was conducted 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Breast Cancer Clinical Study Group
• Treatments: Capecitabine; Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil; Polystyrene sulfonic acid

Criteria

Inclusion Criteria:

• Female aged 18 - 70 years old;

• Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable);

• 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 therapy;

• 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.