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

NCT01642771 | Unknown Phase 3 DMC

• 1 other identifier: EBC protocol 1.1
• Study Type: interventional
• Target: 636
• Locations: 1 country
• Sites: 37

Brief 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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 5-year disease free survival

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

  5 year after the completion of chemotherapy

Secondary Outcomes (5)

• Number of Participants with Adverse Events as a Measure of Safety

  Within 5 years after the completion of chemotherapy

• FACT-B scale scores as a Measure of living quality

  Baseline, Week 0

• 5-year relapse free survival, distant disease free survival and overall survival as measures of efficacy

  Within 5 years after the completion of chemotherapy

• FACT-B scale scores as a Measure of living quality

  Week 9

• FACT-B scale scores as a Measure of living quality

  Week 18

Study Arms (2)

5-Fu/epirubicin/CTX following Docetaxel

ACTIVE COMPARATOR

Docetaxel for the first 3 cycles of chemotherapy followed by 3 cycles of FEC (Fluorouracil, epirubicin and cyclophosphamide) chemotherapy

Drug: 5-Fu/epirubicin/CTX following Docetaxel

Docetaxel/capecitabine followed by XEC

EXPERIMENTAL

Docetaxel/ capecitabine (TX) for the first 3 cycles of chemotherapy followed by 3 cycles of capecitabine/epirubicin/cyclophosphamide (XEC) chemotherapy

Drug: Docetaxel/capecitabine followed by XEC

Interventions

5-Fu/epirubicin/CTX following Docetaxel DRUG

Cycle 1-3: Docetaxel i.v. 75mg/m2 (One cycle = 21 days); Cycle 4-6: Fluorouracil i.v. 500 mg/m2, Epirubicin i.v. 75 mg/m2, Cyclophosphamide i.v. 500 mg/m2 (One cycle = 21 days)

Also known as: Fluorouracil: 5-Fu

5-Fu/epirubicin/CTX following Docetaxel

Docetaxel/capecitabine followed by XEC DRUG

Cycle 1-3: Docetaxel i.v. 75 mg/m2, Capecitabine, p.o., 1000 mg/m2，b.i.d (take Capecitabine for 2 weeks and withdraw for 1 week) (One cycle = 21 days); Cycle 4-6: Capecitabine, i.v. 1000 mg/m2, b.i.d (take for 2 weeks and withdraw for 1 week),Epirubicin, i.v. 75 mg/m2, Cyclophosphamide, i.v. 500 mg/m2 (One cycle = 21 days)

Also known as: Capecitabine: Xeloda

Docetaxel/capecitabine followed by XEC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• China Breast Cancer Clinical Study Group: lead

Study Sites (37)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Pekingn Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

PLA 307 Hospital

Beijing, Beijing Municipality, 100071, China

Location

The General Hospital of the People's Liberation Army

Beijing, Beijing Municipality, 100853, China

Location

The First Affi liated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

South West Hospital

Chongqing, Chongqing Municipality, 400038, China

Location

Gansu Cancer Hospital

Lanzhou, Gansu, 730050, China

Location

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

Second Affiliated Hospital of Zhongshan University

Guangzhou, Guangdong, 510120, China

Location

Cancer Hospital of Shantou Medical College

Shantou, Guangdong, 515041, China

Location

Affiliated Hospital of Guiyang Medical College

Guiyang, Guizhou, 550002, China

Location

The Fourth Clinical Medical College of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location

The second affiliated hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

The third affiliated hospital of Harbin Medical University

Harbin, Heilongjiang, 150040, China

Location

Henan cancer hospital affiliated to Zhengzhou university

Zhengzhou, Henan, 450008, China

Location

Hubei General Hospital

Wuhan, Hubei, 430070, China

Location

Xiangya Hospital Central-south University

Changsha, Hunan, 410008, China

Location

Jiangsu Cancer Hospital

Suzhou, Jiangsu, 210000, China

Location

Jiangsu Province Hospital

Suzhou, Jiangsu, 210029, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location

Third Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330009, China

Location

Jinlin Cancer Hospital & Institute

Changchun, Jilin, 130012, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai 6th People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, 200433, China

Location

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030013, China

Location

Second Affiliated Hospital of Medical College of Xi'An Jiaotong University

Xi’an, Shanxi, 710004, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Xinjiang Cancer Hospital

Ürümqi, Xinjiang, 830000, China

Location

Zhejiang First Hospital

Hangzhou, Zhejiang, 310003, China

Location

Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

The First Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

Location

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MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Docetaxel; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Zhimin Shao, M.D.

  China Breast Cancer Clinical Study Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 4, 2012
• First Posted: July 17, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: May 1, 2020
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

CN (37)