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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

636 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2020-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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5-Fu/epirubicin/CTX following Docetaxel

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

Group Type ACTIVE_COMPARATOR

5-Fu/epirubicin/CTX following Docetaxel

Intervention Type 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)

Docetaxel/capecitabine followed by XEC

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

Group Type EXPERIMENTAL

Docetaxel/capecitabine followed by XEC

Intervention Type 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)

Interventions

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5-Fu/epirubicin/CTX following Docetaxel

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)

Intervention Type DRUG

Docetaxel/capecitabine followed by XEC

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)

Intervention Type DRUG

Other Intervention Names

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Fluorouracil: 5-Fu Capecitabine: Xeloda

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Zhimin Shao, MD

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhimin Shao, M.D.

Role: PRINCIPAL_INVESTIGATOR

China Breast Cancer Clinical Study Group

Locations

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Pekingn Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

PLA 307 Hospital

Beijing, Beijing Municipality, China

Site Status

The General Hospital of the People's Liberation Army

Beijing, Beijing Municipality, China

Site Status

The First Affi liated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

South West Hospital

Chongqing, Chongqing Municipality, China

Site Status

Gansu Cancer Hospital

Lanzhou, Gansu, China

Site Status

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Site Status

Second Affiliated Hospital of Zhongshan University

Guangzhou, Guangdong, China

Site Status

Cancer Hospital of Shantou Medical College

Shantou, Guangdong, China

Site Status

Affiliated Hospital of Guiyang Medical College

Guiyang, Guizhou, China

Site Status

The Fourth Clinical Medical College of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

The second affiliated hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

The third affiliated hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

Henan cancer hospital affiliated to Zhengzhou university

Zhengzhou, Henan, China

Site Status

Hubei General Hospital

Wuhan, Hubei, China

Site Status

Xiangya Hospital Central-south University

Changsha, Hunan, China

Site Status

Jiangsu Cancer Hospital

Suzhou, Jiangsu, China

Site Status

Jiangsu Province Hospital

Suzhou, Jiangsu, China

Site Status

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

Third Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status

Jinlin Cancer Hospital & Institute

Changchun, Jilin, China

Site Status

The First Hospital of Jilin University

Changchun, Jilin, China

Site Status