Neoadjuvant Treatment of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Triple-Negative or Her2 Positive Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00912444
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief Summary
The purpose of this study is to compare the pathological complete response (pCR) rate in triple-negative or Her2 positive breast cancer patients treated with neoadjuvant docetaxel, anthracycline and cyclophosphamide (TAC) or docetaxel and cyclophosphamide (TC) regimen.
- Detailed Description
Breast cancer is the leading cause of cancer in women in China. Neoadjuvant chemotherapy for treatment of locally advanced breast cancer has become a standard therapy. Results from neoadjuvant trials have shown that pathological complete response (pCR) is an independent predictor of outcome. Docetaxel was introduced into clinical practice in the early 1990s and has demonstrated good activity in the adjuvant and metastatic settings. Both TC and TAC are effective regimens in the adjuvant setting. The most optimal regimen in the neoadjuvant treatment is however unknown. This is especially true in triple-negative or HER2 positive breast cancer. This study will evaluate the pCR rate of TAC and TC as neoadjuvant treatment for triple-negative or HER2 positive breast cancer.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 102
- Women aged ≥ 18 years and < 70 years
- Karnofsky performance status (KPS) ≥ 70
- At least one measurable disease according to the RECIST. histologically confirmed invasive breast cancer (excluding inflammatory breast cancer), T2N1 or locally advanced breast cancer (T3-4N0-3 or T0-4N2-3)
- Biopsy specimens are available for ER, PgR and Her2 detection, patients should be with triple negative or Her2 positive breast cancer, Her2 positivity is defined as FISH/CISH Her2 positive or IHC Her2 3+, Triple-negative disease defined as negativity for ER, PgR and Her2
- Adequate bone marrow function: Neutrophil ≥ 1.5*109/L; Hb ≥ 100g/L; PLT ≥ 100*109/L
- An estimated life expectancy of at least 12 months
- Willing to take biopsy before neoadjuvant chemotherapy and patients must be accessible for treatment and follow-up
- Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
- Written informed consent according to the GCP
- Prior systemic or loco-regional treatment of breast cancer, including chemotherapy
- Metastatic breast cancer
- With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
- Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
- inadequate liver function (bilirubin > 1.0 times upper normal limit [UNL] and ALT and/or AST> 1.5 UNL associated with alkaline phosphatase > 2.5 UNL; inadequate renal function (creatinine > 1.0 times UNL and in case of limit value, Creatinine clearance < 60 ml/min)
- Contraindication for using dexamethasone
- History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg)
- Has peripheral neuropathy ≥ grade 1
- Patient is pregnant or breast feeding
- Known severe hypersensitivity to any drugs in this study
- Treatment with any investigational drugs within 30 days before the beginning of study treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TC Arm Docetaxel, cyclophosphamide six cycles of neoadjuvant Docetaxel and Cyclophosphamide TAC Arm Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamide six cycles of neoadjuvant Docetaxel, Anthracycline and Cyclophosphamide
- Primary Outcome Measures
Name Time Method pathological complete remission (pCR) rate after 6 cycles of neoadjuvant therapy
- Secondary Outcome Measures
Name Time Method safety profile during neoadjuvant therapy clinical response rate after 6 cycles of neoadjuvant therapy breast conservation therapy (BCT) rate after surgery disease free survival (DFS) and overall survival (OS) 5-year
Trial Locations
- Locations (27)
The First People's Hospital of Foshan
🇨🇳Foshan, Guangdong, China
Guangdong Provincial Maternal and Child Health Hospital
🇨🇳Guangzhou, Guangdong, China
Guangzhou General Hospital of Guangzhou Military Area
🇨🇳Guangzhou, Guangdong, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Jiangyin People's Hospital
🇨🇳Jiangyin, Jiangsu, China
The Second Affilliated Hospital of Suzhou University
🇨🇳Suzhou, Jiangsu, China
Wujiang First People's Hospital
🇨🇳Wujiang, Jiangsu, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
Linyi People's Hospital
🇨🇳Linyi, Shandong, China
Ruijin Hospital
🇨🇳Shanghai, Shanghai, China
The third hospital of Nanchang
🇨🇳Nanchang, Jiangxi, China
Shanghai Obstetrics and Gynecology Hospital
🇨🇳Shanghai, Shanghai, China
the International Peace Maternity and Child health Hospital
🇨🇳Shanghai, Shanghai, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
Xin Hua Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanxi Provincical Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
Fisrt Affiliated Hospital of Medical College of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
West China Hospital Sichuan University
🇨🇳Chengdu, Sichuan, China
Sinkiang Uygur Autonomous Region Cancer Hospital
🇨🇳Urumqi, Xinjiang, China
Yunnan Provincical Tumor Hospital
🇨🇳Kunming, Yunnan, China
Obstetrics and Gynecology Hospital affiliated to Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Traditional Chinese Medical Hospital
🇨🇳Hangzhou, Zhejiang, China
Ningbo First People's Hospital
🇨🇳Ningbo, Zhejiang, China
The First Affilliated Hospital of Wenzhou Medical College
🇨🇳Wenzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China
Ruian People's Hospital
🇨🇳Wenzhou, Zhejiang, China