Neoadjuvant Treatment of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Triple-Negative or Her2 Positive Breast Cancer

Condition(s) targeted: Breast Cancer

Intervention: Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamide (Drug); Docetaxel, cyclophosphamide (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Shanghai Jiao Tong University School of Medicine

Official(s) and/or principal investigator(s):
Kunwei Shen, Principal Investigator, Affiliation: Shanghai Jiao Tong University School of Medicine

Overall contact:
Kunwei Shen, Phone: 0086-0021-64370045, Ext: 601988, Email: kwshen@medmail.com.cn

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.

Official title: A Multi-Center, Randomized Study of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Neoadjuvant Treatment of Triple-Negative or Her2 Positive Breast Cancer

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

Primary outcome: pathological complete remission (pCR) rate

Secondary outcome:

disease free survival (DFS) and overall survival (OS)

clinical response rate

safety profile

breast conservation therapy (BCT) rate

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Kunwei Shen, Phone: 0086-0021-64370045, Ext: 601988, Email: kwshen@medmail.com.cn

The First People's Hospital of Foshan, Foshan, Guangdong 528000, China; Recruiting
Guolin Ye
Guolin Ye, Principal Investigator

Guangzhou General Hospital of Guangzhou Military Area, Guangzhou, Guangdong 510010, China; Recruiting
Chenfang Zhang
Chenfang Zhang, Principal Investigator

Guangdong Provincial Maternal and Child Health Hospital, Guangzhou, Guangdong 510010, China; Recruiting
Anqin Zhang
Anqin Zhang, Principal Investigator

Xiangya Hospital Central South University, Changsha, Hunan 410008, China; Completed

Hunan Cancer Hospital, Changsha, Hunan 410009, China; Completed

Jiangyin People's Hospital, Jiangyin, Jiangsu 214440, China; Recruiting
Qing Shao
Qing Shao, Principal Investigator

Jiangsu Cancer Hospital, Nanjing, Jiangsu 210009, China; Recruiting
Jinhai Tang
Jinhai Tang, Principal Investigator

The Second Affilliated Hospital of Suzhou University, Suzhou, Jiangsu 215004, China; Recruiting
Huiyun Hu
Huiyun Hu, Principal Investigator

Wujiang First People's Hospital, Wujiang, Jiangsu 215200, China; Recruiting
Xiaodong Wang
Xiaodong Wang, Principal Investigator
Weixian Huang, Principal Investigator

The third hospital of Nanchang, Nanchang, Jiangxi 330009, China; Completed

Linyi People's Hospital, Linyi, Shandong 276003, China; Recruiting
Ziguo Wei
Ziguo Wei, Principal Investigator
Hong Liang, Principal Investigator

Ruijin Hospital, Shanghai, Shanghai 200025, China; Recruiting
xiaosong chen, Phone: 0086-0021-64370045, Ext: 601988, Email: chenxiaosong0156@hotmail.com
kunwei shen, Principal Investigator

Zhongshan Hospital Fudan University, Shanghai, Shanghai 200032, China; Recruiting
Hongwei Zhang
Dingcun Luo, Principal Investigator

Shanghai Obstetrics and Gynecology Hospital, Shanghai, Shanghai 200021, China; Recruiting
Hui Song, Dr.
Hui Song, Dr., Principal Investigator

Xin Hua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai 200092, China; Recruiting
Kejin Wu, Dr
Kejin Wu, Dr., Principal Investigator

the International Peace Maternity and Child health Hospital, Shanghai, Shanghai 200033, China; Completed

Shanxi Provincical Cancer Hospital, Taiyuan, Shanxi 030013, China; Recruiting
Xinzheng Li
Xinzheng Li, Principal Investigator

Fisrt Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an, Shanxi 710061, China; Recruiting
Jianjun He
Jianjun He, Principal Investigator

West China Hospital Sichuan University, Chengdu, Sichuan 610041, China; Completed

Xinjiang Uygur Autonomous Region Cancer Hospital, Wulumuqi, Xinjiang Uygur Autonomous Region 830000, China; Recruiting
Duo Ni
Duo Ni, Dr., Principal Investigator

Yunnan Provincical Tumor Hospital, Kunming, Yunnan 650106, China; Recruiting
Dedian Chen
Dedian Chen, Principal Investigator

Obstetrics and Gynecology Hospital affiliated to Zhejiang University, Hangzhou, Zhejiang 310006, China; Recruiting
Yiding Chen, Dr.
Yiding Chen, Dr., Principal Investigator

Zhejiang Traditional Chinese Medical Hospital, Hangzhou, Zhejiang 310006, China; Recruiting
Xiaohong Xie
Xiaohong Xie, Principal Investigator

Ningbo First People's Hospital, Ningbo, Zhejiang 315010, China; Recruiting
Yu Guo
Yu Guo, Principal Investigator

Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang 318050, China; Recruiting
Yuechu Dai
Yuechu Dai, Principal Investigator

Ruian People's Hospital, Wenzhou, Zhejiang 325208, China; Recruiting
Weili Wu
Weili Wu, Principal Investigator

The First Affilliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang 325000, China; Recruiting
Xiaohua Zhang
Xiaohua Zhang, Principal Investigator

Related publications:

Yang L, Li LD, Chen YD, Parkin DM. [Time trends, estimates and projects for breast cancer incidence and mortality in China] Zhonghua Zhong Liu Za Zhi. 2006 Jun;28(6):438-40. Chinese.

Jones SE, Savin MA, Holmes FA, O'Shaughnessy JA, Blum JL, Vukelja S, McIntyre KJ, Pippen JE, Bordelon JH, Kirby R, Sandbach J, Hyman WJ, Khandelwal P, Negron AG, Richards DA, Anthony SP, Mennel RG, Boehm KA, Meyer WG, Asmar L. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol. 2006 Dec 1;24(34):5381-7. Erratum in: J Clin Oncol. 2007 May 1;25(13):1819.

Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13.

Rouzier R, Perou CM, Symmans WF, Ibrahim N, Cristofanilli M, Anderson K, Hess KR, Stec J, Ayers M, Wagner P, Morandi P, Fan C, Rabiul I, Ross JS, Hortobagyi GN, Pusztai L. Breast cancer molecular subtypes respond differently to preoperative chemotherapy. Clin Cancer Res. 2005 Aug 15;11(16):5678-85.

Starting date: July 2009
Last updated: March 22, 2012