Study Stopped
TAC treatment was associated with better survial outcome compared with TC treatment, we terminated recruiting and waiting for longer follow up period.
Neoadjuvant Treatment of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Triple-Negative or Her2 Positive Breast Cancer
NATT
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
1 other identifier
interventional
102
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Jul 2009
Typical duration for phase_3 breast-cancer
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2009
CompletedFirst Posted
Study publicly available on registry
June 3, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedNovember 22, 2016
November 1, 2016
2.8 years
June 1, 2009
November 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pathological complete remission (pCR) rate
after 6 cycles of neoadjuvant therapy
Secondary Outcomes (4)
disease free survival (DFS) and overall survival (OS)
5-year
clinical response rate
after 6 cycles of neoadjuvant therapy
safety profile
during neoadjuvant therapy
breast conservation therapy (BCT) rate
after surgery
Study Arms (2)
TAC Arm
EXPERIMENTALsix cycles of neoadjuvant Docetaxel, Anthracycline and Cyclophosphamide
TC Arm
EXPERIMENTALsix cycles of neoadjuvant Docetaxel and Cyclophosphamide
Interventions
Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 every 3 weeks for six cycles
Docetaxel 75mg/m2, cyclophosphamide 600mg/m2 every 3 weeks for six cycles
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
The First People's Hospital of Foshan
Foshan, Guangdong, 528000, China
Guangdong Provincial Maternal and Child Health Hospital
Guangzhou, Guangdong, 510010, China
Guangzhou General Hospital of Guangzhou Military Area
Guangzhou, Guangdong, 510010, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
Hunan Cancer Hospital
Changsha, Hunan, 410009, China
Jiangyin People's Hospital
Jiangyin, Jiangsu, 214440, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
The Second Affilliated Hospital of Suzhou University
Suzhou, Jiangsu, 215004, China
Wujiang First People's Hospital
Wujiang, Jiangsu, 215200, China
The third hospital of Nanchang
Nanchang, Jiangxi, 330009, China
Linyi People's Hospital
Linyi, Shandong, 276003, China
Shanghai Obstetrics and Gynecology Hospital
Shanghai, Shanghai Municipality, 200021, China
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
the International Peace Maternity and Child health Hospital
Shanghai, Shanghai Municipality, 200033, China
Xin Hua Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Shanxi Provincical Cancer Hospital
Taiyuan, Shanxi, 030013, China
Fisrt Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
West China Hospital Sichuan University
Chengdu, Sichuan, 610041, China
Sinkiang Uygur Autonomous Region Cancer Hospital
Ürümqi, Xinjiang, 830000, China
Yunnan Provincical Tumor Hospital
Kunming, Yunnan, 650106, China
Obstetrics and Gynecology Hospital affiliated to Zhejiang University
Hangzhou, Zhejiang, 310006, China
Zhejiang Traditional Chinese Medical Hospital
Hangzhou, Zhejiang, 310006, China
Ningbo First People's Hospital
Ningbo, Zhejiang, 315010, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 318050, China
The First Affilliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000, China
Ruian People's Hospital
Wenzhou, Zhejiang, 325208, China
Related Publications (4)
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.
PMID: 17152490BACKGROUNDJones 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. doi: 10.1200/JCO.2006.06.5391.
PMID: 17135639BACKGROUNDMartin 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. doi: 10.1056/NEJMoa043681.
PMID: 15930421BACKGROUNDRouzier 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. doi: 10.1158/1078-0432.CCR-04-2421.
PMID: 16115903BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kunwei Shen
Shanghai Jiao Tong University School of Medicine
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
- Professor
Study Record Dates
First Submitted
June 1, 2009
First Posted
June 3, 2009
Study Start
July 1, 2009
Primary Completion
May 1, 2012
Study Completion
October 1, 2015
Last Updated
November 22, 2016
Record last verified: 2016-11