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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamide
Docetaxel, cyclophosphamide
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Neoplasms, Neoadjuvant, Chemotherapy, Docetaxel, Cyclophosphamide, Anthracycline

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The First People's Hospital of Foshan
  • Guangdong Provincial Maternal and Child Health Hospital
  • Guangzhou General Hospital of Guangzhou Military Area
  • Xiangya Hospital Central South University
  • Hunan Cancer Hospital
  • Jiangyin People's Hospital
  • Jiangsu Cancer Hospital
  • The Second Affilliated Hospital of Suzhou University
  • Wujiang First People's Hospital
  • The third hospital of Nanchang
  • Linyi People's Hospital
  • Shanghai Obstetrics and Gynecology Hospital
  • Ruijin Hospital
  • Zhongshan Hospital Fudan University
  • the International Peace Maternity and Child health Hospital
  • Xin Hua Hospital, Shanghai Jiaotong University School of Medicine
  • Shanxi Provincical Cancer Hospital
  • Fisrt Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • West China Hospital Sichuan University
  • Sinkiang Uygur Autonomous Region Cancer Hospital
  • Yunnan Provincical Tumor Hospital
  • Obstetrics and Gynecology Hospital affiliated to Zhejiang University
  • Zhejiang Traditional Chinese Medical Hospital
  • Ningbo First People's Hospital
  • Taizhou Hospital of Zhejiang Province
  • The First Affilliated Hospital of Wenzhou Medical College
  • Ruian People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TAC Arm

TC Arm

Arm Description

six cycles of neoadjuvant Docetaxel, Anthracycline and Cyclophosphamide

six cycles of neoadjuvant Docetaxel and Cyclophosphamide

Outcomes

Primary Outcome Measures

pathological complete remission (pCR) rate

Secondary Outcome Measures

disease free survival (DFS) and overall survival (OS)
clinical response rate
safety profile
breast conservation therapy (BCT) rate

Full Information

First Posted
June 1, 2009
Last Updated
November 19, 2016
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00912444
Brief Title
Neoadjuvant Treatment of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Triple-Negative or Her2 Positive Breast Cancer
Acronym
NATT
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 Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
TAC treatment was associated with better survial outcome compared with TC treatment, we terminated recruiting and waiting for longer follow up period.
Study Start Date
July 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Neoplasms, Neoadjuvant, Chemotherapy, Docetaxel, Cyclophosphamide, Anthracycline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAC Arm
Arm Type
Experimental
Arm Description
six cycles of neoadjuvant Docetaxel, Anthracycline and Cyclophosphamide
Arm Title
TC Arm
Arm Type
Experimental
Arm Description
six cycles of neoadjuvant Docetaxel and Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamide
Intervention Description
Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 every 3 weeks for six cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel, cyclophosphamide
Intervention Description
Docetaxel 75mg/m2, cyclophosphamide 600mg/m2 every 3 weeks for six cycles
Primary Outcome Measure Information:
Title
pathological complete remission (pCR) rate
Time Frame
after 6 cycles of neoadjuvant therapy
Secondary Outcome Measure Information:
Title
disease free survival (DFS) and overall survival (OS)
Time Frame
5-year
Title
clinical response rate
Time Frame
after 6 cycles of neoadjuvant therapy
Title
safety profile
Time Frame
during neoadjuvant therapy
Title
breast conservation therapy (BCT) rate
Time Frame
after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kunwei Shen
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First People's Hospital of Foshan
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Facility Name
Guangdong Provincial Maternal and Child Health Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Facility Name
Guangzhou General Hospital of Guangzhou Military Area
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410009
Country
China
Facility Name
Jiangyin People's Hospital
City
Jiangyin
State/Province
Jiangsu
ZIP/Postal Code
214440
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
The Second Affilliated Hospital of Suzhou University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
Wujiang First People's Hospital
City
Wujiang
State/Province
Jiangsu
ZIP/Postal Code
215200
Country
China
Facility Name
The third hospital of Nanchang
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330009
Country
China
Facility Name
Linyi People's Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276003
Country
China
Facility Name
Shanghai Obstetrics and Gynecology Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200021
Country
China
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
the International Peace Maternity and Child health Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200033
Country
China
Facility Name
Xin Hua Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Shanxi Provincical Cancer Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030013
Country
China
Facility Name
Fisrt Affiliated Hospital of Medical College of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Sinkiang Uygur Autonomous Region Cancer Hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Facility Name
Yunnan Provincical Tumor Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650106
Country
China
Facility Name
Obstetrics and Gynecology Hospital affiliated to Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
Zhejiang Traditional Chinese Medical Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
Ningbo First People's Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
318050
Country
China
Facility Name
The First Affilliated Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
Ruian People's Hospital
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325208
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
17152490
Citation
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.
Results Reference
background
PubMed Identifier
17135639
Citation
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. doi: 10.1200/JCO.2006.06.5391. Erratum In: J Clin Oncol. 2007 May 1;25(13):1819.
Results Reference
background
PubMed Identifier
15930421
Citation
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. doi: 10.1056/NEJMoa043681.
Results Reference
background
PubMed Identifier
16115903
Citation
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. doi: 10.1158/1078-0432.CCR-04-2421.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/24292815
Description
published result link

Learn more about this trial

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

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