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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00912444
• Other study ID #: NATT
• Status: Terminated
• Phase: Phase 3
• First received: June 1, 2009
• Last updated: November 19, 2016
• Start date: July 2009
• Est. completion date: October 2015

Study information

• Verified date: November 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 102
• Est. completion date: October 2015
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamide
Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 every 3 weeks for six cycles
• Docetaxel, cyclophosphamide
Docetaxel 75mg/m2, cyclophosphamide 600mg/m2 every 3 weeks for six cycles

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital Sichuan University	Chengdu	Sichuan
China	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	Obstetrics and Gynecology Hospital affiliated to Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Traditional Chinese Medical Hospital	Hangzhou	Zhejiang
China	Jiangyin People's Hospital	Jiangyin	Jiangsu
China	Yunnan Provincical Tumor Hospital	Kunming	Yunnan
China	Linyi People's Hospital	Linyi	Shandong
China	The third hospital of Nanchang	Nanchang	Jiangxi
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Ningbo First People's Hospital	Ningbo	Zhejiang
China	Ruijin Hospital	Shanghai	Shanghai
China	Shanghai Obstetrics and Gynecology Hospital	Shanghai	Shanghai
China	the International Peace Maternity and Child health Hospital	Shanghai	Shanghai
China	Xin Hua Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
China	The Second Affilliated Hospital of Suzhou University	Suzhou	Jiangsu
China	Shanxi Provincical Cancer Hospital	Taiyuan	Shanxi
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	Sinkiang Uygur Autonomous Region Cancer Hospital	Urumqi	Xinjiang
China	Ruian People's Hospital	Wenzhou	Zhejiang
China	The First Affilliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang
China	Wujiang First People's Hospital	Wujiang	Jiangsu
China	Fisrt Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological complete remission (pCR) rate		after 6 cycles of neoadjuvant therapy	No
Secondary	disease free survival (DFS) and overall survival (OS)		5-year	No
Secondary	clinical response rate		after 6 cycles of neoadjuvant therapy	No
Secondary	safety profile		during neoadjuvant therapy	Yes
Secondary	breast conservation therapy (BCT) rate		after surgery	No

External Links

•   published result link