The clinical trial of adjuvant chemotherapy for old breast cancer female

• Register: ChiCTR
• Last refreshed on: 28 April 2013
• Main ID: ChiCTR-TRC-11001670
• Date of registration: 2011-11-04
• Primary sponsor: The Breast and Thyroid Department of West China Hospital, Sichuan University
• Public title: The clinical trial of adjuvant chemotherapy for old breast cancer female
• Scientific title: The clinical trial of adjuvant chemotherapy for old breast cancer female
• Date of first enrolment: 2012-01-01
• Target sample size: B:116;A:116;
• Recruitment status: Pending
• URL: http://www.chictr.org/en/proj/show.aspx?proj=1999
• Study type: Interventional
• Study design: Randomized parallel control

Countries of recruitment

China

Contacts

• Name: Chen Jie

• Name: Chen Jie

Key inclusion & exclusion criteria

Inclusion criteria: •Femal, age=170years old when get into inpatient firstly, the exepcted duration survival=6months
•Has invasive breast cancer (inflammatory breast cancer or DCIS with microinvasive excluded) confirmed by core needle biopsy (CNB) and pathologic analysis.
•The ER, PR and HER-2 all were negative confirmed by postoperation pathology,or the HER-2 was positive but the patients refused the threatment of herceptin.
•The metastasis of axillary lymph node=1 (micrometasasis excluded)
•without history of other neoplasms (except nonmelanoma skin cancer or curatively treated carcinoma-in-situ of the cervix).
•adequate bone marrow , normal CBC(neutrophils =2.5×109/L, platelets=100×109/L, Hb= 100g/L), without blood coagulation disorder
•adequate renal (serum creatinine=110umol/L,BUN=7.1mmol/L) and liver function(serum bilirubin=1.5 times upper normal limit, and AST= 60 U/L ).
•
•ECOG Performance Status (PS) 0-1.
•normal cardiac function as evidenced by a normal ECG and LVEF=55%
•agreed to accept the postoperative chemotherapy and other necessary treatment
•signed a Patient Informed Consent Form
Exclusion criteria: •Has had previous systemic chemotherapy or local treatment for this breast cancer (topical application excluded).
•Has any evidence of distant metastasis at diagnosis of breast cancer.
•Has a serious uncontrolled intercurrent medical illness, including serious viral (including clinically defined AIDS), bacterial or fungal infection; or history of uncontrolled peptic ulcers, or diabetes, or blood coagulation disorders, or autoimmune diseases, or bone marrow suppression, etc. deemed by the treating physician to be clinically impossible to tolerate the chemotherapy.
•heart failure, uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or uncontrolled hypertension (systolic pressure>180mmHg or diastolic pressure>100mmHg).
•Unwilling to undergo the postoperation chemotherapy.
•Has history of psychiatric disorders and other unidentified medical problems resulting in poor compliance to the treatment.
•Has a history of severe hypersensitivity reaction to preparations pertaining to the chemotherapy.

Age minimum: 70
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

the breast cancer

Intervention(s)

B:postoperation chemotherapy(TC:docetaxel 75 mg/m2 IV d1. cyclophosphamidum 600 mg/m2 IV d1. 21d is a cycle and totally 6 cycles;A:without postoperation;

Primary Outcome(s)

disease free survival(DSF);overall survival(OS);

Source(s) of Monetary Support

selffinancing

Secondary Sponsor(s)

The Breast and Thyroid Department of West China Hospital, Sichuan University