Phase 3 Trial of Carboplatin in Triple Negative Breast Cancer Patient with Residual Invasive Carcinoma After Neoadjuvant Chemotherapy
- Conditions
- Triple negative breast cancerTriple Negative Breast Neoplasms
- Registration Number
- JPRN-jRCTs051180210
- Lead Sponsor
- Kunihisa Tomonari
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 162
(1) Triple negative breast cancer patients
i) ER and PgR negative (IHC<10 %)
ii) HER2 negative (IHC 1+/0 or IHC 2+/FISH-)
(2) Patients who received Anthracycrine and Taxan treatment preoperatively received standard surgery.
(3) Patients with residual invasive cancer or lymph node metastasis on surgical specimens
(4) Within 4 months after surgery
(5) 20<= and <80 years old
(6) Written consent
(1) ER >=10 % or HER2 positive on surgical specimen
(2) previously treated with Carboplatin
(3) other cancer treated within 5 years, history of breast cancer and bilateral breast cancer
(4) severe myelosuppression
(5) sever hypersensitivity for platinum containing drugs including Carboplatin
(6)during pregnancy or breast feeding
(7) attended clinical trial within 6 month
(8) metastatic breast cancer
(9) heavy disorder of heat, kidney or liver
(10) doctor's dicision of inadequacy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method