JRCT ID: jRCTs051180210
Registered date:27/03/2019
Phase 3 Trial of Carboplatin in Triple Negative Breast Cancer Patient with Residual Invasive Carcinoma After Neoadjuvant Chemotherapy
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Triple negative breast cancer |
Date of first enrollment | 09/06/2020 |
Target sample size | 162 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Carboplatin AUC6 q3wks x4 |
Outcome(s)
Primary Outcome | Disease free survival |
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Secondary Outcome | Safety, over all survival |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 79age old |
Gender | Female |
Include criteria | (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 |
Exclude criteria | (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 |
Related Information
Primary Sponsor | Kunihisa Tomonari |
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Secondary Sponsor | Tanino Hirokazu |
Source(s) of Monetary Support | |
Secondary ID(s) | UMIN000030780 |
Contact
Public contact | |
Name | Hirokazu Tanino |
Address | 811-1 Kimiidera, Wakayama, Wakayama Wakayama Japan 641-8509 |
Telephone | +81-73-441-0615 |
htanino@wakayama-med.ac.jp | |
Affiliation | Wakayama Medical University |
Scientific contact | |
Name | Tomonari Kunihisa |
Address | 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo Hyogo Japan 650-0017 |
Telephone | +81-78-382-5111 |
kunihisa@med.kobe-u.ac.jp | |
Affiliation | Kobe University Hospital |