NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedTriple negative breast cancer
Date of first enrollment09/06/2020
Target sample size162
Countries of recruitment
Study typeInterventional
Intervention(s)Carboplatin AUC6 q3wks x4

Outcome(s)

Primary OutcomeDisease free survival
Secondary OutcomeSafety, over all survival

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 79age old
GenderFemale
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

Contact

Public contact
Name Hirokazu Tanino
Address 811-1 Kimiidera, Wakayama, Wakayama Wakayama Japan 641-8509
Telephone +81-73-441-0615
E-mail 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
E-mail kunihisa@med.kobe-u.ac.jp
Affiliation Kobe University Hospital