Phase 3 Trial of Carboplatin in Triple Negative Breast Cancer Patient with Residual Invasive Carcinoma After Neoadjuvant Chemotherapy

JRCT ID: jRCTs051180210

Registered date:27/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Triple negative breast cancer
• Date of first enrollment: 09/06/2020
• Target sample size: 162
• Study type: Interventional
• Intervention(s): Carboplatin AUC6 q3wks x4

Outcome(s)

• Primary Outcome: Disease free survival
• Secondary Outcome: Safety, over all survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• 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
• Secondary Sponsor: Tanino Hirokazu
• Secondary ID(s): UMIN000030780