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Clinical Trials/JPRN-jRCTs051180210
JPRN-jRCTs051180210
Recruiting
Phase 3

Phase 3 Trial of Carboplatin in Triple Negative Breast Cancer Patient with Residual Invasive Carcinoma After Neoadjuvant Chemotherapy - Phase 3 Trial of Carboplatin in Triple Negative Breast Cancer Patient with Residual Invasive Carcinoma After Neoadjuvant Chemotherapy (JONIE4/JCaT)

Kunihisa Tomonari0 sites162 target enrollmentMarch 27, 2019
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Kunihisa Tomonari
Enrollment
162
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 27, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Kunihisa Tomonari

Eligibility Criteria

Inclusion 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

Exclusion 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

Outcomes

Primary Outcomes

Not specified

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