Additional 4 Cycles of Cisplatin (CDDP4) in Patients With Triple Negative Breast Cancer for Neoadjuvant Chemotherapy

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

Achievement of pathologic complete response is important prognosticator to predict long term outcome in triple negative cancer. The efficacy of adding 4 cycles of cisplatin (CDDP4) is to be investigated whether addtional pathologic complete response is achieved for those triple negative breast cancer patients who recieved 4 cycles of adriamycin with cyclophosphamide(AC4) but did not reach clinical complete response during the course of neoadjuvant therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Cisplatin; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

1. Patients with histologically proven breast cancer

2. Age, at least 20 years

3. ER/PR/HER2 (negative/negative/negative

• ER/PR negative: nuclear reaction < 1%, Allred score 0 or 2

• HER2 negative: HER2; IHC (immunohistochemistry) 0,1+ or FISH/SISH (-) in case of IHC 2+

4. Clinically stage II or III with histologically proven lymph-node involvement (T >1.5 cm or lymph node [LN] >1.5 cm)

5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

6. No prior hormonal treatment, chemotherapy or radiotherapy is allowed.

7. Adequate hematologic, liver and kidney function

8. Written informed consent

Exclusion Criteria:

1. Pregnancy or lactation

2. Prior chemotherapy or radiotherapy for any malignancy

3. Stage T4d; inflammatory breast cancer

4. No primary tumor (T0)

5. Documented history of cardiac disease contraindicating anthracyclines

6. Currently active infection