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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: AC4-CDDP4

• Registration Number: NCT02001519
• Lead Sponsor: Asan Medical Center

Brief 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.

Detailed Description

First outcome measures (analysis) :at the time of surgery,

Second outcome measures:

2019 August, 5 year Overall Survival, Disease free survival

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-07-05
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-28
• Study First Posted: 2013-12-05
• Primary Completion: 2014-02
• Study Completion: 2014-07
• Last Update Submitted: 2014-11-29
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
adriamycin,cytoxan, cisplatin	AC4-CDDP4	4 cycles of Adriamycin 60 mg/m2 and Cyclophosphamide 600 mg/m2 every 3 weeks followed by 4 cycles of cisplatin 75 mg/m2 every 3 weeks

Primary Outcome Measures

Name	Time	Method
pathologic complete response (pCR) rate	up to 36 weeks	Rate of pCR (as defined by NSABP \[National Surgical Adjuvant Breast and Bowel Project\] criteria - absence of invasive disease in the breast \[ypT0\]) at the time of surgery.

Secondary Outcome Measures

Name	Time	Method
3 year disease free survival (3yr-DFS)	3 years
Complete metabolic response (CMR) rate after 2 cycles of AC	up to 12 weeks	after 2 cycles of AC
Rate of breast conservation	up to 36 weeks	after surgery
Overall response rate (ORR) by radiologic evaluation	up to 36 weeks	after completion of chemotherapy Overall objective clinical response rate = CR (complete response) + PR (partial response) rate, measured by US (or MRI) and assessed by Response Evaluation Criteria in Solid Tumors (RECIST)

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of