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

NCT02001519 | Completed Phase 2

• 1 other identifier: TNBC AC-CDDP
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• pathologic complete response (pCR) rate

  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.

  up to 36 weeks

Secondary Outcomes (4)

• Overall response rate (ORR) by radiologic evaluation

  up to 36 weeks

• Complete metabolic response (CMR) rate after 2 cycles of AC

  up to 12 weeks

• 3 year disease free survival (3yr-DFS)

  3 years

• Rate of breast conservation

  up to 36 weeks

Study Arms (1)

adriamycin,cytoxan, cisplatin

EXPERIMENTAL

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

Drug: AC4-CDDP4

Interventions

AC4-CDDP4 DRUG

4 cycles of Adriamycin 60 mg/m2 and Cyclophosphamide 600 mg/m2 every 3 weeks 4 cycles of cisplatin 75 mg/m2 every 3 weeks

adriamycin,cytoxan, cisplatin

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically proven breast cancer
• Age, at least 20 years
• 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+
• Clinically stage II or III with histologically proven lymph-node involvement (T \>1.5 cm or lymph node \[LN\] \>1.5 cm)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• No prior hormonal treatment, chemotherapy or radiotherapy is allowed.
• Adequate hematologic, liver and kidney function
• Written informed consent

You may not qualify if:

• Pregnancy or lactation
• Prior chemotherapy or radiotherapy for any malignancy
• Stage T4d; inflammatory breast cancer
• No primary tumor (T0)
• Documented history of cardiac disease contraindicating anthracyclines
• Currently active infection

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sung-Bae Kim

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: December 5, 2013
• Study Start: March 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2013-11

Locations

KR (1)