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

A Phase ll Trial of Impact of Additional 4 Cycles of Cisplatin (CDDP4) in Patients With Triple Negative Breast Cancer Not Achieving Clinical CR After 4 Cycles of Neoadjuvant Adriamycin Plus Cyclophosphamide

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02001519

Acronym

PACER

Enrollment

Registered

2013-12-05

Start date

2012-03-31

Completion date

2014-07-31

Last updated

2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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

Interventions

DRUGAC4-CDDP4

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
Complete metabolic response (CMR) rate after 2 cycles of AC	up to 12 weeks	after 2 cycles of AC
3 year disease free survival (3yr-DFS)	3 years	—
Rate of breast conservation	up to 36 weeks	after surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026