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

Asan Medical Center

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: AC4-CDDP4

Study type: Interventional

Funder types: Other

Identifiers

NCT02001519

TNBC AC-CDDP

Details and patient eligibility

About

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.

Full description

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

Second outcome measures:

2019 August, 5 year Overall Survival, Disease free survival

Enrollment: 88 patients

Sex: Female

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

adriamycin,cytoxan, cisplatin

Experimental group

Description:

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

Treatment:

Drug: AC4-CDDP4