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NCT Number: NCT02001519

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

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

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

Second outcome measures:

2019 August, 5 year Overall Survival, Disease free survival

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. pathologic complete response (pCR) rate

    Time frame: 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 outcomes

  1. Overall response rate (ORR) by radiologic evaluation

    Time frame: 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)

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

    Time frame: up to 12 weeks

    after 2 cycles of AC

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

    Time frame: 3 years

  4. Rate of breast conservation

    Time frame: up to 36 weeks

    after surgery

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Acronym: PACER

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2013
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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