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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AC4-CDDP4
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

adriamycin,cytoxan, cisplatin

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall response rate (ORR) by radiologic evaluation
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
after 2 cycles of AC
3 year disease free survival (3yr-DFS)
Rate of breast conservation
after surgery

Full Information

First Posted
July 5, 2012
Last Updated
November 29, 2014
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02001519
Brief Title
Additional 4 Cycles of Cisplatin (CDDP4) in Patients With Triple Negative Breast Cancer for Neoadjuvant Chemotherapy
Acronym
PACER
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
adriamycin,cytoxan, cisplatin
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
AC4-CDDP4
Intervention Description
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 Outcome Measure Information:
Title
pathologic complete response (pCR) rate
Description
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.
Time Frame
up to 36 weeks
Secondary Outcome Measure Information:
Title
Overall response rate (ORR) by radiologic evaluation
Description
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)
Time Frame
up to 36 weeks
Title
Complete metabolic response (CMR) rate after 2 cycles of AC
Description
after 2 cycles of AC
Time Frame
up to 12 weeks
Title
3 year disease free survival (3yr-DFS)
Time Frame
3 years
Title
Rate of breast conservation
Description
after surgery
Time Frame
up to 36 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Bae Kim
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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