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

November 29, 2014 updated by: Sung-Bae Kim, Asan Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Second outcome measures:

2019 August, 5 year Overall Survival, Disease free survival

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: adriamycin,cytoxan, cisplatin
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 36 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Sung-Bae Kim, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 5, 2012

First Submitted That Met QC Criteria

November 28, 2013

First Posted (Estimate)

December 5, 2013

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 29, 2014

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNBC AC-CDDP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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