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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001519
• Other study ID #: TNBC AC-CDDP
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2012
• Last updated: November 29, 2014
• Start date: March 2012
• Est. completion date: July 2014

Study information

• Verified date: November 2013
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Description:

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

Second outcome measures:

2019 August, 5 year Overall Survival, Disease free survival

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 36 weeks	No
Secondary	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)	up to 36 weeks	No
Secondary	Complete metabolic response (CMR) rate after 2 cycles of AC	after 2 cycles of AC	up to 12 weeks	No
Secondary	3 year disease free survival (3yr-DFS)		3 years	No
Secondary	Rate of breast conservation	after surgery	up to 36 weeks	No