Breast CancerPhase 2PACERNCT02001519
Additional 4 Cycles of Cisplatin (CDDP4) in Patients With Triple Negative Breast Cancer for Neoadjuvant Chemotherapy
A Phase 2 study testing AC4-CDDP4 in people with Breast Cancer, run by Asan Medical Center at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- AC4-CDDP4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
First outcome measures (analysis) :at the time of surgery,
Second outcome measures:
2019 August, 5 year Overall Survival, Disease free survival
- Conditions
- Breast Cancer
- Being tested
- AC4-CDDP4
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC4-CDDP4Drug
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
| Study group | Role | What they receive |
|---|---|---|
| adriamycin,cytoxan, cisplatin | Experimental | 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 Receives: Drug: AC4-CDDP4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 36 weeks
Secondary outcomes (4)
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)
Measured: up to 36 weeks
Complete metabolic response (CMR) rate after 2 cycles of AC
after 2 cycles of AC
Measured: up to 12 weeks
3 year disease free survival (3yr-DFS)
Measured: 3 years
Rate of breast conservation
after surgery
Measured: up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startMar 2012
- Primary completionFeb 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Bae Kim, Asan Medical Center
- Investigators
- Sung-Bae Kim, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001519
- Sponsor's protocol ID
- TNBC AC-CDDP
- Acronym
- PACER
- Status last verified
- Nov 2013
- First submitted
- 5 Jul 2012
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02001519
- Acronym / sponsor ID
- PACER / TNBC AC-CDDP
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adriamycin,cytoxan, cisplatin | Experimental | Drug: AC4-CDDP44 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically proven breast cancer
- Age, at least 20 years
- ER/PR/HER2 (negative/negative/negative
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AC4-CDDP44 cycles of Adriamycin 60 mg/m2 and Cyclophosphamide 600 mg/m2 every 3 weeks 4 cycles of cisplatin 75 mg/m2 every 3 weeks | Drug | adriamycin,cytoxan, cisplatin |
Primary outcome
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.
4 secondary outcomes
Overall response rate (ORR) by radiologic evaluation
Time frame: up to 36 weeks
Complete metabolic response (CMR) rate after 2 cycles of AC
Time frame: up to 12 weeks
3 year disease free survival (3yr-DFS)
Time frame: 3 years
Rate of breast conservation
Time frame: up to 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Bae Kim principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AC4-CDDP4 in people with Breast Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response (pCR) rate (time frame: up to 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.