Breast CancerPhase 3Neo-shorterNCT02001506
Neoadjuvant Chemotherapy of 6 Cycles vs 8 Cycles in Node Positve Breast Cancer
A Phase 3 study testing FEC3-D3 in people with Breast Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and sequential treatment of anthracyclines followed by taxanes, which has shown superior pathologic complete respone (pCR) rate (NSABP-B27 study) is widely used until now. 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?
- FEC3-D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Dec 2015
- Phase
- Phase 3
- 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
- Performance status 0 or 1
- Clinically stage 2 or 3 with histologically proven lymph node involvement
- Tumor or lymph node greater than 1.5 cm
Who cannot join
- Pregnancy or lactation
- Prior chemotherapy or radiotherapy for any malignancy
- 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 Randomized Phase III Trial of Neoadjuvant Chemotherapy With 3 Cycles of FEC Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Adriamycin Plus Cyclophosphamide Followed by 4 Cycles of Docetaxel in Node-positive Breast Cancer
Various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and sequential treatment of anthracyclines followed by taxanes, which has shown superior pathologic complete respone (pCR) rate (NSABP-B27 study) is widely used until now. Considering the proven efficacy and tolerable toxicity of 3 cycles of FEC followed by 3 cycles of Docetaxel (FEC3-D3) compared to FEC 6 cycles in adjuvant chemotherapy (PACS 01 trial), use of FEC3-D3 regimen in neoadjuvant setting will be feasible with acceptable efficacy and further reduce the duration of neoadjuvant chemotherapy.
Read the detailed description
To investigate feasibility of FEC3-D3 regimen in neoadjuvant setting in terms of comparable efficacy and shorter duration across all subtypes.
- Conditions
- Breast Cancer
- Being tested
- FEC3-D3
- Keywords
- breast cancer, neoadjuvant, different number of chemotherapy cycles
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEC3-D3Drug
Also called 5-FU, Pharmorubicin, Cytoxan, Docetaxel
Fluorouracil 500 mg/m2, every 3 weeks Epirubicin 100 mg/m2, every 3 weeks Cyclophosphamide 500, every 3 weeks
Docetaxel 75 mg/m2, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| FEC3-D3 | Active comparator | 3 cycles of FEC followed by 3 cycles of Docetaxel
Fluorouracil 500 mg/m2, every 3 weeks Epirubicin 100 mg/m2, every 3 weeks Cyclophosphamide 500, every 3 weeks
Docetaxel 75 mg/m2, every 3 weeks Receives: Drug: FEC3-D3 |
| AC4-D4 | No intervention | 4 cycles of Adriamycin plus Cyclophosphamide (AC) followed by 4 cycles of Docetaxel Adriamycin 60 mg/m2, every 3 weeks Cyclophosphamide 600 mg/m2, every 3 weeks Docetaxel 75 mg/m2, every 3 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response (pCR) between two arms
Measured: within the first 30 days (plus or minus 3 days) after surgery
Secondary outcomes (1)
3 year-disease free survival between two arms
- Correlation of pCR and Ki-67 expression at baseline and D14 tumor specimen
- 3 year-disease free survival
- Correlation of pCR and biomarkers such as Ki-67 expression
Measured: 3 year after surgery
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 startNov 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 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, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001506
- Sponsor's protocol ID
- 2012-0116
- Acronym
- Neo-shorter
- Status last verified
- Aug 2017
- First submitted
- 19 Nov 2013
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hwang I, Kim JE, Jeong JH, Ahn JH, Jung KH, Son BH, Kim HH, Shin J, Lee HJ, Gong G, Kim SB. Randomized phase III trial of a neoadjuvant regimen of four cycles of adriamycin plus cyclophosphamide followed by four cycles of docetaxel (AC4-D4) versus a shorter treatment of three cycles of FEC followed by three cycles of docetaxel (FEC3-D3) in node-positive breast cancer (Neo-shorter; NCT02001506). Breast Cancer Res Treat. 2023 Sep;201(2):193-204. doi: 10.1007/s10549-023-06971-7. Epub 2023 Jun 26.
PubMed 37365483
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial of Neoadjuvant Chemotherapy With 3 Cycles of FEC Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Adriamycin Plus Cyclophosphamide Followed by 4 Cycles of Docetaxel in Node-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT02001506
- Acronym / sponsor ID
- Neo-shorter / 2012-0116
- Conditions
- Breast Cancer
- Keywords
- breast cancer, neoadjuvant, different number of chemotherapy cycles
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (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.
Various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and sequential treatment of anthracyclines followed by taxanes, which has shown superior pathologic complete respone (pCR) rate (NSABP-B27 study) is widely used until now. Considering the proven efficacy and tolerable toxicity of 3 cycles of FEC followed by 3 cycles of Docetaxel (FEC3-D3) compared to FEC 6 cycles in adjuvant chemotherapy (PACS 01 trial), use of FEC3-D3 regimen in neoadjuvant setting will be feasible with acceptable efficacy and further reduce the duration of neoadjuvant chemotherapy.
Detailed description
To investigate feasibility of FEC3-D3 regimen in neoadjuvant setting in terms of comparable efficacy and shorter duration across all subtypes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FEC3-D3 | Active comparator | Drug: FEC3-D33 cycles of FEC followed by 3 cycles of Docetaxel Fluorouracil 500 mg/m2, every 3 weeks Epirubicin 100 mg/m2, every 3 weeks Cyclophosphamide 500, every 3 weeks Docetaxel 75 mg/m2, every 3 weeks |
| AC4-D4 | No intervention | –4 cycles of Adriamycin plus Cyclophosphamide (AC) followed by 4 cycles of Docetaxel Adriamycin 60 mg/m2, every 3 weeks Cyclophosphamide 600 mg/m2, every 3 weeks Docetaxel 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 (3 listed)
- Performance status 0 or 1
- Clinically stage 2 or 3 with histologically proven lymph node involvement
- Tumor or lymph node greater than 1.5 cm
Key exclusion criteria (4 listed)
- Pregnancy or lactation
- Prior chemotherapy or radiotherapy for any malignancy
- Documented history of cardiac disease contraindicating anthracyclines
- Currently active infection
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 |
|---|---|---|
| FEC3-D3Also: 5-FU, Pharmorubicin, Cytoxan, DocetaxelFluorouracil 500 mg/m2, every 3 weeks Epirubicin 100 mg/m2, every 3 weeks Cyclophosphamide 500, every 3 weeks Docetaxel 75 mg/m2, every 3 weeks | Drug | FEC3-D3 |
Primary outcome
pathologic complete response (pCR) between two arms
Time frame: within the first 30 days (plus or minus 3 days) after surgery
1 secondary outcome
3 year-disease free survival between two arms
Time frame: 3 year after surgery
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 29 Aug 2017.
- Derived from this study: PubMed 37365483Hwang I, Kim JE, Jeong JH, Ahn JH, Jung KH, Son BH, Kim HH, Shin J, Lee HJ, Gong G, Kim SB. Randomized phase III trial of a neoadjuvant regimen of four cycles of adriamycin plus cyclophosphamide followed by four cycles of docetaxel (AC4-D4) versus a shorter treatment of three cycles of FEC followed by three cycles of docetaxel (FEC3-D3) in node-positive breast cancer (Neo-shorter; NCT02001506). Breast Cancer Res Treat. 2023 Sep;201(2):193-204. doi: 10.1007/s10549-023-06971-7. Epub 2023 Jun 26.
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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, MD, PhD 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 3 study testing FEC3-D3 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 3 inclusion and 4 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 29 Aug 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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) between two arms (time frame: within the first 30 days (plus or minus 3 days) after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02001506, which also lists 1 linked publication.
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 29 Aug 2017.