Stage II Breast CancerPhase 2NCT02115152
Neoadjuvant Trial of Capecitabine for Axillary Lymph Node Positive Operable Breast Cancer
A Phase 2 study testing fluorouracil, capecitabine and cyclophosphamide in people with Stage II Breast Cancer and Stage III Breast Cancer, run by Guangxi Medical University at 1 site in China.
Trial summary
This randomized phase II trial compared pathologic response rates (pCR) of early breast cancer following neoadjuvant fluorouracil-epirubicin-cyclophosphamide(FEC) and capecitabine-epirubicin-cyclophosphamide (XEC). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Stage II Breast Cancer, Stage III Breast Cancer
- What is being tested?
- fluorouracil, capecitabine and cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Jun 2018
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged 18-70 with histologically proven, core-biopsied, Stage II-III invasive breast cancer
- No distant disease
Who cannot join
- Inadequate heart or liver or kidney function
Trial locations and contacts
1 site in 1 country.
Jianlun Liu contact
China1 site
Breast Cancer Surgery Department of Guangxi Medical University Cancer Center
Nanning, Guangxi
Jianlun Liu, MD
About this study
Official title: Phase II Neoadjuvant Trial of Capecitabine, Cyclophosphamide and Epirubicin for Patients With Axillary Lymph Node Positive Stage II-III Operable Breast Cancer
This randomized phase II trial compared pathologic response rates (pCR) of early breast cancer following neoadjuvant fluorouracil-epirubicin-cyclophosphamide(FEC) and capecitabine-epirubicin-cyclophosphamide (XEC).
- Conditions
- Stage II Breast Cancer, Stage III Breast Cancer
- Being tested
- fluorouracil, capecitabine, cyclophosphamide, Epirubicin
- Keywords
- Capecitabine, Neoadjuvant therapy, Early Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorouracilDrug
capecitabineDrug
cyclophosphamideDrug
EpirubicinDrug
| Study group | Role | What they receive |
|---|---|---|
| FEC | Active comparator | Patients will be randomized to received 4 cycles of fluorouracil, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel after surgery. Receives: Drug: fluorouracil; Drug: cyclophosphamide; Drug: Epirubicin |
| XEC | Experimental | Patients will be randomized to received 4 cycles of capecitabine, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel and capecitabine after surgery. Receives: Drug: capecitabine; Drug: cyclophosphamide; Drug: Epirubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic response rates (pCR)
The absence of invasive tumor in the final surgical breast sample (stage yT0 or ypTis)
Measured: The breast sample will be evaluaed on the day of surgery during the cycle 4, an expected average of 12 weeks.
Secondary outcomes (2)
DFS(Disease free survial)
Time from randmization to breast-cancer recurrence, or a second primay cancer(ecluding contralateral ducal carcinoma in situ), or death from any cause, whichever comes first
Measured: Participants will be evaluated on Day 1 of each cycle during chemotherapy, and Day 1 every 3 months after completion of chemotherapy. The expected average of 5 years.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Adverse events are classified accoding NCI CTC criteria.
Measured: Hematologic, renal, and hepatic funcion will be assessed after each cycle and at the end of therapy, an expected average of 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II Breast CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianlun Liu, Guangxi Medical University
- Investigators
- Jianlun Liu, MD, Principal investigator, Guangxi Medical University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115152
- Sponsor's protocol ID
- JLiu
- Status last verified
- Apr 2014
- First submitted
- 24 Mar 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Neoadjuvant Trial of Capecitabine, Cyclophosphamide and Epirubicin for Patients With Axillary Lymph Node Positive Stage II-III Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT02115152
- Acronym / sponsor ID
- JLiu
- Conditions
- Stage II Breast Cancer, Stage III Breast Cancer
- Keywords
- Capecitabine, Neoadjuvant therapy, Early Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2018 (estimated)
- First posted
- 15 Apr 2014 (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.
This randomized phase II trial compared pathologic response rates (pCR) of early breast cancer following neoadjuvant fluorouracil-epirubicin-cyclophosphamide(FEC) and capecitabine-epirubicin-cyclophosphamide (XEC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FEC | Active comparator | Drug: fluorouracil, Drug: cyclophosphamide, Drug: EpirubicinPatients will be randomized to received 4 cycles of fluorouracil, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel after surgery. |
| XEC | Experimental | Drug: capecitabine, Drug: cyclophosphamide, Drug: EpirubicinPatients will be randomized to received 4 cycles of capecitabine, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel and capecitabine after surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females aged 18-70 with histologically proven, core-biopsied, Stage II-III invasive breast cancer
- No distant disease
Key exclusion criteria (1 listed)
- Inadequate heart or liver or kidney function
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 |
|---|---|---|
| fluorouracil | Drug | FEC |
| capecitabine | Drug | XEC |
| cyclophosphamide | Drug | FEC, XEC |
| Epirubicin | Drug | FEC, XEC |
Primary outcome
pathologic response rates (pCR)
Time frame: The breast sample will be evaluaed on the day of surgery during the cycle 4, an expected average of 12 weeks.
The absence of invasive tumor in the final surgical breast sample (stage yT0 or ypTis)
2 secondary outcomes
DFS(Disease free survial)
Time frame: Participants will be evaluated on Day 1 of each cycle during chemotherapy, and Day 1 every 3 months after completion of chemotherapy. The expected average of 5 years.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Hematologic, renal, and hepatic funcion will be assessed after each cycle and at the end of therapy, an expected average of 3 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 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.
Jianlun Liu contact
Jianlun Liu, MD principal investigator
Guangxi Medical University Cancer 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 fluorouracil, capecitabine and cyclophosphamide in people with Stage II Breast Cancer and Stage III Breast Cancer, run by Guangxi Medical University at 1 site in China.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Apr 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianlun Liu (jianlunliu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic response rates (pCR) (time frame: The breast sample will be evaluaed on the day of surgery during the cycle 4, an expected average of 12 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 15 Apr 2014.