Locally Advanced Breast CancerPhase 4NCT01660542
An Open-label, Multi-center Phase Ⅳ Trial to Evaluate the Efficacy and Safety of Sequential Neoadjuvant Chemotherapy With Docetaxel(Monotaxel®) After Doxorubicin Plus Cyclophosphamide Combination Chemotherapy in Locally Advanced Breast Cancer
A Phase 4 study testing Neoadjuvant Chemotherapy with Docetaxel in people with Locally Advanced Breast Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by 4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or cytologically confirmed axillary lymph nodes… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Locally Advanced Breast Cancer
- What is being tested?
- Neoadjuvant Chemotherapy with Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2011to Jun 2015
- Phase
- Phase 4
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically proven invasive breast cancer - the primary tumor size is at least 5cm or cytologically proven axillary node metastasis
- no evidence of systemic metastasis pathologically or radiologically
- age at the time of diagnosis between 20 and 70 years
- patients with previously untreated primary breast cancer including chemotherapy
- general performance status with ECOG 0-2
- sufficient hematopoietic function (absolute neutrophil count of ≥ 1,500/mm3, platelet count of ≥ 100,000/mm3, and hemoglobin of ≥ 10 g/dL)
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- sufficient renal function (serum creatinine level of ≤ 1.5 mg/dL)
- sufficient liver function (total serum bilirubin level ≤ 1.5 times the upper normal limit; serum AST and ALT levels ≤ 1.5 times the upper normal limit; and serum alkaline phosphatase level ≤ 1.5 times the upper normal limit)
- sufficient cardiac function (normal electrocardiography within 1 month or LVEF>50% by echocardiography or MUGA scan within 3 months)
- patients who agree to enroll this clinical trial and sign the written informed consent voluntarily
Who cannot join
- patients with evidence of distant metastases
- patients with other previous malignancy except breast cancer
- pregnant (positive hCG test 1 week before registration) or lactating patient
- uncontrolled serious infection
- patients with psychiatric disease or epilepsy
- patients with clinically severe cardiac disease within 6 months such as atrial or ventricular arrhythmia, congestive heart failure, myocardial infarction, or unstable angina
- male breast cancer
- patients with poor general condition who are not able to understand or sign the written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by 4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or cytologically confirmed axillary lymph nodes metastasis.
- Conditions
- Locally Advanced Breast Cancer
- Being tested
- Neoadjuvant Chemotherapy with Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Chemotherapy with DocetaxelDrug
Doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 (day 1), IV (in the vein), every 21 days, a total of 4 cycles -> Docetaxel 100 mg/m2 (day 1) IV, every 21 days, a total of 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| doxorubicin/cyclophosphamide | Experimental | Neoadjuvant Chemotherapy with Docetaxel(Monotaxel®) after Doxorubicin plus Cyclophosphamide Receives: Drug: Neoadjuvant Chemotherapy with Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response
Pathologic complete response is defined as the disappearance of all invasive cancer in the postsurgical breast and lymph node specimens after completion of neoadjuvant chemotherapy. Only residual intraductal carcinoma in the postsurgical breast specimen after neoadjuvant chemotherapy is also considered as the achievement of pathologic complete response.
Measured: 26 weeks after the first administration of neoadjuvant chemotherapy with doxorubicin/cyclophosphamide regimens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startApr 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660542
- Sponsor's protocol ID
- 4-2011-0068
- Status last verified
- Oct 2016
- First submitted
- 5 Aug 2012
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Phase Ⅳ Trial to Evaluate the Efficacy and Safety of Sequential Neoadjuvant Chemotherapy With Docetaxel(Monotaxel®) After Doxorubicin Plus Cyclophosphamide Combination Chemotherapy in Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01660542
- Acronym / sponsor ID
- 4-2011-0068
- Conditions
- Locally Advanced Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Aug 2012 (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 is a multicenter, open-label, phase IV trial to assess the efficacy and safety of sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by 4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or cytologically confirmed axillary lymph nodes metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| doxorubicin/cyclophosphamide | Experimental | Drug: Neoadjuvant Chemotherapy with DocetaxelNeoadjuvant Chemotherapy with Docetaxel(Monotaxel®) after Doxorubicin plus Cyclophosphamide |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically proven invasive breast cancer - the primary tumor size is at least 5cm or cytologically proven axillary node metastasis
- no evidence of systemic metastasis pathologically or radiologically
- age at the time of diagnosis between 20 and 70 years
- patients with previously untreated primary breast cancer including chemotherapy
- general performance status with ECOG 0-2
Key exclusion criteria (8 listed)
- patients with evidence of distant metastases
- patients with other previous malignancy except breast cancer
- pregnant (positive hCG test 1 week before registration) or lactating patient
- uncontrolled serious infection
- patients with psychiatric disease or epilepsy
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 |
|---|---|---|
| Neoadjuvant Chemotherapy with DocetaxelDoxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 (day 1), IV (in the vein), every 21 days, a total of 4 cycles -> Docetaxel 100 mg/m2 (day 1) IV, every 21 days, a total of 4 cycles | Drug | doxorubicin/cyclophosphamide |
Primary outcome
Pathologic Complete Response
Time frame: 26 weeks after the first administration of neoadjuvant chemotherapy with doxorubicin/cyclophosphamide regimens
Pathologic complete response is defined as the disappearance of all invasive cancer in the postsurgical breast and lymph node specimens after completion of neoadjuvant chemotherapy. Only residual intraductal carcinoma in the postsurgical breast specimen after neoadjuvant chemotherapy is also considered as the achievement of pathologic complete response.
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 1 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neoadjuvant Chemotherapy with Docetaxel in people with Locally Advanced Breast Cancer, run by Yonsei University 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 8 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 1 Nov 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 (time frame: 26 weeks after the first administration of neoadjuvant chemotherapy with doxorubicin/cyclophosphamide regimens). 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 1 Nov 2016.