Metastatic Breast CancerPhase 2NCT02362230
Evaluation of Icotinib in Metastatic Triple-negative Breast Cancer After Second-line Therapy
A Phase 2 study testing Icotinib in people with Metastatic Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Evaluating the safety and efficacy of Icotinib administered in 2-month treatments, in patients with metastatic triple-negative breast cancer that have received at least two prior treatments. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Icotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to 15 Dec 2020
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- ECOG 0 or 1
- Primary or metastatic tumor onfirmed as triple negative
- Measurable disease per RECIST version 1.1
- normal organ function, including bone marrow function, renal function, liver function, and cardiac function
- Two or more prior chemotherapy
- signed and dated an informed consent form
- Life expectancy of at least 12 weeks
Who cannot join
- Pregnant or breast feeding
- ECOG score ≧2
- Uncontrolled medical problems
- Hepatic, renal, or bone marrow dysfunction as detailed above
- Concurrent malignancy or history of other malignancy within the last five years except as noted above
- Patients were unable or unwilling to comply with program requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sun Yat-sen University Cancer Center
Evaluating the safety and efficacy of Icotinib administered in 2-month treatments, in patients with metastatic triple-negative breast cancer that have received at least two prior treatments.
Read the detailed description
This is a phase II, multi-center study. Sixty-seven patients are planned to be enrolled. All patients will receive Icotinib 125 mg BID administered for 8 weeks. Patients with a complete response, partial response or stable disease at that time may continue to be treated based on physician discretion. Follow up is then required until resolution or stabilization of any treatment-related toxicity, and patients with stable disease or objective responses must also continue evaluations until survived.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Icotinib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcotinibDrug
Also called Conmana
Icotinib 125 mg BID
| Study group | Role | What they receive |
|---|---|---|
| Icotinib | Experimental | Icotinib 125 mg BID Receives: Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
the time from randomization to the date of disease progression or death from any causes
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startJan 2015
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Why it stopped: Difficulty accruing subjects the study accrual was closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhong-yu Yuan, Sun Yat-sen University
- Investigators
- Zhong-Yu Yuan, M.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362230
- Sponsor's protocol ID
- SYSUCC-006
- Status last verified
- Jan 2021
- First submitted
- 8 Feb 2015
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sun Yat-sen University Cancer Center
- ClinicalTrials.gov ID
- NCT02362230
- Acronym / sponsor ID
- SYSUCC-006
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty accruing subjects the study accrual was closed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 12 Feb 2015 (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.
Evaluating the safety and efficacy of Icotinib administered in 2-month treatments, in patients with metastatic triple-negative breast cancer that have received at least two prior treatments.
Detailed description
This is a phase II, multi-center study. Sixty-seven patients are planned to be enrolled. All patients will receive Icotinib 125 mg BID administered for 8 weeks. Patients with a complete response, partial response or stable disease at that time may continue to be treated based on physician discretion. Follow up is then required until resolution or stabilization of any treatment-related toxicity, and patients with stable disease or objective responses must also continue evaluations until survived.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icotinib | Experimental | Drug: IcotinibIcotinib 125 mg BID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older
- ECOG 0 or 1
- Primary or metastatic tumor onfirmed as triple negative
- Measurable disease per RECIST version 1.1
- normal organ function, including bone marrow function, renal function, liver function, and cardiac function
Key exclusion criteria (6 listed)
- Pregnant or breast feeding
- ECOG score ≧2
- Uncontrolled medical problems
- Hepatic, renal, or bone marrow dysfunction as detailed above
- Concurrent malignancy or history of other malignancy within the last five years except as noted above
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 |
|---|---|---|
| IcotinibAlso: ConmanaIcotinib 125 mg BID | Drug | Icotinib |
Primary outcome
Progression Free Survival
Time frame: 36 months
the time from randomization to the date of disease progression or death from any causes
Results and safety
The study was stopped early (reason given: Difficulty accruing subjects the study accrual was closed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Zhong-Yu Yuan, M.D. principal investigator
Sun Yat-sen University
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 Icotinib in people with Metastatic Breast Cancer, run by Sun Yat-sen 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 8 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: stopped early, as of the sponsor's last update on 29 Jan 2021. 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?
The study was stopped early (reason given: Difficulty accruing subjects the study accrual was closed). Results are not available in the source record.
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?
Progression Free Survival (time frame: 36 months). 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 29 Jan 2021.