Metastatic Triple Negative Breast CancerPhase 3SYSUCC-007NCT03055312
Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer
A Phase 3 study testing TPC and Bicalutamide 150 mg in people with Metastatic Triple Negative Breast Cancer, run by Sun Yat-sen University at 2 sites in China.
Trial summary
Compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic Triple Negative Breast Cancer
- What is being tested?
- TPC and Bicalutamide 150 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesChina
- Study dates
- 20 Dec 2016to 15 Nov 2020
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-70 years old, female
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Confirmed by pathology or organizing cytology AR positive(IHC：≧10%)triple negative breast cancer
- For the first time recurrence or newly diagnosed advanced breast cancer,Disease-free survival time 12 months above
- Measurable disease per RECIST version 1.1,or immeasurably lesions bone metastasis
- After Recurrence has not received cancer treatment
- Life expectancy of at least 6 months
- Signed and dated an informed consent form
Who cannot join
- ECOG score ≧2
- Only brain metastasis or meningeal metastasis
- Receiving other anti-tumor treatment
- Heart,lung,liver,kidney,bone marrow,and other functions badness
Trial locations and contacts
2 sites in 1 country.
China2 sites
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, 510060
About this study
Official title: A Randomized, Multicenter,Phase III Study of Bicalutamide Versus Chemotherapy in First Line Treatment of AR Positive Metastatic Triple Negative Breast Cancer
Compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast
Read the detailed description
This is a phase III,Multi-center,prospective,randomized clinical trials. The objective compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast cancer.Primary endpoint is 16-week clinical benefit rate (CBR).By centre randomized grouping bicalutamide (experimental Group) or TPC (Control Group).
- Conditions
- Metastatic Triple Negative Breast Cancer
- Being tested
- TPC, Bicalutamide 150 mg
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPCDrug
Also called Chemotherapy
Conventional chemotherapy(choose a):
TX:(Docetaxel 75mg/m2 iv day1 and Capecitabine 950mg/m2 po twice daily days 1-14)every 3 weeks.
GT:(Paclitaxel 175mg/m2 iv day1 and Gemcitabine 1250mg/m2 iv days 1 \& days 8)every 3 weeks.
GC:(Gemcitabine 1000mg/m2 on days 1 \& days 8 and Carboplatin by Area Under Curve (AUC) 2 iv on days 1 \& days 8) every 3 weeks
Bicalutamide 150 mgDrug
Also called Bicalutamide
Bicalutamide 150mg/day,every 28 days
| Study group | Role | What they receive |
|---|---|---|
| TPC chemotherapy | Active comparator | Conventional chemotherapy(choose a):
TX (Taxotere and Xeloda),GT (Gemcitabine and Paclitaxel),GC (Gemcitabine and Carboplatin) Receives: Drug: TPC |
| Bicalutamide | Experimental | Bicalutamide 150mg/day every 28 days Receives: Drug: Bicalutamide 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate for 16 weeks
The proportion of patients with complete response, partial response and stable disease
Measured: 16 weeks
Secondary outcomes (1)
progression-free survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start20 Dec 2016
- Primary completion15 Nov 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Triple Negative 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT03055312
- Sponsor's protocol ID
- SYSUCC-007
- Acronym
- SYSUCC-007
- Status last verified
- Jan 2021
- First submitted
- 9 Jan 2017
- Last updated
- 28 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 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter,Phase III Study of Bicalutamide Versus Chemotherapy in First Line Treatment of AR Positive Metastatic Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT03055312
- Acronym / sponsor ID
- SYSUCC-007 / SYSUCC-007
- Conditions
- Metastatic Triple Negative Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 16 Feb 2017 (actual)
- 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.
Compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast
Detailed description
This is a phase III,Multi-center,prospective,randomized clinical trials. The objective compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast cancer.Primary endpoint is 16-week clinical benefit rate (CBR).By centre randomized grouping bicalutamide (experimental Group) or TPC (Control Group).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPC chemotherapy | Active comparator | Drug: TPCConventional chemotherapy(choose a): TX (Taxotere and Xeloda),GT (Gemcitabine and Paclitaxel),GC (Gemcitabine and Carboplatin) |
| Bicalutamide | Experimental | Drug: Bicalutamide 150 mgBicalutamide 150mg/day every 28 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18-70 years old, female
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Confirmed by pathology or organizing cytology AR positive(IHC：≧10%)triple negative breast cancer
- For the first time recurrence or newly diagnosed advanced breast cancer,Disease-free survival time 12 months above
- Measurable disease per RECIST version 1.1,or immeasurably lesions bone metastasis
Key exclusion criteria (4 listed)
- ECOG score ≧2
- Only brain metastasis or meningeal metastasis
- Receiving other anti-tumor treatment
- Heart,lung,liver,kidney,bone marrow,and other functions badness
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 |
|---|---|---|
| TPCAlso: ChemotherapyConventional chemotherapy(choose a): TX:(Docetaxel 75mg/m2 iv day1 and Capecitabine 950mg/m2 po twice daily days 1-14)every 3 weeks. GT:(Paclitaxel 175mg/m2 iv day1 and Gemcitabine 1250mg/m2 iv days 1 \& days 8)every 3 weeks. GC:(Gemcitabine 1000mg/m2 on days 1 \& days 8 and Carboplatin by Area Under Curve (AUC) 2 iv on days 1 \& days 8) every 3 weeks | Drug | TPC chemotherapy |
| Bicalutamide 150 mgAlso: BicalutamideBicalutamide 150mg/day,every 28 days | Drug | Bicalutamide |
Primary outcome
Clinical benefit rate for 16 weeks
Time frame: 16 weeks
The proportion of patients with complete response, partial response and stable disease
1 secondary outcome
progression-free survival
Time frame: 24 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TPC and Bicalutamide 150 mg in people with Metastatic Triple Negative Breast Cancer, run by Sun Yat-sen University at 2 sites 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 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: stopped early, as of the sponsor's last update on 28 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 2 sites 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 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 was stopped early. 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?
Clinical benefit rate for 16 weeks (time frame: 16 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 28 Jan 2021.