Carcinoma Breast Stage IVPhase 2NCT02183805
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Metastatic Triple-negative Breast Cancer
A Phase 2 study testing Abraxane,Cyclophosphamide,Carboplatin in people with Carcinoma Breast Stage IV, run by Sun Yat-sen University at 1 site in China.
Trial summary
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Carcinoma Breast Stage IV
- What is being tested?
- Abraxane,Cyclophosphamide,Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2014to 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) 0 or 1.
- Histologically or cytologically proven diagnosis of breast cancer with evidence of locally recurrent or metastatic disease.
- Documentation of estrogen and progestin receptor (ER/PR) negative status and HER2/neu receptor negative status (ie, FISH negative or immunohistochemistry 0 or +1).
- Obtained complete response or Good partial response after first line chemotherapy.
- Normal organ function required prior to study entry.
- Willingness to comply with treatment plans and other study procedures.
Who cannot join
- Uncontrolled central nervous system (CNS) involvement with disease
- Fertile women unwilling to use contraceptive techniques during treatment
- Females who are pregnant
- Organ dysfunction.
- Patients may not be receiving any other investigational agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Chemotherapy Followed by Peripheral Stem Cell Transplantation as First Line Therapy for Metastatic Triple-negative Breast Cancer
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
Read the detailed description
To explore the progression-free survival of patients with metastatic triple-negative breast cancer treated with peripheral blood stem cell transplant (PBSCT) followed by high dose chemotherapy.
- Conditions
- Carcinoma Breast Stage IV
- Being tested
- Abraxane,Cyclophosphamide,Carboplatin
- Keywords
- triple negative breast cancer, autologous hematopoietic stem-cell transplantation
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abraxane,Cyclophosphamide,CarboplatinDrug
Also called Abraxane 800 mg/m2, Cyclophosphamide 3g/m2, Carboplatin 800 mg/m2
High dose chemotherapy: Abraxane, Cyclophosphamide, Carboplatin
| Study group | Role | What they receive |
|---|---|---|
| Metastatic triple negative breast cancer | Experimental | Abraxane,Cyclophosphamide,Carboplatin Receives: Drug: Abraxane,Cyclophosphamide,Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free Survival
Measured: 24 months
Secondary outcomes (1)
Overall 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 posted8 Jul 2014 (estimated)
- Study start17 Jun 2014
- 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 Carcinoma Breast Stage IVStudies 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
- 6 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
- NCT02183805
- Sponsor's protocol ID
- SYSUCC-004
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2014
- Last updated
- 23 Jul 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 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Chemotherapy Followed by Peripheral Stem Cell Transplantation as First Line Therapy for Metastatic Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT02183805
- Acronym / sponsor ID
- SYSUCC-004
- Conditions
- Carcinoma Breast Stage IV
- Keywords
- triple negative breast cancer, autologous hematopoietic stem-cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty accruing subjects the study accrual was closed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 17 Jun 2014 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 8 Jul 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.
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
Detailed description
To explore the progression-free survival of patients with metastatic triple-negative breast cancer treated with peripheral blood stem cell transplant (PBSCT) followed by high dose chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic triple negative breast cancer | Experimental | Drug: Abraxane,Cyclophosphamide,CarboplatinAbraxane,Cyclophosphamide,Carboplatin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eastern Cooperative Oncology Group (ECOG) 0 or 1.
- Histologically or cytologically proven diagnosis of breast cancer with evidence of locally recurrent or metastatic disease.
- Documentation of estrogen and progestin receptor (ER/PR) negative status and HER2/neu receptor negative status (ie, FISH negative or immunohistochemistry 0 or +1).
- Obtained complete response or Good partial response after first line chemotherapy.
- Normal organ function required prior to study entry.
Key exclusion criteria (5 listed)
- Uncontrolled central nervous system (CNS) involvement with disease
- Fertile women unwilling to use contraceptive techniques during treatment
- Females who are pregnant
- Organ dysfunction.
- Patients may not be receiving any other investigational agents.
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 |
|---|---|---|
| Abraxane,Cyclophosphamide,CarboplatinAlso: Abraxane 800 mg/m2, Cyclophosphamide 3g/m2, Carboplatin 800 mg/m2High dose chemotherapy: Abraxane, Cyclophosphamide, Carboplatin | Drug | Metastatic triple negative breast cancer |
Primary outcome
Progression free Survival
Time frame: 24 months
1 secondary outcome
Overall Survival
Time frame: 24 months
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 23 Jul 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 Abraxane,Cyclophosphamide,Carboplatin in people with Carcinoma Breast Stage IV, 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 6 inclusion and 5 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 23 Jul 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: 24 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 23 Jul 2021.