Breast NeoplasmPhase 2DETECTNCT03295552
Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC
A Phase 2 study testing Decitabine and Carboplatin in people with Breast Neoplasm, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To evaluate the effect of novel DNA demethylating agents in the treatment of metastatic TNBC Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Decitabine and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2017to 1 Jun 2021
- 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
- Female aged between 18 years and 70 years old.
- Pathologically confirmed metastatic triple negative breast cancer (TNBC). Paraffin-embedded tissue were available from metastatic or primary sites to confirm its TNBC status or for further translational research. TNBC was defined as ER-, PR-, and HER2-.
- Metastatic TNBC should not be treated with more than 1-line for metastatic disease.
- Patients can not be treated with carboplatin in the metastatic setting.
- For patients received carboplatin treatment in the adjuvant setting, they should have at least one year disease interval between last dosage of carboplatin and trial recruiting.
- Patients had at least one measurable lesion according to RECIST criteria version 1.1.
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- ECOG Performance Status (PS) of 0-1.
- Adequate liver and renal organ function.
- Dated and signed IEC/IRB-approved informed consent.
Who cannot join
- More than 1 one therapy for metastatic TNBC, Patients may receive bisphosphonates and other therapies to treat bone metastases.
- Less than four weeks since last radiotherapy.
- Pregnancy or lactation or unwillingness to use adequate method of birth control.
- Active or uncontrolled infection.
- Hypersensitivity to carboplatin or decitabine
- Male breast cancer.
- Treated with any DNA demethylating agents
- Young patients with pregnancy or lactation or unwillingness to use adequate method of birth control.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Decitabine Plus Carboplatin in the Treatment of Metastatic Triple Negative Breast Cancer
To evaluate the effect of novel DNA demethylating agents in the treatment of metastatic TNBC
- Conditions
- Breast Neoplasm
- Being tested
- Decitabine, Carboplatin
- Keywords
- decitabine, triple negative breast cancer, carboplatin, metastatic
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
decitabine 7mg/m2, d1-d5, q3w
CarboplatinDrug
carboplatin AUC = 6, d6, q3w
| Study group | Role | What they receive |
|---|---|---|
| DC | Experimental | DNA demethylating agent decitabine plus carboplatin Receives: Drug: Decitabine; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Partial response (PR) + complete response (CR) rate
Measured: At the end of Cycle 6 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start15 Nov 2017
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Why it stopped: Slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunwei Shen, Shanghai Jiao Tong University School of Medicine
- Investigators
- Kunwei Shen, MD, Principal investigator, Ruijin Hospital, Shanghai Jiaotong Univeristy School of MedicineMin Lu, PHD, Principal investigator, Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295552
- Sponsor's protocol ID
- RJBC1701
- Acronym
- DETECT
- Status last verified
- Mar 2022
- First submitted
- 20 Sep 2017
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decitabine Plus Carboplatin in the Treatment of Metastatic Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT03295552
- Acronym / sponsor ID
- DETECT / RJBC1701
- Conditions
- Breast Neoplasm
- Keywords
- decitabine, triple negative breast cancer, carboplatin, metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 28 Sep 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.
To evaluate the effect of novel DNA demethylating agents in the treatment of metastatic TNBC
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DC | Experimental | Drug: Decitabine, Drug: CarboplatinDNA demethylating agent decitabine plus carboplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female aged between 18 years and 70 years old.
- Pathologically confirmed metastatic triple negative breast cancer (TNBC). Paraffin-embedded tissue were available from metastatic or primary sites to confirm its TNBC status or for further translational research. TNBC was defined as ER-, PR-, and HER2-.
- Metastatic TNBC should not be treated with more than 1-line for metastatic disease.
- Patients can not be treated with carboplatin in the metastatic setting.
- For patients received carboplatin treatment in the adjuvant setting, they should have at least one year disease interval between last dosage of carboplatin and trial recruiting.
Key exclusion criteria (8 listed)
- More than 1 one therapy for metastatic TNBC, Patients may receive bisphosphonates and other therapies to treat bone metastases.
- Less than four weeks since last radiotherapy.
- Pregnancy or lactation or unwillingness to use adequate method of birth control.
- Active or uncontrolled infection.
- Hypersensitivity to carboplatin or decitabine
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 |
|---|---|---|
| Decitabinedecitabine 7mg/m2, d1-d5, q3w | Drug | DC |
| Carboplatincarboplatin AUC = 6, d6, q3w | Drug | DC |
Primary outcome
Overall response rate
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Partial response (PR) + complete response (CR) rate
Results and safety
The study was stopped early (reason given: Slow enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Kunwei Shen, MD principal investigator
Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine
Min Lu, PHD principal investigator
Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine
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 Decitabine and Carboplatin in people with Breast Neoplasm, run by Shanghai Jiao Tong University School of Medicine 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 9 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: stopped early, as of the sponsor's last update on 6 Apr 2022. 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: Slow enrollment.). 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?
Overall response rate (time frame: At the end of Cycle 6 (each cycle is 21 days)). 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 6 Apr 2022.