Decitabine Plus Carboplatin in the Treatment of Metastati... | NCT03295552

Studies
Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC

NCT03295552

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Terminated

Last Update Posted

Apr 6, 2022Actual

Enrollment

12Actual

Phase

Phase 2

Conditions

Breast Neoplasm

Interventions

Decitabine
Carboplatin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow enrollment.

Expanded Access Info

Start Date

Nov 15, 2017Actual

Primary Completion Date

Jun 1, 2021Actual

Completion Date

Jun 1, 2021Actual

First Submitted Date

Sep 20, 2017

First Submission Date that Met QC Criteria

Sep 24, 2017

First Posted Date

Sep 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2022

Last Update Posted Date

Apr 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DC	Experimental	DNA demethylating agent decitabine plus carboplatin	Drug: Decitabine Drug: Carboplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Decitabine	Drug	decitabine 7mg/m2, d1-d5, q3w	DC
Carboplatin

Measure	Description	Time Frame
Overall response rate	Partial response (PR) + complete response (CR) rate	At the end of Cycle 6 (each cycle is 21 days)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
ECOG Performance Status (PS) of 0-1.
Adequate liver and renal organ function.
Dated and signed IEC/IRB-approved informed consent.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kunwei Shen, MD	Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine	Principal Investigator
Min Lu, PHD	Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruijin Hospital, Shanghai Jiaotong University School of Medicine		Shanghai	Shanghai Municipality	200025	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D064726	Triple Negative Breast Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D001374	Azacitidine
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine