Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC

NCT03295552 | Terminated Phase 2 DMC

• 1 other identifier: RJBC1701
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of novel DNA demethylating agents in the treatment of metastatic TNBC

Conditions

Breast Neoplasm

Keywords

decitabine; triple negative breast cancer; carboplatin; metastatic

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Partial response (PR) + complete response (CR) rate

  At the end of Cycle 6 (each cycle is 21 days)

Study Arms (1)

DC

EXPERIMENTAL

DNA demethylating agent decitabine plus carboplatin

Drug: Decitabine; Drug: Carboplatin

Interventions

Decitabine DRUG

decitabine 7mg/m2, d1-d5, q3w

DC

Carboplatin DRUG

carboplatin AUC = 6, d6, q3w

DC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms; Neoplasm Metastasis

Interventions

Decitabine; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Coordination Complexes

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 28, 2017
• Study Start: November 15, 2017
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

CN (1)