NCT02253459

Brief Summary

The purpose of this study is to determine whether UTD1 Injection in combination with capecitabine is effective in the treatment of advanced metastatic breast cancer using capecitabine as a control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
405

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

2.1 years

First QC Date

September 29, 2014

Last Update Submit

April 5, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progresssion free survival (PFS)

    2.0 years

Secondary Outcomes (2)

  • Overall survival (OS)

    4 years

  • Objective Response Rate(ORR）

    1.5 years

Study Arms (2)

UTD1 Injection plus capecitabine

EXPERIMENTAL

UTD1 Injection: 30 mg/m2/day, IV on day 1-day 5 of each 21 day cycle; Capecitabine: 2000 mg/m2/day, oral bid on day 1-day 14 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Drug: UTD1 Injection plus capecitabine

capecitabine

ACTIVE COMPARATOR

Capecitabine: 2500 mg/m2/day, oral bid on day 1-day 14 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Drug: Capecitabine

Interventions

UTD1 Injection plus capecitabineDRUG
UTD1 Injection plus capecitabine
CapecitabineDRUG
capecitabine

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically and/or cytologically diagnosed patients with advanced, metastatic breast cancer,or lacking standard therapy or being failed to or recurrent after standard therapy;
  • Patients who have previously treated with ≤4 chemotherapeutic regimes;
  • Patients who have previously treated with an anthracyclin antibiotics and a taxane;
  • Age 18 -70 years old, ECOG performance status of 0-2; Life expectancy of 3 months or more;
  • Patients with at least 1 measurable target lesion determined by CT within 2 weeks prior to enrollment;
  • Neuropathy \<CTC2 degree （NCI CTC4.03）within 4 weeks prior to enrollment;
  • Basically normal results from routine blood test within 1 week prior to enrollment;
  • Basically normal liver and renal functions within 1 week prior to enrollment;
  • No abnormal function for major internal organs, no heart diseases.

You may not qualify if:

  • Received chemotherapy, radiotherapy, therapies with hormones or molecularly targeted drugs 4 weeks prior to enrollment, or received other chemotherapies while participating in this trial;
  • Patients with documented hypersensitivity to Cremophor EL, or patients with previous taxane treatment related SAE;
  • Patients of pregnancy or breast feeding;
  • Patients with previous standard capecitabine treatment ineffective, or patients received standard capecitabine treatment effective, but with less than 6 months of capecitabine clearance period;
  • Patients with uncontrolled brain metastasis or bone metastasis, which plan for recent surgery or local radiotherapy, or other emergency treatment;
  • Patients combined with severe and /or uncontrolled medical conditions, including severe cardiovascular disease, uncontrolled diabetes and high blood pressure, severe infection, severe gastrointestinal ulceration, and patients with incontrollable psychiatric history;
  • Patients with poor compliance;
  • Patients not fitted for this study determined by the investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

The Hospital Affiliated To Military Medical Science

Beijing, Beijing Municipality, 100071, China

Location

The General Hospital of the People's Liberation Army

Beijing, Beijing Municipality, 100853, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110042, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200433, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (3)

  • Xu B, Sun T, Zhang Q, Zhang P, Yuan Z, Jiang Z, Wang X, Cui S, Teng Y, Hu XC, Yang J, Pan H, Tong Z, Li H, Yao Q, Wang Y, Yin Y, Sun P, Zheng H, Cheng J, Lu J, Zhang B, Geng C, Liu J, Shen K, Yu S, Li H, Tang L, Qiu R; study group of BG01-1323L. Efficacy of utidelone plus capecitabine versus capecitabine for heavily pretreated, anthracycline- and taxane-refractory metastatic breast cancer: final analysis of overall survival in a phase III randomised controlled trial. Ann Oncol. 2021 Feb;32(2):218-228. doi: 10.1016/j.annonc.2020.10.600. Epub 2020 Nov 11.

    PMID: 33188874DERIVED

  • Xu J, Wang Y, Jiang C, Cao H, Jiang J, Xu B, Sun T. Ganglioside Monosialic Acid Alleviates Peripheral Neuropathy Induced by Utidelone Plus Capecitabine in Metastatic Breast Cancer From a Phase III Clinical Trial. Front Oncol. 2020 Oct 9;10:524223. doi: 10.3389/fonc.2020.524223. eCollection 2020.

    PMID: 33163394DERIVED

  • Zhang P, Sun T, Zhang Q, Yuan Z, Jiang Z, Wang XJ, Cui S, Teng Y, Hu XC, Yang J, Pan H, Tong Z, Li H, Yao Q, Wang Y, Yin Y, Sun P, Zheng H, Cheng J, Lu J, Zhang B, Geng C, Liu J, Peng R, Yan M, Zhang S, Huang J, Tang L, Qiu R, Xu B; BG01-1323L study group. Utidelone plus capecitabine versus capecitabine alone for heavily pretreated metastatic breast cancer refractory to anthracyclines and taxanes: a multicentre, open-label, superiority, phase 3, randomised controlled trial. Lancet Oncol. 2017 Mar;18(3):371-383. doi: 10.1016/S1470-2045(17)30088-8. Epub 2017 Feb 11.

    PMID: 28209298DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • B Xu, doctor

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 1, 2014

Study Start

August 1, 2014

Primary Completion

September 1, 2016

Study Completion

December 15, 2018

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations

CN(11)