Clinical Study of UTD1 Injection in Combination With Capecitabine in Patients With Advanced and Metastatic Breast Cancer

NCT ID: NCT02253459

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 405 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2018-12-15

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UTD1 Injection plus capecitabine

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.

Group Type: EXPERIMENTAL

UTD1 Injection plus capecitabine

Intervention Type: DRUG

capecitabine

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.

Group Type: ACTIVE_COMPARATOR

Capecitabine

Intervention Type: DRUG

Interventions

UTD1 Injection plus capecitabine

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically and/or cytologically diagnosed patients with advanced, metastatic breast cancer,or lacking standard therapy or being failed to or recurrent after standard therapy;

2. Patients who have previously treated with ≤4 chemotherapeutic regimes;

3. Patients who have previously treated with an anthracyclin antibiotics and a taxane;

4. Age 18 -70 years old, ECOG performance status of 0-2; Life expectancy of 3 months or more;

5. Patients with at least 1 measurable target lesion determined by CT within 2 weeks prior to enrollment;

6. Neuropathy <CTC2 degree （NCI CTC4.03）within 4 weeks prior to enrollment;

7. Basically normal results from routine blood test within 1 week prior to enrollment;

8. Basically normal liver and renal functions within 1 week prior to enrollment;

9. No abnormal function for major internal organs, no heart diseases.

Exclusion Criteria

1. Received chemotherapy, radiotherapy, therapies with hormones or molecularly targeted drugs 4 weeks prior to enrollment, or received other chemotherapies while participating in this trial;

2. Patients with documented hypersensitivity to Cremophor EL, or patients with previous taxane treatment related SAE;

3. Patients of pregnancy or breast feeding;

4. Patients with previous standard capecitabine treatment ineffective, or patients received standard capecitabine treatment effective, but with less than 6 months of capecitabine clearance period;

5. Patients with uncontrolled brain metastasis or bone metastasis, which plan for recent surgery or local radiotherapy, or other emergency treatment;

6. 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;

7. Patients with poor compliance;

8. Patients not fitted for this study determined by the investigators.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing Biostar Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

B Xu, doctor

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

The Hospital Affiliated To Military Medical Science

Beijing, Beijing Municipality, China

The General Hospital of the People's Liberation Army

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

the First Hospital of China Medical University

Shenyang, Liaoning, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33188874 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33163394 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28209298 (View on PubMed)

Other Identifiers

BG01-1323L

Identifier Type: -

Identifier Source: org_study_id