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

Breast Cancer Clinical Trial

Official title:

Phase III Clinical Trials of UTD1 Injection Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced and Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253459
• Other study ID #: BG01-1323L
• Status: Completed
• Phase: Phase 3
• Start date: August 2014
• Est. completion date: December 15, 2018

Study information

• Verified date: April 2019
• Source: Beijing Biostar Technologies, Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: December 15, 2018
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• UTD1 Injection plus capecitabine

• Capecitabine

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	The General Hospital of the People's Liberation Army	Beijing	Beijing
China	The Hospital Affiliated To Military Medical Science	Beijing	Beijing
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning
China	the First Hospital of China Medical University	Shenyang	Liaoning
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Biostar Technologies, Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progresssion free survival (PFS)		2.0 years
Secondary	Overall survival (OS)		4 years
Secondary	Objective Response Rate(ORR)		1.5 years