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

Beijing Biostar Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: UTD1 Injection plus capecitabine; Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02253459

BG01-1323L

Details and patient eligibility

About

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.

Enrollment: 405 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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405 participants in 2 patient groups

UTD1 Injection plus capecitabine

Experimental group

Description:

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.

Treatment:

Drug: UTD1 Injection plus capecitabine

capecitabine

Active Comparator group

Description:

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.

Treatment:

Drug: Capecitabine