Phase II Clinical Study of UTD1 in Combination with Capecitabine or UTD1 Alone in Patients with Metastatic and Locally Advanced Breast Cancer

Multi-center, Open Labelled Phase II trials of UTD1 Alone or in Combination with Capecitabine in Patients with Metastatic or Locally Advanced Breast Cancer Previously Received an Anthrocycline, or a Taxane, and or Capecitabine

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-TRC-13004205

Enrollment

Unknown

Registered

2013-08-15

Start date

2013-08-15

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic or Locally Advanced Breast Cancer

Interventions

Group A:30mg/m2/day UTD1 (administered for consecutive 5 days)+2000mg Capecitabine (administered for consecutive 14 days). Dosing is repeated every 21 days.

Group B:40mg/m2/day UTD1(administered for consecutive 5 days). Dosing is repeated every 21 days.

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced breast cancer; 2. Previously received =3 chemotherapy regimens; 3. Patients who have previously treated with an anthracycline or a taxane and/or capecitabine; 4. Patients resistant to at least one chemotherapy of anthracyclines, taxanes and capecitabine; 5. Aged 18-70 years old women, ECOG performance status of 0-2, life expectancy of 3 months or more; 6. Patients with at least one measurable target lesion; 7. Adequate organ function for heart, liver, kidney and bone narrow; 8. Peripheral neuropathy< CTC2; 9. At least 30 days of clearance since prior chemotherapy; 10. Patients with good compliance, able to understand and willing to sign the written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe or uncontrolled medical conditions, including severe cardiovascular disease, uncontrolled diabetes and high blood pressure, severe infection, liver and kidney disorders; 2. Patients in pregnant or nursing period; 3. Received any other anticancer agents or devices within 4 weeks preceding the first dose of UTD1; 4. Peripheral neuropathy= CTC2; 5. Patient with history of uncontrollable mental disease; 6. Documented hypersensitivity reaction to Cremophor EL; 7. Patients with moderate and severe liver malfunction; 8. Patients with lower compliance; 9. Patients not fitted for this study determined by the investigators.

Design outcomes

Primary

Measure	Time frame
ORR;OS;	—

Countries

China

Contacts

Public ContactBinghe Xu

Cancer Hospital of Chinese Academy of Medical Sciences

xubinghe@medmail.com.cn+86 010 87788826

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026