Actively Recruiting

Phase 2
Age: 18Years - 70Years
FEMALE
NCT06458413

Utidelone Capsule Plus Capecitabine (CAP) for Metastatic Breast Cancer

Led by Min Yan, MD · Updated on 2024-06-13

40

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

M

Min Yan, MD

Lead Sponsor

B

Beijing Biostar Pharmaceuticals Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study aims to investigate the efficacy and safety of utidelone capsule plus Capecitabine in the treatment of advanced breast cancer , and thus provides a new systemic treatment strategy for those patients. This study was a single-arm, phase II study of patients with recurrent or metastatic HER2-negative breast cancer who had previously received chemotherapy regimens containing taxanes and/or anthracyclines were treated with a combination of utidelone capsules and capecitabine. The main objective was to explore the efficacy and safety of the combined regimen.

CONDITIONS

Official Title

Utidelone Capsule Plus Capecitabine (CAP) for Metastatic Breast Cancer

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants aged 18 to 70 years with an ECOG performance status of 0-1 and expected survival of at least 12 weeks
  • Pathological or cytological diagnosis of HER2-negative recurrent or metastatic breast cancer, regardless of hormone receptor status
  • Previous treatment with at least paclitaxel and/or anthracycline chemotherapy
  • Prior treatment lines not exceeding 3, with specific criteria for counting lines after neoadjuvant/adjuvant therapy
  • For HR+/HER2- breast cancer, prior systemic CDK4/6 inhibitor plus endocrine therapy before progression
  • At least one measurable extracranial lesion according to RECIST 1.1
  • Normal blood routine tests within one week before enrollment, including neutrophils ≥1.5 x 10^9/L, platelets ≥90 x 10^9/L, hemoglobin ≥9.0 g/dL
  • Normal blood biochemistry within one week before enrollment, including total bilirubin ≤1.5 x ULN, liver enzymes ≤3 x ULN (or ≤5 x ULN if liver metastasis), creatinine clearance ≥50 ml/min
  • No major organ dysfunction
  • Women of childbearing potential must use effective contraception during the study and for 6 months after, and have a negative pregnancy test before enrollment
Not Eligible

You will not qualify if you...

  • History of other malignant tumors within 5 years prior to enrollment, except certain cured cancers
  • Receipt of systemic anti-tumor therapy within 2 weeks before enrollment
  • Chemotherapy, targeted therapy, immunotherapy, investigational drugs, radiation, major surgery, or significant trauma within 4 weeks before enrollment
  • Treatment with nitroso urea or mitomycin C within 6 weeks before enrollment
  • Previous treatment with Utidelone injection
  • Peripheral neuropathy grade ≥2 per CTCAE 5.0
  • Prior treatment with capecitabine or 5-fluorouracil within 12 months, except relapse after 12 months
  • Pregnant or lactating women
  • Unresolved adverse reactions from previous anti-tumor treatments above grade 1 (except hair loss without safety risk)
  • Presence of meningeal metastasis or uncontrolled brain or bone metastases
  • Uncontrolled pleural, pericardial, or abdominal effusions
  • Active infections requiring systemic treatment
  • History of immunodeficiency or organ transplantation
  • Active hepatitis B or C or known active syphilis
  • Severe cardiovascular or cerebrovascular diseases or uncontrolled hypertension
  • Uncontrolled diabetes
  • Active gastrointestinal ulcers
  • History of neurological or psychiatric disorders including epilepsy or dementia
  • Current participation in another clinical trial or use of investigational treatments
  • Known allergy to the investigational drug or excipients
  • Other serious systemic diseases or conditions making participation unsuitable as judged by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Henan Cancer hospital

Zhengzhou, Henan, China

Actively Recruiting

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Research Team

M

Min Yan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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