Utidelone Capsule Plus Capecitabine (CAP) for Metastatic Breast Cancer

NCT06458413 | Recruiting Phase 2

• 1 other identifier: BG02-2402
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate （ORR）

  ORR is defined as the percentage of participants in the analysis population who have CR or PR per RECIST 1.1.

  18 months

Secondary Outcomes (5)

• Progression-Free Survival（PFS）

  18 months

• Disease Control Rate （DCR）

  18 months

• Duration of response (DoR)

  18 months

• Overall survival (OS)

  18 months

• Treatment-related Adverse Event-TRAE

  Until 28 days after the last dose of treatment

Study Arms (1)

Single-arm

EXPERIMENTAL

Patients with HER2-negative breast cancer were treated with Utidelone Capsule combined with Capecitabine tablets.

Drug: Utidelone Capsule Plus Capecitabine

Interventions

Utidelone Capsule Plus Capecitabine DRUG

Utidelone Capsule: 60mg/m2/d, once daily, oral on an empty stomach, continuously administered for 1-5 days; Capecitabine tablets: 1000mg/m2, twice a day (daily dose 2000mg/m2), once in the morning and once in the evening, taken orally within 30 minutes after meals, and continuously administered for 14 days from day 1 to day 14. Every 21 days is a cycle .

Single-arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this study, sign an informed consent form, have good compliance, and are willing to follow-up.
• Female, aged ≥ 18 and ≤ 70 years, with an ECOG score of 0-1 and an expected survival time of ≥ 12 weeks.
• The pathological and/or cytological diagnosis (based on the latest biopsy results) is HER2 negative recurrent or metastatic breast cancer, regardless of hormone receptor status (ER/PR positive or negative, but the hormone receptor status needs to be determined);
• All patients have received at least paclitaxel and/or anthracycline as a treatment option;
• All patients with prior treatment ≤ 3 lines (for those who progress during the neoadjuvant/adjuvant period or within 12 months after the end of the last treatment, it is considered as the first line, and no progress is counted as the number of lines); For HR+/HER2- breast cancer patients, they also need to have received the first line systemic CDK4/6 inhibitor+endocrine therapy before the disease progresses.
• According to RECIST 1.1 standard, there is at least one measurable extracranial lesion present.
• Within one week before enrollment, the blood routine examination was basically normal (no blood transfusion within two weeks, no use of drugs to increase white blood cells or platelets):
• Neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count (PLT) ≥ 90 × 109/L; Hemoglobin ≥ 9.0 g/dL.
• Within one week before enrollment, the blood biochemistry test was basically normal (based on the normal values of each research center laboratory): Total bilirubin (TBIL) ≤ 1.5 x Upper limit of normal value (ULN) SGPT/ALT ≤ 3 × ULN (liver metastasis patients ≤ 5 × ULN); SGOT/AST ≤ 3 × ULN (liver metastasis patients ≤ 5 × ULN); The creatinine clearance rate (Ccr) is ≥ 50 ml/min (Cockcroft Gault formula).
• No major organ dysfunction
• Women with fertility must agree to use effective contraceptive methods during the study period and within 6 months after the last study medication. Women with fertility must have a negative blood or urine pregnancy test before enrollment.

You may not qualify if:

• Other malignant tumors within the 5 years prior to enrollment, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, papillary thyroid carcinoma without lymph node metastasis, or squamous cell carcinoma of the skin.
• Those who meet the following conditions:
• Received systemic anti-tumor therapy within 2 weeks prior to enrollment, including but not limited to endocrine therapy, small molecule targeted therapy, anti-tumor traditional Chinese medicine, etc;
• Within the 4 weeks prior to enrollment, chemotherapy, targeted biological therapy or immunotherapy, other clinical investigational drugs, radiation therapy, or major organ surgery (excluding biopsy) or significant trauma have been received, or elective surgery is required during the trial period. Those who have undergone major surgeries;
• Received nitroso urea or mitomycin C within 6 weeks prior to enrollment;
• Individuals who have previously received treatment with Utidelone injection.
• Peripheral neuropathy CTCAE 5.0 grade evaluation ≥ 2.
• Those who have received treatment with capecitabine or other drugs with an active ingredient of 5-fluorouracil (excluding those who relapse after more than 12 months of treatment).
• Pregnant and lactating patients.
• Adverse reactions from previous anti-tumor treatments have not yet recovered to CTCAE 5.0 grade ≤1 (excluding toxicity judged by researchers to have no safety risk for hair loss).
• Accompanied by meningeal metastasis; Accompanied by uncontrollable brain metastases (researchers have determined that new asymptomatic brain metastases or those known to have stable brain metastases after treatment can be enrolled); Or uncontrollable bone metastasis, which refers to patients who have or have recently been at risk of fractures or have obvious symptoms or other critical situations.
• Uncontrollable pleural effusion, pericardial effusion, or abdominal effusion.
• Individuals with active infections who currently require systematic anti infection treatment.
• Have a history of immunodeficiency, including HIV antibody testing positive, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
• Individuals with active hepatitis B or hepatitis C; Known active syphilis infection.

Sponsors & Collaborators

• Min Yan, MD: lead
• Beijing Biostar Pharmaceuticals Co., Ltd.: collaborator

Study Sites (1)

Henan Cancer hospital

Zhengzhou, Henan, China

RECRUITING

Central Study Contacts

Min Yan

CONTACT

+86 157 1385 7388; ym200678@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 13, 2024
• Study Start: June 5, 2024
• Primary Completion: June 5, 2025
• Study Completion: December 5, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Three years from publication
• Access Criteria: Please contact Central contact person by Email

Locations

CN (1)