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Utidelone Capsule Plus Capecitabine (CAP) for Metastatic Breast Cancer

ConditionBreast Cancer Recurrent
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorMin Yan, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 .

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Single-armExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
18 months

Secondary outcomes

1

Progression-Free Survival（PFS）

time from the first dose to disease progression or any-cause death

Time frame
18 months
2

Disease Control Rate （DCR）

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

Time frame
18 months
3

Duration of response (DoR)

DOR is defined as the interval from response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first.

Time frame
18 months
4

Overall survival (OS)

time from the first dose of study drug to any-cause death

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Min Yan, MD

Lead sponsor

Henan Cancer Hospital

Sponsor institution

Beijing Biostar Pharmaceuticals Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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