UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases

Inclusion Criteria:

• Patients aged 18 to 70 years

• With histologically confirmed HER2 negative recurrent and metastatic breast cancer

• have at least one measurable lesion in the central nervous system (the longestdiameter ≥ 10mm)

• ECOG score (PS) of 0-2

• According to screening brain MRI, patients with CNS must meet the followingconditions:

1. untreated brain metastases of breast cancer;

2. do not need immediate local treatment;

3. brain metastases of breast cancer which was treated in the past:

4. There are no clinical manifestations that have progressed after theprevious local treatment of the central nervous system and requireimmediate local treatment.

5. All records related to the treatment of the central nervous system must beprovided.

6. All toxicities related to the previous anti-tumor treatment of patientswho have not received chemotherapy, radiotherapy, surgical treatment,targeted therapy and immunotherapy within 4 weeks before enrollment mustbe restored to ≤ level 1 (CTCAE v50). However, patients with hair loss ofany grade are allowed to be recruited.

• Blood routine examination was basically normal within 1 week before enrollment.

• White blood cell count (WBC) ≥ 30 × 109 /L

• Neutrophil counts (ANC) ≥ 15 × 109/L

• Platelet count (PLT) ≥ 100 × 109 /L

• Hemoglobin ≥ 90g/dl. Patients can receive blood transfusion or erythropoietintreatment to meet this standard.

• Within 1 week before enrollment, the liver and kidney function tests were basicallynormal (based on the normal value of the laboratory of each research center).

• Total bilirubin ≤ 15 × Upper limit of normal value (ULN)

• Alanine aminotransferase (SGPT / ALT) ≤ 25 x ULN (patients with liver metastasis ≤ 5 × ULN)

• Glutamic oxaloacetic transaminase (SGOT/AST) ≤ 25 × ULN (patients with livermetastasis ≤ 5 × ULN)

• Creatinine clearance rate (Ccr) ≥ 60ml/min patients

• With fertility must agree to use effective contraceptive methods during the studyperiod and within 90 days of the last study medication. Before enrollment, the bloodor urine pregnancy test must be negative and the

• Life expectancy > 12 weeks.

• The patient must be able to participate in and follow the treatment and follow-up.

Exclusion Criteria:

• Primary or metastatic lesions were HER2 positive (HER2 IHC or FISH positive)

• Other malignant carcinomas (including primary brain or leptomeningeal relatedtumors) in the past 5 years, except for the cured basal cell carcinoma of the skinand carcinoma in situ of the cervix.

• Anti tumor treatment, including chemotherapeutic radical radiotherapy, hormonetherapy, biological therapy Immunotherapy or anti-tumor traditional Chinesemedicine.

• Patients who have received surgical operation on major organs (excluding puncturebiopsy) or have suffered significant trauma within 4 weeks before the first use ofthe study drug, or who need to undergo elective surgery during the trial.

• Patients with symptomatic peripheral neuropathy with grade evaluation ≥ 2 (CTCAE 5.0), who have previously used anti-microtubule drugs and have serious adversereactions related to the nervous system of grade 3 or above.

• Use capecitabine within 6 months before enrollment; No response to capecitabine inthe past (including progression during capecitabine treatment, or duration ofclinical response after treatment < 3 months) or unable to tolerate to capecitabine.

• For any brain lesions requiring immediate local treatment, such as increased lesionsize or treatment-related edema at intracranial (but not limited to) anatomicalsites may pose risks to patients (e.g., brainstem lesions)

• Known or suspected leptomeningeal disease (LMD)

• Other non malignant systemic diseases (cardiovascular, renal, liver, etc.) that areexcluded from any treatment regimen or interfere with follow-up in pregnant orlactating women.

• Known or suspected allergy to any study drug or accessories.

• Brain MRI can not be performed for any other reason.

• The investigator considers it inappropriate to participate in.

• Other situations where corticosteroids are prohibited.