Tucatinib, Trastuzumab, and Capecitabine With SRS for Brain Metastases From HER-2 Positive Breast Cancer

Inclusion Criteria

• •1. Histologically confirmed HER-2 -positive breast cancer with newly-diagnosed brain metastases.
• •2. ECOG Performance Status (PS) of 0, 1, 2
• •3. Patients with 1-10 brain metastases will be candidates for tucatinib, capecitabine, and trastuzumab with SRS at the discretion of the treating radiation oncologist. Intra-cranial brain metastasis must measure 3 cm or less in the greatest dimension
• •4. Age 18 years or greater and being willing and able to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures
• •5. Life expectancy at least 12 weeks
• •6. Any number of prior systemic therapies will be allowed, except tucatinib and capecitabine.
• •7. Hemoglobin ≥ 9g/dL, White blood count ≥3.0 × 10\^9/ L , Absolute Granulocyte count ≥1.5x 10\^9/ L and platelet count ≥100 × 10\^9/ L.
• •8. Serum bilirubin ≤ 1.5 × ULN
• •9. AST and / or ALT \<= 2 × ULN (≤ 5 × ULN when clearly attributable to the presence of liver metastases)
• •10. Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance \> 60mL/min
• •11. Ability to comply with study procedures and monitoring
• •12. For women of childbearing potential, a negative pregnancy test should be obtained within one week prior to the start of therapy
• •13. Male or female patients of reproductive potential need to employ two highly effective and acceptable forms of contraception throughout their participation in the study and for 7 months after last dose of tucatinib, capecitabine and trastuzumab.
• •Highly effective and acceptable forms of contraception are:
• •Male condom plus spermicide
• •Cap plus spermicide
• •Diaphragm plus spermicide
• •Copper T
• •Progesterone T
• •Levonorgestrel-releasing intrauterine system (e.g., Mirena®)
• •Implants
• •Hormone shot or injection
• •Combined pill
• •Mini-pill
• •Patch
• •Postmenopausal woman on the study (that will not need contraception) is defined as:
• •Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments
• •LH and FSH levels in the postmenopausal range for women under 50
• •Radiation-induced oophorectomy with last menses \> 1 year ago
• •Chemotherapy-induced menopause with \>1 year interval since last menses
• •Surgical sterilization (bilateral oophorectomy or hysterectomy).
• •Men and women and members of all races and ethnic groups are eligible for this trial.