Phase 1 Trial of Tucatinib, Trastuzumab, and Capecitabine With Stereotactic Radiosurgery (SRS) in Patients With Brain Metastases From HER-2 Positive Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This research study will evaluate how well brain metastases associated with HER-2 positive breast cancer can be controlled using a type of radiation known as stereotactic radiosurgery (SRS) when combined with three therapeutic agents, tucatinib, capecitabine, and trastuzumab. The combined use of SRS with the three drugs is considered investigational.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Histologically confirmed HER-2 -positive breast cancer with newly-diagnosed brain metastases.

⁃ ECOG Performance Status (PS) of 0, 1, 2

⁃ 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

⁃ 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

⁃ Life expectancy at least 12 weeks

⁃ Any number of prior systemic therapies will be allowed, except tucatinib and capecitabine.

⁃ 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.

⁃ Serum bilirubin ≤ 1.5 × ULN

⁃ AST and / or ALT \<= 2 × ULN (≤ 5 × ULN when clearly attributable to the presence of liver metastases)

‣ Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance \> 60mL/min

‣ Ability to comply with study procedures and monitoring

‣ For women of childbearing potential, a negative pregnancy test should be obtained within one week prior to the start of therapy

‣ 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.

Locations
United States
Florida
Miami Cancer Institute at Baptist Health, Inc.
RECRUITING
Miami
Contact Information
Primary
Manmeet Ahluwalia, M.D., MBA
manmeeta@baptisthealth.net
(786) 596-2000
Backup
Daylen Santana
daylens@baptisthealth.net
(786) 596-2000
Time Frame
Start Date: 2024-01-29
Estimated Completion Date: 2029-02
Participants
Target number of participants: 40
Treatments
Experimental: Investigational Treatment
Related Therapeutic Areas
Sponsors
Collaborators: Pfizer
Leads: Baptist Health South Florida

This content was sourced from clinicaltrials.gov

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