Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+ Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The proposed study will evaluate the safety and efficacy of XRT followed by systemic therapy among patients with HER2+ metastatic breast cancer and LMD

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

• Men or women with HER2+\* metastatic breast cancer. \*HER2+ status will be defined in accordance with ASCO-CAP 2018 guidelines, and can be diagnosed at any time prior to enrolment;

• Evidence of LMD\* in the brain and/or spine (either positive cerebral spinal fluid cytology and/or magnetic resonance imaging evidence of LMD). Measurable disease in the central nervous system is not required. \* The diagnosis of LMD can occur at any time prior to enrolment;

• Age 18+ at time of consent;

• ECOG ≤ 2;

• More than 14 days or 5 half-lives from the last dose of any experimental agent is required, whichever is greater;

• All toxicity related to prior cancer therapies must have resolved to ≤ Grade 1 prior to enrollment, except for alopecia; neuropathy, must have resolved to ≤ Grade 2.

∙ Phase 2: Inclusion Criteria

• Left ventricular ejection fraction (LVEF) must be within institutional limits of normal as assessed by ECHO or MUGA documented within 2 weeks prior to starting systemic therapy on the study;

• Adequate hematologic, liver, and renal function within 2 weeks prior to phase 2 enrollment, as follows:

‣ Hemoglobin ≥ 9 g/dL

⁃ ANC ≥ 1 x109/L

⁃ Platelets ≥ 100 x109/L

⁃ Total bilirubin ≤ 1.5 X upper limit of normal (ULN)

⁃ AST and ALT ≤ 2.5X ULN

⁃ International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 X ULN

⁃ Creatinine clearance (CrCL) ≥ 50 mL/min

• The last dose of prior therapy must have been completed 14 days prior to study enrollment. Prior chemotherapy, immunotherapy, endocrine therapy, targeted therapy and experimental agents are allowed (including prior use of trastuzumab or other antibody-based therapy). Prior use of capecitabine either alone or in combination with other HER2-targeted therapies (including other tyrosine kinase inhibitors) is permitted;

Locations
Other Locations
Canada
The Ottawa Hospital
RECRUITING
Ottawa
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
CLIMB-LMD Project Manager
CLIMB-LMD@sunnybrook.ca
437-247-2617
Backup
Dr. Katarzyna Jerzak
katarzyna.jerzak@sunnybrook.ca
437-247-2617
Time Frame
Start Date: 2023-11-25
Estimated Completion Date: 2028-10-05
Participants
Target number of participants: 30
Treatments
Experimental: Tucatinib, Transtuzumab, Capecitabine
Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+ Metastatic Breast Cancer and Leptomeningeal Disease.
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre
Collaborators: Pfizer, Biocon Biologics

This content was sourced from clinicaltrials.gov

Similar Clinical Trials