Standard-treatment-resistant metastatic breast cancer
Conditions
Interventions
Mitomycin C (MMC) plus Methotrexate (MTX) combination therapy will be administered for HRD-positive, standard-treatment-resistant metastatic breast cancer.
Mitomycin C (MMC) plus Methotrexate (MTX) combination therapy
Sponsors
Tanabe Masahiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients histologically diagnosed with breast cancer (regardless of breast cancer subtype). (2) Patients determined to be HRD-positive or suspected of having HRD due to abnormalities in homologous recombination repair-related genes, based on cancer gene panel testing or other somatic gene testing (Patients whose tumors are determined by the institutional Expert Panel to be HRD-positive or potentially HRD-associated, and for whom HRD-targeted agents or related clinical trials have been recommended) (3) Patients with at least one measurable lesion (metastatic or recurrent) based on RECIST v1.1 However, if bone metastases are not measurable, they will be evaluated by osteoblastic findings. (4) Patients who have shown resistance to standard treatments defined in the Breast Cancer Clinical Practice Guidelines (5) Patients aged >= 18 years and = 4,000 /micro L - Hemoglobin: >= 9 g/dL - Neutrophil count: >= 2,000 /micro L - Platelet count: >= 100,000 /micro L - Serum creatinine: <= 1.5 mg/dL - Total bilirubin: <= 1.5 mg/dL - AST, ALT: <= 3 times the upper limit of normal (ULN) (9) Patients who have provided written informed consent of their own free will after receiving a full explanation regarding participation in this study and fully understanding it (10) Patients capable of outpatient visits according to the study schedule
Exclusion criteria
Exclusion criteria: (1) Patients with active infections (2) Patients with interstitial lung disease (3) Patients with life-threatening pleural effusion or ascites (4) Patients with a history of severe hypersensitivity to the components of the study drug (5) Patients who are pregnant or possibly pregnant (6) Breastfeeding patients (7) Any other patients deemed ineligible for participation in this study by the Principal Investigator or Sub-Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate based on RECIST v1.1 evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Frequency of adverse events (2) Progression-Free Survival (PFS) (3) Progression-Free Survival rate (4) Overall Survival rate (5) Overall Survival (OS) (6) Disease Control Rate (DCR) (7) Subgroup analysis based on homologous recombination deficiency-related gene mutations and prior treatment history | — |
Contacts
Public ContactMasahiko Tanabe
The University of Tokyo Hospital
Outcome results
None listed