HER2-negative hormone-resistant inoperable or recurrent metastatic breast cancer
Conditions
Interventions
None listed
Sponsors
Kyoto Breast Cancer Research Network (KBCRN)
Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Female patients with histologically or cytologically confirmed breast cancer. 2) Patients with inoperable or recurrent metastatic breast cancer regardless of the site and number, excluding symptomatic central nervous system metastases. 3) Patients with HER2-negative disease defined as ISH negative or IHC 0, 1+ or 2+ (Those with IHC 2+ are eligible, if the additional ISH test results are negative. Those are ineligible who are with any positive results of estrogen or progesterone receptor test on primary and recurrent lesion). 4) Patients who are resistant to hormone therapy. 5) Patients with indication for the first or second line chemotherapy in HER2-negative hormone-resistant inoperable or recurrent metastatic breast cancer who scheduled to receive the chemotherapy. 6) Patients with the Eastern Cooperative Oncology Group (ECOG) performance status score 0-3 at the time of enrollment. 7) Patients with adequate bone marrow and major organ function judged by the primary physician. 8) Patients who have signed written informed consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1) Patients with symptomatic metastasis in the central nervous system. 2) Patients with a previous history of hypersensitivity to any component of drugs administered in the treatment. 3) Patients considered inappropriate for the study participation judged by the primary physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) of the first line chemotherapy from starting date of the first line chemotherapy until death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Overall survival (OS) of the second and third line chemotherapy from starting date of each chemotherapy until death from any cause 2) Progression-free survival (PFS) of the first, second and third line chemotherapy 3) Post progression survival (PPS) of the first, second and third line chemotherapy 4) Time to treatment failure (TTF) of the first, second and third line chemotherapy 5) New metastasis-free survival (nMFS) of the first, second and third line chemotherapy 6) QALY (Japanese version of the EQ-5D-5L) 7) Serious adverse events | — |
Countries
Japan
Contacts
Public ContactYuichiro Kikawa Takeshi Kotake
Kobe city medical center general hospital Kyoto University Hospital Department of Breast surgery
Outcome results
None listed