HR-positive, HER2-negative metastatic or recurrent breast cancer
Conditions
Sponsors
Toshimi Takano (Coordinating Investigator)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed invasive breast cancer 2.Estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive 3.Human epidermal growth factor receptor 2 (HER2)-negative 4.Locally advanced or metastatic breast cancer, not amenable to resection or radiation therapy with curative intent 5.Patients with measurable lesions based on RECIST ver1.1 6.For letrozole cohort: without endocrine therapy For fulvestrant cohort: disease progression while receiving adjuvant endocrine therapy within 12 months from completion of adjuvant endocrine therapy, or disease progression or intolerance with one regimen of endocrine therapy for metastatic disease 7.Patients without treatment history with anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, anti-CTLA-4 antibodies or other T-cell co-stimulatory receptors, cytotoxic drugs except perioperative therapy, molecular target agents, such as everolimus, CDK4/6 inhibitors, PI3K inhibitors, fulvestrant 8.ECOG PS 0 or 1
Exclusion criteria
Exclusion criteria: 1.Patients with a history of infiltrative malignancy within the last 3 years 2.Patients received a live vaccine within 30 days 3.Patients required treatment with systematic corticosteroids at a predonine equivalent dose of > 10mg/day or immunosuppressive drugs 4.Patients with active infection requiring intravenous systemic treatment 5.Patients with concurrent interstitial lung disease/ pneumonitis or a history of interstitial lung disease/ pneumonitis requiring treatment with systemic corticosteroids 6.Patients who are pregnant, possibly pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Overall response rate (ORR) ORR will be assessed according to RECIST version 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy DCR and PFS will be assessed based on RECIST version 1.1 and CTCAE will be used for safety assessment and so on. | — |
Countries
Japan
Outcome results
None listed