Table 1:

Clinical trials involving combination therapies for breast cancer brain metastases as found in ClinicalTrials.gov as of October 31, 2019 (n = 65).

	NA	Phase I	Phase I/II	Phase II	Phase III	Total
Number of Trials	1 (2%)	9 (14%)	8 (12%)	39 (60%)	8 (12%)	65 (100%)
Trial Status
Completed	-	4	-	12	3	19 (29%)
Active, not recruiting	1	2	1	7	2	13 (20%)
Recruiting	-	2	3	5	3	13 (20%)
Not yet recruiting	-	1	-	1	-	2 (3%)
Enrolling by invitation	-	-	-	-	-	-
Terminated	-	-	3	9	-	12 (18%)
Withdrawn	-	-	1	1	-	2 (3%)
Unknown status	-	-	-	4	-	4 (6%)
Estimated Enrollment
0-10	-	-	3	6	-	9 (14%)
11-50	1	8	2	22	-	33 (51%)
51-100	-	1	2	4	-	7 (11%)
>100	-	-	1	7	8	16 (25%)
BCBM Classification
Newly diagnosed/progressive	-	-	3	17	2	22 (34%)
Recurrent	-	1	-	-	-	1 (2%)
Both	-	3	3	3	1	10 (15%)
Not specified/other	1	5	2	19	5	32 (49%)
Breast Cancer Subtype
HER2 – positive	1	6	6	17	5	35 (54%)
HER2 – negative	-	-	2	-	-	2 (3%)
Triple negative (ER-, PR-, HER2-)	-	-	1	4	1	6 (9%)
Unspecified	-	3	1	18	2	24 (37%)
Required Prior Therapy
WBRT and/or SRS	-	-	2	6	-	8 (12%)
Chemotherapy	-	-	2	5	2	9 (14%)
No treatment	-	1	-	6	2	8 (12%)
No Requirement of Prior Therapy	1	8	4	22	4	39 (60%)
Results Provided	-	2	2	11	4	19 (29%)
Related Publication	-	1	1	8	3	13 (20%)
Trial Location
North America (US/Canada)	1	7	7	24	4	43 (66%)
Europe/UK/Russia	-	2	-	7	-	9 (14%)
Asia/Australia	-	-	-	6	-	6 (9%)
Intercontinental	-	-	1	2	4	7 (11%)

WBRT: whole brain radiation therapy, SRS: stereotactic radiosurgery.