Table 4. Reasons for ineligibility for the ACTION trial.

	Screening data received before June 2008		Screening data received between June 2008 and local R&D approval		Screening data received after local R&D approval		Total
	n	%	n	%	n	%	n	%
Number of ineligible patients	248	100	73	100	125	100	446	100
Low risk ER+/Allred or quick score >5	126	50.8	33	45.2	43	34.4	202	45.3
Previous invasive cancer/metastatic disease	39 (metastatic=6)	15.7	9 (metastatic=1)	12.3	14 (metastatic=2)	11.2	62 (metastatic=9)	13.9
Not fit enough to receive trial chemotherapy	23	9.3	12	16.4	20	16	55	12.3
HER2 positive	18	7.3	0	0	0	0	18	4
Did not have surgery	4	1.6	2	2.7	9	7.2	15	3.4
Inoperable breast cancer	4	1.6	3	4.1	0	0	7	1.6
Significant cardiac disease	4	1.6	2	2.7	1	0.8	7	1.6
Previous systemic therapy	0	0	0	0	5	4	5	1.1
Unable to give informed consent	2	0.8	1	1.4	0	0	3	0.7
More than 8 weeks since surgery	2	0.8	0	0	0	0	2	0.4
Other	26	10.5	11	15.1	33	26.4	70	15.7
Investigator decision – not to give chemotherapy	6	2.4	6	8.2	7	5.6	19	4.3
DCIS	6	2.4	0	0	4	3.2	10	2.2
Benign disease	4	1.6	0	0	2	1.6	6	1.3
Further surgery required	2	0.8	1	1.4	2	1.6	5	1.1
Investigator decision – to give chemotherapy	4	1.6	0	0	0	0	4	0.9
Patient did not want active treatment	0	0	1	1.4	1	0.8	2	0.4
Neoadjuvant chemotherapy given	0	0	0	0	2	1.6	2	0.4
No axillary surgery	1	0.4	0	0	0	0	1	0.2
Investigator decision – not otherwise specified	0	0	0	0	1	0.8	1	0.2
Paget's disease of nipple only	0	0	1	1.4	0	0	1	0.2
Bilateral breast cancer	0	0	0	0	1	0.8	1	0.2
Pathology implies lymphoma	0	0	0	0	1	0.8	1	0.2
Node-negative disease	0	0	0	0	1	0.8	1	0.2
Patient did not attend clinic	0	0	1	1.4	0	0	1	0.2
Patient did not want to go in any clinical trial	0	0	1	1.4	0	0	1	0.2
Patient in another trial	0	0	0	0	1	0.8	1	0.2
Awaiting test results	1	0.4	0	0	0	0	1	0.2
Unknown	2	0.8	0	0	10	8	12	2.7

Abbreviations: ER=oestrogen receptor; R&D=research and development committee.