Table 5.

Clinical Breast Examination clinical trials

Age group (years)	Study years	Design and Setting	Protocol	Primary outcome	Secondary outcome	Result and reference
35-64	1996-1997 first round screening	RCT; block randomization; Manila, Philippines; 202 health centers in 12 municipalities	MAMMACARE instruction; Annual CBE x 5 versus nurse/midwife usual practice	No breast cancer mortality reported	Relative risk not calculated due to limited (35%) diagnostic testing after positive CBE	Inconclusive; low overall study participation (“refractory attitude” amongst study subjects) with frequent drop outs after 1st round of screening; Sensitivity=26% and Positive Predictive Value=1% of screening program; Screen detected cases were not more advanced than others 40
39-65	2000-2002 (Pilot); RCT enrolling	RCT; block randomization; Italian Hospital region, Cairo, Egypt	CBE training locally 2 months before trial; CBE/BSE x 2 versus CBE/SBE x1 by female physician	Breast cancer incidence	Benign biopsies: 1.2% after 1st round	High rate of 1st and 2nd round breast cancer detection rate: 8/1,000 and 2/1,000; Study in progress 41
35-64	1998 -; RCT enrolling	RCT; cluster randomization; Mumbai, India	CBE training x 5 months before trial; CBE/BSE/Breast health education every 24 months x4 versus education alone delivered by well woman health workers	Breast cancer mortality	Not available	Study in progress 42