Table 2.

Specific and common eligibility criteria for physical activity and weight control trials addressing breast cancer risk and survival^*

Criteria	Primary prevention	Survival	Common to both
Inclusion	Age 45–75 years†	Up to age 75 years	Female
	Postmenopausal‡	Breast cancer diagnosis	All races and ethnicities§
	High risk for breast cancer (using  Gail model for risk)	Completion of treatment	Medical clearance‖
			BMI of ≥24 kg/m2 (≥23 kg/m2 for Asians) but ≤45 kg/m2¶
Exclusion	Invasive breast cancer	Pending systemic treatment  decision	Cardiovascular disease#
	Diagnosis of DCIS
	Use of SERMs
			Insulin-dependent diabetes
			Current weight-loss medication or surgical procedure
			Recent weight loss of ≥10 pounds or enrollment in  active weight-loss program
			Factors potentially limiting intervention adherence:
			Other medical contraindication
			Mental illness
			Substantial travel time to intervention site

^*Items in the “Primary prevention” column are relevant only to that trial, items in the “Survival” column are relevant only to that trial; items in the column labeled “Common to both” are relevant to both trials. BMI = body mass index; DCIS = ductal carcinoma in situ; SERMs = selective estrogen receptor modulators.

^†The upper age limit of 75 years was selected to identify women with an expected lifespan of 5 or more years and the capacity to fully comply with the physical activity and weight control requirements of the intervention.

^‡Although physical activity has been associated with reduced breast cancer risk in both pre- and postmenopausal women, the strongest evidence of a relationship between weight control and breast cancer incidence exists among postmenopausal women. For the survivorship trial, because breast cancer treatment often induces menopause, most women either will be postmenopausal or will become postmenopausal during their participation in the trial.

^§Oversampling may ensure sufficient representation among racial and ethnic groups.

^‖Further exploration of medical clearance requirements from other trials may help to inform the extent of and process for meeting clearance requirements.

^¶These lower limits for BMI ensure that all women in the trial will benefit from weight loss, thus precluding the need for two interventions (weight maintenance and weight loss). Obesity would not be a reason for exclusion as long as a woman was able to complete the physical activity component of the intervention. An upper BMI limit of 45 kg/m² is suggested because of unique physical activity intervention requirements.

^#Women who have had a heart attack or stroke within the past 6 months would be excluded.