Spots Global Cancer Trial Database for Babytam vs Babyexe in Post-menopausal Women at High Risk for Breast Cancer.

Study Description

Brief Summary: The purpose of the study is to determine if 6 and 12 months of treatment with Tamoxifen at lower dose is superior to Exemestane at lower dose on quality of life.

Detailed Description: It is a multicenter, randomized, double blind, superiority phase IIb trial. Eligible patients will be randomized with a 1:1 ratio into: ARM 1: BabyTAM Arm, 10 mg eod, typically every odd day of the monthly calendar for 12 months or unless progression, SAE, medical decision, patient withdrawal occur. ARM 2: BabyEXE Arm, 25 mg eod, typically every odd day of the monthly calendar for 12 months or unless progression, SAE, medical decision, patient withdrawal occur. Blinding will be guaranteed by over-encapsulation of active tablet agents with an AA capsule in a 6-month bottle. In both arms, treatment should begin within 30 days from randomization. Tamoxifen and Exemestane will be provided for free by the Study Sponsor. After study completion, participants will be unblinded and treated according to local study guidelines. Clinical visit will be performed every 6 months (±14 days) with physical examination vital signs and weight and girth measurement, ECOG PS, MENQOL questionnaire (0, 6, 12 months), review of self-reported compliance, concomitant medications, AEs assessment, and physical exam. Telephone/video contact may be allowed at 3 and 9 months, whereas baseline, 6 months and 12 months visits are necessary for blood and stool collection and biomarker assessment. Blood serum and stool samples for centralized storage at IEO, Milan, Italy, will be collected at different time points.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial