Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Menopause

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Exemestane

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Aromatase Inhibitors

Enzyme Inhibitors

BabyTAM Arm, 10 mg eod, typically every odd day of the monthly calendar for 12 months

BabyEXE Arm, 25 mg eod, typically every odd day of the monthly calendar for 12 months.

Tamoxifen 10 MG

Exemestane 25 MG

Andrea U De Censi, MD

Davide S Corradengo, SC

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.

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.

Babytam vs Babyexe in Post-menopausal Women at High Risk for Breast Cancer.

Randomized Double Blind Phase 2 Trial of Baby Tamoxifen Versus Baby Exemestane in Post-menopausal Women at High Risk for Breast Cancer. BabyTEARS (Baby Tamoxifen or Exemestane Assessment Randomized Study)

The primary endpoint is the change after 12 months of treatment between arms in the physical domain, including musculoskeletal/joint pain, of the Menopause-Specific Quality of Life Questionnaire (MENQOL), a validated tool to measure symptoms related to menopause or estrogen depletion potentially worsened by babyexe or babytam. Questionnaire scale setup: no, if yes the scale is from 0 (Not at all bothered) to 6 (extremely bothered).

Assessment of other domains of MENQOL such as vasomotor symptoms, sexual and psychological disturbances. Questionnaire scale setup: no, if yes the scale is from 0 (Not at all bothered) to 6 (extremely bothered).

Pill adherence through PMAS - which is the Promise Medication Adherence Scale. Questionnaire setup: scale from 1 (Strongly disagree - Never - Not at all) to 5 (Strongly agree - Always - very much)

Factors related to study participation or refusal before study entry, including breast cancer-related worry and presence of life style risk factors, and participant satisfaction of study explanation. Questionnaire setup: questions about accepting/refusing the trial, and satisfaction scale from 1 (Strongly agree) to 5 (strongly disagree).

The BPI Brief Pain Inventory short form questionnaire. Querstionnaire setup: pain is evaluated from 0 (best result) to 10 (worst result).

Spots Global Cancer Trial Database for tamoxifen 10 mg