Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT06557057
Eligibility Criteria:
Inclusion Criteria:
* Post-menopausal women with hormone receptor positive breast cancer or ductal carcinoma in situ (DCIS). Post-menopause will be defined as women who experience 12 months of amenorrhea or have undergone bilateral salpingo-oophorectomy.
* 25 women who are planning to start or are within 6 months of starting treatment with aromatase inhibitors, after consultation in breast clinic and cancer center.
* 25 women who will be starting Tamoxifen (comparative group)
* 25 healthy post menopausal women will also be recruited.
Exclusion Criteria:
* Established diagnosis of diabetes
* Therapy with medications that could affect glucose metabolism
* Screening fasting glucose ≥ 126 mg/dl, and/or HbA1c ≥ 6.5%
* History of upper GI surgery that alters gastric emptying or causing malabsorption e.g., bariatric surgery, fundoplication
Healthy Volunteers:
True
Sex:
FEMALE
Study:
NCT06557057
Study Brief:
Protocol Section:
NCT06557057