A Study of Changes in Ki67 Expression in People With Breast Cancer Receiving Endocrine Therapy Be… (NCT06127979) | Clinical Trial Compass
RecruitingNot Applicable
A Study of Changes in Ki67 Expression in People With Breast Cancer Receiving Endocrine Therapy Before Surgery
United States42 participantsStarted 2024-08-30
Plain-language summary
The researchers are doing this study to look at changes in Ki67 expression after at least 2 weeks of endocrine therapy in people with ER+/HER2- breast cancer undergoing cancer removal surgery. Participants will receive the endocrine therapy before their surgery. The researchers will look at how changes in Ki67 expression compare between participants who are carriers of the BRCA2 mutation and participants who are noncarriers of the BRCA2 mutation.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Postmenopausal women aged ≥18 years with biopsy-proven stage I-III invasive breast cancer that is ER+/HER2-
* Scheduled to undergo upfront surgery
* Eligible for genetic testing in accordance with National Comprehensive Cancer Network guidelines(BRCA2 arm only)
Exclusion Criteria:
* History of breast cancer
* Receipt of ET for risk reduction in the previous 3 months
* Stage IV disease at presentation
* Scheduled to undergo neoadjuvant systemic chemotherapy
* Pregnant
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is measuring changes in Ki67, a marker of how fast cancer cells are dividing — can you explain what my current Ki67 level is and what it would mean if it changes during the endocrine therapy before my surgery?
2Since this trial is listed as 'Phase NA,' it doesn't seem to be testing a new drug but rather observing how endocrine therapy affects my tumor before surgery — does that mean the treatment itself is already considered standard care, and what, if anything, would be different about my treatment if I joined versus not joining?
3The study involves endocrine therapy given before surgery — is that approach already being considered as part of my treatment plan, and if not, would enrolling in this study change the timing or type of surgery I'd have?
4Because this trial is focused on measuring Ki67 changes rather than testing a new drug, what are the main reasons you'd recommend I consider joining it, and are there any risks or burdens — like extra biopsies or visits — that I should weigh?
5If this study is primarily observational and my Ki67 results are being tracked, will I personally be able to learn what my results show, and could that information actually influence decisions about my own treatment going forward?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
assess the change in Ki67
Timeframe: baseline to at least 2 weeks of endocrine therapy