A Study of LY3484356 in Women With Breast Cancer Before Having Surgery (NCT04647487) | Clinical Trial Compass
CompletedPhase 1
A Study of LY3484356 in Women With Breast Cancer Before Having Surgery
United States, Belgium, France87 participantsStarted 2021-04-21
Plain-language summary
The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage I-III) breast cancer, when given prior to surgery. Participation in this study could last up to 2.5 months.
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:
* Have histologically confirmed invasive ER+, HER2- breast carcinoma
* Be willing and able to provide pre- and on-treatment tumor samples
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale
* Have adequate organ function
* Be able to swallow capsules
* Be a postmenopausal woman
Exclusion Criteria:
* Have bilateral invasive breast cancer
* Have metastatic breast cancer
* Plan to receive concurrent neoadjuvant therapy with any other non-protocol anti-cancer therapy
* Have had prior therapy (of any kind) for an invasive or non-invasive breast cancer
* Have had prior radiotherapy to the ipsilateral chest wall for any malignancy
* Have had prior anti-estrogen therapy with raloxifene, tamoxifen, aromatase inhibitor, or other selective estrogen receptor modulator (SERM), either for osteoporosis or prevention of breast cancer
* Have had prior hormone-replacement therapy within 4 weeks of the start of study treatment
* Have had major surgery within 28 days prior to randomization to allow for post-operative healing of the surgical wound and site(s)
* Have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled
* Have another serious medical condition
* Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Percent Change From Baseline in Estrogen Receptor (ER) Expression