BridgeMD
New treatment option for Breast Neoplasms
Official title A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer
ClinicalTrials.gov ID: NCT07287098
What this study is testing
What is Imlunestrant?
Imlunestrant is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for breast neoplasms.
Also referred to as LY3484356.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will include two groups of patients: Cohort 1 and Cohort 2. Cohort 1: will help researchers learn how a medicine called imlunestrant (LY3484356) affects a specific type of breast cancer.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Cohort 1:
- Have histologically confirmed Stage I to III Estrogen Receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) invasive...
- Be willing and able to provide pre- and on-treatment tumor samples.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Be able to swallow capsules or tablets.
You likely can't join if
- Cohort 1:
- Have bilateral invasive metastatic, occult primary, or inflammatory breast cancer.
- Have had prior bilateral oophorectomy or ovarian ablation.
- Have a serious medical condition
- Had major surgery within 28 days prior to randomization.
- Have a history of other cancer (except non melanoma skin cancer, Stage I uterine cancer, or carcinoma in situ of the cervix or other in situ cancer)...
See the full eligibility criteria
- Cohort 1:
- Have histologically confirmed Stage I to III Estrogen Receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) invasive breast carcinoma with Ki-67 at least 10%
- Be willing and able to provide pre- and on-treatment tumor samples.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Be able to swallow capsules or tablets.
- Be premenopausal women.
- If of childbearing potential must use 1 highly effective method of non-hormonal contraception while receiving study treatment and for the duration specified in protocol.
- Have adequate organ function. Cohort 2:
- Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis
- Have undergone definitive loco-regional therapy.
- Have received at least 4.5 years of any adjuvant endocrine therapy (ET), or at least 2 years of adjuvant ET with no additional ovarian suppression planned.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Be able to swallow capsules or tablets.
- Be premenopausal women
- If of childbearing potential must use 1 highly effective method of non-hormonal contraception while receiving study treatment and for the duration specified in protocol.
- Have adequate organ function.
- Cohort 1:
- Have bilateral invasive metastatic, occult primary, or inflammatory breast cancer.
- Have had prior bilateral oophorectomy or ovarian ablation.
- Have a serious medical condition
- Had major surgery within 28 days prior to randomization.
- Have a history of other cancer (except non melanoma skin cancer, Stage I uterine cancer, or carcinoma in situ of the cervix or other in situ cancer), unless in complete remission with no therapy for a minimum of 1 year.
- Plan to receive concurrent neoadjuvant therapy with any other non-protocol anticancer therapy.
- Have had any prior therapy for an invasive or non-invasive breast cancer.
- Have had prior radiotherapy to the ipsilateral chest wall for any malignancy.
- Have received prior anti-estrogen therapy, including for osteoporosis or prevention of breast cancer.
- Have had prior treatment with any Gonadotropin-releasing hormone (GnRH) agonist within 12 months prior to randomization.
- Receiving current exogenous reproductive hormone therapy Cohort 2:
- Have ovarian cyst(s) greater than (\>) 1 centimeter (cm) at screening.
- Have metastatic occult primary, or inflammatory breast cancer.
- Have had prior bilateral oophorectomy or ovarian ablation.
- Have a serious medical condition
- Had major surgery within 28 days prior to randomization.
- Have a history of other cancer (except non melanoma skin cancer or carcinoma in situ of the cervix or other in situ cancer), unless in complete remission with no therapy for a minimum of 1 year.
- Completed or discontinued prior adjuvant ET \>6 months prior to screening.
- Have received prior therapy with any selective estrogen receptor degrader (SERD).
- Receiving current exogenous reproductive hormone therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Chandler, Arizona, United States
- Los Angeles, California, United States
- Santa Monica, California, United States
- Greeley, Colorado, United States
- Loveland, Colorado, United States
- Altamonte Springs, Florida, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Albany, New York, United States
- New York, New York, United States
- Rochester, New York, United States
- Shirley, New York, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
+ 50 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Chandler, Arizona, United States; Los Angeles, California, United States; Santa Monica, California, United States; Greeley, Colorado, United States; Loveland, Colorado, United States and 64 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.