Actively Recruiting
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
Led by Northwestern University · Updated on 2025-10-20
174
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype. Endocrine therapy is the mainstay of treatment; however, due to the varied nature of the disease, development of resistance to this therapeutic approach is very common in the metastatic setting. The purpose of this study is to see whether the effectiveness of elacestrant can be enhanced by combining it with a targeted agent such as a CDK4/6 inhibitor to treat patients with ER+/HER2- or metastatic breast cancer with prior exposure to a CDK4/6 inhibitor.
CONDITIONS
Official Title
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have confirmed estrogen receptor-positive and HER2-negative breast cancer
- Patients must have a confirmed ESR1 mutation
- Patients must have at least one measurable lesion or a mainly lytic metastatic bone lesion
- Patients must have received at least 2 prior endocrine therapies including a CDK4/6 inhibitor
- Patients must be 18 years or older
- Patients of childbearing potential under 55 must have confirmed menopause by FSH level > 40 mIU/mL
- Patients must have an ECOG performance status of 0 or 1
- Patients must have adequate organ and bone marrow function as defined in the criteria
- Patients with HIV must have undetectable viral load for 6 months on therapy
- Patients with chronic hepatitis B must have undetectable viral load on suppressive therapy
- Patients with hepatitis C must be treated and cured or have undetectable viral load if on treatment
- Patients with prior or concurrent malignancies without interfering safety or efficacy are eligible
- Patients with cardiac disease must be NYHA Class 2B or better
- Patients of childbearing potential and partners must agree to use contraception
- Patients must be willing and able to sign informed consent
- For combination therapy arm, patients must have had 1 or 2 prior hormonal therapies in metastatic setting with at least one combined with a CDK4/6 inhibitor
You will not qualify if you...
- Patients who have received prior elacestrant
- Patients who had chemotherapy or radiotherapy within 28 days (6 weeks for certain drugs)
- Patients who took steroid or immunosuppressive therapy within 7 days before treatment
- Patients with brain metastases unless stable and treated with low corticosteroid dose
- Patients not recovered from prior anti-cancer therapy side effects above Grade 3 except alopecia
- Patients receiving other investigational agents
- Patients with advanced symptomatic visceral spread at high short-term risk
- Patients with documented pneumonitis or interstitial lung disease
- Patients who had major surgery within 28 days before starting therapy
- Patients taking strong or moderate CYP3A4 inducers or inhibitors
- Patients with allergic reactions to similar compounds to elacestrant
- Patients with uncontrolled illnesses including uncontrolled hypertension or psychiatric illness
- Patients with refractory or chronic nausea, gastrointestinal conditions impacting drug absorption
- Patients unable to take or retain oral medications
AI-Screening
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Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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