Actively Recruiting
A Phase 1b2 Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Combination Treatments for Metastatic Breast Cancer
Led by Stemline Therapeutics, Inc. · Updated on 2026-01-06
435
Participants Needed
118
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of elacestrant combined with other treatments in adults with advanced or metastatic estrogen receptor positive and HER2 negative breast cancer. This Phase 1b2 trial aims to find the best dose of elacestrant when given with drugs like alpelisib, everolimus, palbociclib, capivasertib, and ribociclib, then assess how well these combinations work and their safety. Participants receive elacestrant with one of several other cancer drugs in different groups. Doses vary by combination, with elacestrant given daily in 28-day cycles alongside drugs such as alpelisib, everolimus, ribociclib, palbociclib, capivasertib, or abemaciclib. Phase 1b focuses on dose finding with up to 125 participants, and Phase 2 evaluates treatment effects with around 310 participants across multiple arms. During the trial, participants are monitored for side effects and cancer progression. Measurements include dose-limiting toxicities in the first 28 days and progression-free survival at 6 months. Additional assessments cover drug levels, response rates, duration of response, clinical benefit, survival, and safety over several months. The study includes regular visits for evaluations and continues until the study ends or participants stop treatment.
CONDITIONS
Brief Title
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before study activities
- Adults aged 18 years or older, women of any menopausal status or men
- Histologically or cytologically confirmed estrogen receptor positive, HER2 negative breast cancer
- Documented disease progression during or after most recent therapy
- At least one measurable lesion per RECIST v1.1 criteria
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate bone marrow and organ function based on specific lab values
- Specific hormone therapy history required depending on treatment arm
- PIK3CA mutation required for alpelisib combination
- PIK3CA/AKT1/PTEN alteration required for capivasertib combination
- Recruitment for capivasertib arm only where locally approved and available
You will not qualify if you...
- Active or newly diagnosed central nervous system metastases or meningeal carcinomatosis, except stable brain or subdural metastases under specific conditions
- Advanced symptomatic visceral disease with risk of life-threatening complications
- Prior chemotherapy or elacestrant in advanced/metastatic setting
- Known germline BRCA mutation without prior PARP inhibitor treatment
- Prior therapy with investigational estrogen receptor degraders in metastatic setting
- Concurrent or recent invasive malignancy within 3 years, with exceptions
- Uncontrolled infections or active hepatitis or HIV with detectable viral load
- Prior pneumonitis or interstitial lung disease
- Major surgery within 28 days before treatment
- Inability to take oral medications or significant gastrointestinal conditions
- Known intolerance to elacestrant or excipients
- Pregnant or breastfeeding women and inadequate contraception use
- Use of certain medications or herbal supplements within specified timeframes
- Evidence of ongoing alcohol or drug abuse
- Severe medical or psychiatric conditions preventing participation
- Additional drug-specific exclusions for prior treatments and intolerances
- QT interval prolongation or risk factors for ribociclib and capivasertib combinations
- Diabetes restrictions for alpelisib and capivasertib arms
Research Team
S
Stemline Trials
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