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New treatment option for Breast Cancer Metastatic Breast Cancer
Official title Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06691035
What this study is testing
What is Elacestrant?
Elacestrant is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for breast cancer metastatic breast cancer.
Also referred to as Oserdu.
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 is a pilot study to determine feasibility and safety of the combination of Dendritic Cell (DC1) vaccines and elacestrant in patients with hormone positive HER2 negative metastatic breast cancer.
- Phase 1: an early, usually small safety study
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
You may be able to join if
- Participants must have histologically or cytologically confirmed diagnosis of hormone positive HER2 negative metastatic breast cancer per ASCO/CAP...
- Estrogen Receptor (ER) or Progesterone Receptor (PR) are considered positive when expressed ≥1% on immunohistochemistry (IHC).
- HER2 is considered negative by IHC when expression is 0 or 1+ and if equivocal 2+ then a reflex in situ hybridization should be not amplified...
- Participants must have Presence of an ESR1 mutation detected via tissue based or blood based (ctDNA) genomic profiling.
- Participants must have been previously treated with at least 1 line of endocrine therapy and a CDK 4/6 inhibitor in the metastatic setting.
You likely can't join if
- are eligible for this trial.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Participants must have the ability to understand and the willingness to sign a written informed consent document or have a legally authorized...
- Participants with treated and stable brain metastases are eligible if brain imaging shows no evidence of progression within 2 months of trial...
- Pregnant women are excluded from this study because study treatment agent(s) used in this study may have the potential for teratogenic or...
- Previous treatment with Elacestrant.
See the full eligibility criteria
Who can join
- Participants must have histologically or cytologically confirmed diagnosis of hormone positive HER2 negative metastatic breast cancer per ASCO/CAP criteria, with diagnosis established through either a breast/axillary...
- Estrogen Receptor (ER) or Progesterone Receptor (PR) are considered positive when expressed ≥1% on immunohistochemistry (IHC).
- HER2 is considered negative by IHC when expression is 0 or 1+ and if equivocal 2+ then a reflex in situ hybridization should be not amplified (standard practice per ASCO/CAP criteria).
- Participants must have Presence of an ESR1 mutation detected via tissue based or blood based (ctDNA) genomic profiling.
- Participants must have been previously treated with at least 1 line of endocrine therapy and a CDK 4/6 inhibitor in the metastatic setting.
- Participants must have measurable or nonmeasurable (evaluable) disease on imaging by RECIST v1.1.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Participants must be adults 18 years or older.
- Participants must have the ability to understand and the willingness to sign a written informed consent document.
- Participants must be able to read and speak standard English or Spanish.
- Participants must have adequate organ and marrow function as defined below:
- absolute neutrophil count ≥1,000/mcL
- platelets ≥75,000/mcL d. AST(SGOT)/ALT(SGPT) ≤3 fold × institutional ULN e. creatinine 1.5 ≤ institutional ULN f. hemoglobin (Hb) ≥ 9 g/dL g. Total bilirubin \< 1.5 x ULN or \<3 x ULN in the presence of documented...
- Participants must have a negative pregnancy test for pre-menopausal women of childbearing potential.
- Participants that are pre-menopausal women of childbearing potential who are sexually active with a male partner must agree to use adequate contraception prior to the study, for the duration of study participation.
- Inclusion of minorities: patients of all races and ethnic groups who meet the above inclusion and below
What rules you out
- are eligible for this trial.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Participants must have the ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the participant's behalf.
- Participants with treated and stable brain metastases are eligible if brain imaging shows no evidence of progression within 2 months of trial enrollment. Exclusion Criteria:
- Pregnant women are excluded from this study because study treatment agent(s) used in this study may have the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for...
- Previous treatment with Elacestrant.
- History of allergic reactions attributed to the study drugs.
- Active, progressing or newly diagnosed CNS metastases, including leptomeningeal carcinomatosis, because systemic treatment would need to be paused for these patients.
- Treatment with any investigational compound within 21 days prior to the first dose of study drugs or during this study.
- 14 day washout periods from previous anticancer therapy(ies) is required prior to enrollment including:
- Cytotoxic chemotherapy
- Tamoxifen or aromatase inhibitors
- Fulvestrant
- Targeted agents such as CDK 4/6 inhibitors, PIK3CA inhibitors, MTOR inhibitors
- Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with...
- Uncontrolled intercurrent illness including-but not limited to-ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Patients with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary...
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
- Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HbsAg]), or hepatitis C (HCV). Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core...
- Concurrent or prior use of immunosuppressive medication within 14 days before the first dose of study drugs, with the following exceptions: premedication with dexamethasone, intranasal, inhaled, topical or local steroid...
- Inability to comply with protocol requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. 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.