Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 biopsy or biopsy of a metastatic lesion.
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.
Disqualifiers
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.
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 adverse events in nursing infants secondary to treatment of the mother with agents used in this study, breastfeeding should be discontinued if the mother is treated with study agents used in this study.
Trial design
Design model
Single group
Treatments tested in this trial
Elacestrant
Drug345 mg (or 86 mg tablets) orally daily during vaccination and continued after until progression. Cycle Length 28 days (4 weeks)
DC1 native/mutated ESR1
Biological/Vaccine2.0-5.0 x 10 (20-50 million) cells (Injections in groin nodes (or accessible breast tumor if available) weekly with DC1 for eight consecutive weeks, alternating between native ESR1 DC1s and mutated ESR1 DC1s. Mutated ESR1 DC1s on week 1 followed by native ESR1 DC1s on week 2, alternating during the initial vaccination series and the subsequent booster phase. Pulsed DC1 will be administered after initial induction every four weeks x 3 doses.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Elacestrant + DC1Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Rate of Successful Completion
Feasibility: Defined as a patient's ability and willingness to complete the treatment regimen (8 weeks) to End of Treatment (EOT) (window of + 30 days from date of last study treatment). Data collection will include rate of successful completion.
Time frame
Up to 2 years2
Occurrence Rate
Feasibility: Defined as a patient's ability and willingness to complete the treatment regimen (8 weeks) to End of Treatment (EOT) (window of + 30 days from date of last study treatment). Data collection will include occurrence rate for each reason stated for non-completion.
Time frame
Up to 2 years3
Occurrence of Treatment Related Adverse Events
Number of participants with treatment related adverse events, per event category.
Time frame
Up to 2 yearsSecondary outcomes
1
Progression Free Survival (PFS)
Progression Free Survival (PFS) is measured from the start of treatment until disease progression or death from any cause.
Time frame
Up to 2 years2
Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR) is measured by Complete Response (CR) + Partial Response (PR) + Stable Disease.
Time frame
Up to 2 years3
Overall Response Rate (ORR)
Overall Response Rate (ORR) is measured by Complete Response (CR) + Partial Response (PR).
Time frame
Up to 2 yearsOther outcomes
1
Dose Limiting Toxicity
Dose limiting toxicity (DLT) is defined as grade ≥ 3 non-hematologic toxicity; grade ≥ 3 hematologic toxicity thought be at least possibly related to vaccines. Toxicity data will be reviewed after small groups of patients have been treated and observed for 30 days after the last vaccination. The study will enroll a total number of 18 patients. Enrollment will be suspended if data suggest that the rate of unacceptable vaccine-related toxicity exceeds 25%.
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
The V Foundation for Cancer Research
Collaborator
Source ClinicalTrials.gov