Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06691035
Phase
PHASE1
Status
Recruiting
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Conditions

  • Breast Cancer Metastatic Breast Cancer
  • HER2-negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elacestrant — DRUG
    345 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
    2.0-5.0 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.

Study Details

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.

Key Dates

Start date
Nov 4, 2024
Status verified
Dec 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Elacestrant + DC1
    Patients will undergo apheresis of peripheral blood to collect and create DC1 vaccines. DC1 will be pulsed with ESR1 native or mutated peptides. After DC1 vaccines have undergone safety testing and are ready to be used, patients will be injected in groin nodes (or accessible breast tumor if available) weekly with these pulsed DC1 for eight consecutive weeks. They will alternate between native ESR1 DC1s and mutated ESR1 DC1s. Patients will receive combination of DC1 vaccinations and Elacestrant concurrently. Elacestrant is a novel oral selective estrogen downregulator, administered during vaccination and continued after. Elacestrant is considered standard of care for patients with ESR1 mutated HR+ HER2-metastatic breast cancer. Pulsed DC1 will be administered after initial induction every four weeks x 3 doses.

Primary Outcome Measure

Rate of Successful Completion [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Aixa Soyano Muller, MD (PRINCIPAL_INVESTIGATOR)
Mohammed Al-Jumayli, MD (SUB_INVESTIGATOR)
Avan Armaghani, MD (SUB_INVESTIGATOR)
Ricardo Costa, MD (SUB_INVESTIGATOR)
Brian Czerniecki, MD, PhD (SUB_INVESTIGATOR)
Martine Extermann, MD (SUB_INVESTIGATOR)
Heather S Han, MD (SUB_INVESTIGATOR)
Susan J Hoover, MD (SUB_INVESTIGATOR)
Nazanin Khakpour, MD, F.A.C.S. (SUB_INVESTIGATOR)
John Kiluk, MD (SUB_INVESTIGATOR)
Laura Kruper, MD (SUB_INVESTIGATOR)
Christine Laronga, MD (SUB_INVESTIGATOR)
Marie C Lee, MD (SUB_INVESTIGATOR)
Loretta S Loftus, MD (SUB_INVESTIGATOR)
Melisssa Mallory, MD (SUB_INVESTIGATOR)
Tracey O'Connor, MD (SUB_INVESTIGATOR)
Christine Sam, MD (SUB_INVESTIGATOR)

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By research site
Moffitt Cancer Center· Tampa, FL

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