Breast Cancer Metastatic Breast Cancer, HER2-negative Breast Cancer
Conditions
Keywords
HER-2 Negative Breast Cancer, Metastatic Breast Cancer
Brief summary
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.
Interventions
DRUGElacestrant
345 mg (or 86 mg tablets) orally daily during vaccination and continued after until progression. Cycle Length 28 days (4 weeks)
BIOLOGICALDC1 native/mutated ESR1
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.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
The V Foundation for Cancer Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. 1. Estrogen Receptor (ER) or Progesterone Receptor (PR) are considered positive when expressed ≥1% on immunohistochemistry (IHC). 2. 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: 1. absolute neutrophil count ≥1,000/mcL 2. 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 Gilbert's syndrome unconjugated hyperbilirubinemia) * 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Successful Completion | Up to 2 years | 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. |
| Occurrence Rate | Up to 2 years | 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. |
| Occurrence of Treatment Related Adverse Events | Up to 2 years | Number of participants with treatment related adverse events, per event category. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Up to 2 years | Progression Free Survival (PFS) is measured from the start of treatment until disease progression or death from any cause. |
| Clinical Benefit Rate (CBR) | Up to 2 years | Clinical Benefit Rate (CBR) is measured by Complete Response (CR) + Partial Response (PR) + Stable Disease. |
| Overall Response Rate (ORR) | Up to 2 years | Overall Response Rate (ORR) is measured by Complete Response (CR) + Partial Response (PR). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAixa Soyano Muller, MD
Moffitt Cancer Center
Outcome results
None listed