Neoadjuvant DPX-Survivac Aromatase Inhibition, Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer

NCT04895761 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: P2100-SUR-S11
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The study seeks to establish the safety of neoadjuvant aromatase inhibitor with: DPX-Survivac, DPX-Survivac plus radiation, or DPX-Survivac with cyclophosphamide in stage I to III HR+HER2- breast cancer. There will be sequential enrollment into 3 arms with an anticipated N=6 participants per arm for N=18 participants in total. All participants will receive letrozole 2.5 mg daily during the 6 weeks of neoadjuvant therapy. Neoadjuvant therapy occurs weeks 1-6, with standard of care surgery taking place week 7 to 9.

Conditions

Breast Cancer

Keywords

HR+/HER2

Outcome Measures

Primary Outcomes (1)

• Number of participants without the following safety events: TASAEs, persistent grade III/IV TAAEs, or toxicity-related delays in curative-intent surgery. Toxicity graded by CTCAE v5.0 and monitoring of AEs performed per FDA and NCI guidelines.

  yes/no outcome variable, ascertained for each individual subject, and reported as a binomial proportion for each arm. Safety will be reported for all subjects who receive at least one dose of drug/radiation/study therapy

  The safety assessment period begins with day 1 and ends within 30 days of surgical excision.

Secondary Outcomes (2)

• Immunogenicity of each therapeutic arm IFN-γ ELISPOT

  throughout the study day 1, Day 8, Day 15, Day 29, Day 36, Week 7-9, Week 11, and 6 months post-surgery

• Immunogenicity of each therapeutic arm GEO-Mx digital spatial profiler

  throughout the study day 1, Day 8, Day 15, Day 29, Day 36, Week 7-9, Week 11, and 6 months post-surgery

Study Arms (3)

Arm A: DPX-Survivac, Letrozole

EXPERIMENTAL

Letrozole 2.5 mg po daily, DPX-Survivac 0.25 mL SC week 2 and Week 5

Biological: DPX-Survivac; Drug: Letrozole 2.5mg

Arm B: DPX-Survivac, Letrozole, Radiation

EXPERIMENTAL

Letrozole 2.5 mg po daily, XRT 10 Gy x 2, DPX-Survivac 0.25 mL SC week 2 and Week 5

Biological: DPX-Survivac; Drug: Letrozole 2.5mg; Radiation: XRT 10Gy x2

Arm C: DPX-Survivac, Letrozole, cyclophosphamide

EXPERIMENTAL

Letrozole 2.5 mg po daily, cyclophosphamide 50 mg po BID, DPX-Survivac 0.25 mL SC week 2 and Week 5

Biological: DPX-Survivac; Drug: Letrozole 2.5mg; Drug: Cyclophosphamide 50mg

Interventions

DPX-Survivac BIOLOGICAL

DPX is a novel formulation that when combined with target antigens acts to activate T cells. It is a lipid-based formulation that creates a long lasting depot at the site of injection, forcing an "active uptake" by antigen presenting cells (APCs). APCs traffic to regional lymph nodes where naïve T cells are activated, inducing strong and sustained immune responses. All arms will receive DPX-Survivac on weeks 2 and 5.

Arm A: DPX-Survivac, Letrozole; Arm B: DPX-Survivac, Letrozole, Radiation; Arm C: DPX-Survivac, Letrozole, cyclophosphamide

Letrozole 2.5mg DRUG

Aromatase inhibitor all arms will receive

Also known as: Femara

Arm A: DPX-Survivac, Letrozole; Arm B: DPX-Survivac, Letrozole, Radiation; Arm C: DPX-Survivac, Letrozole, cyclophosphamide

Cyclophosphamide 50mg DRUG

oral chemotherapy used in the neoadjuvant setting for Arm C only

Also known as: cytoxan

Arm C: DPX-Survivac, Letrozole, cyclophosphamide

XRT 10Gy x2 RADIATION

Directed radiation at week 4 for Arm B only

Arm B: DPX-Survivac, Letrozole, Radiation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women with resectable, non-metastatic breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must provide informed consent prior to any study-specific procedures and be able to understand and be willing to sign an informed consent document. Results of standard-of-care tests or examinations performed prior to obtaining informed consent and prior to treatment may be used for screening assessments rather than repeating such evaluations if within 30 day of day 1.
• Women with resectable, non-metastatic breast cancer that is \>1 cm, hormone receptor positive, HER2 negative, Ki67\>10%.
• HER2 negative is defined as:
• + HER2 expression by immunohistochemistry (IHC) OR Fluorescence in situ hybridization (FISH) negative OR HER2 2+ and FISH negative
• Patients must be at least 28 days post systemic steroids prior to enrollment.
• Patients must be at least 18 years of age.
• Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status Score of ≤ 1
• Adequate laboratory values within 30 days of enrollment defined as follows:
• White blood cell (WBC) ≥ 3000/mm3
• Hemoglobin (Hgb) ≥ 9 g/dL
• Neutrophil count ≥ 1500/mm3
• Lymphocyte count ≥ 1000/mm3
• Platelet count ≥ 75,000/mm3
• Serum creatinine ≤ 2.0 mg/dL or creatinine clearance \> 60 ml/min
• Total bilirubin ≤ 1.5 mg/dL

You may not qualify if:

• Patients may not be receiving any other investigational agents or on concurrent clinical trials while on during the clinical trial period.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to DPX-Survivac.
• Pregnant and pre-menopausal women are excluded from this study because to keep anti-endocrine therapy consistent between patients.
• Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C.
• Uncontrolled autoimmune disease. Autoimmune disease allowed if controlled (with or without treatment) for the last 12 months.
• Patients may not have received or plan to receive neoadjuvant systemic chemotherapy. 7) Patients unable to receive an aromatase inhibitor
• \) Prior radiation to the affected breast 9) Previous cancers except for non-melanoma skin cancers or high risk cervical lesions in the past 5 years.
• \) Previous breast cancer, tamoxifen, or aromatase inhibitor use. 11) Previous investigational immune therapy use-

Sponsors & Collaborators

• Providence Health & Services: lead

Study Sites (1)

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds

Study Officials

• Sasha Stanton, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: September 10, 2021
• Primary Completion: June 16, 2023
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)