Neoadjuvant DPX-Survivac Aromatase Inhibition, Radiotherapy or Cyclophosphamide in HR+HER2- Breas… (NCT04895761) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Neoadjuvant DPX-Survivac Aromatase Inhibition, Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer
United States6 participantsStarted 2021-09-10
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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:
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
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.
Timeframe: The safety assessment period begins with day 1 and ends within 30 days of surgical excision.