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Cancer Vaccine
DPX-Survivac + Hormone/Radiation/Cyclophosphamide for Breast Cancer
Phase 1
Waitlist Available
Led By Sasha Stanton, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women with resectable, non-metastatic breast cancer that is >1 cm, hormone receptor positive, HER2 negative, Ki67>10%
Patients must be at least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study day 1, day 8, day 15, day 29, day 36, week 7-9, week 11, and 6 months post-surgery
Awards & highlights
Study Summary
This trial is testing whether it's safe to give stage I to III hormone receptor-positive, HER2-negative breast cancer patients neoadjuvant aromatase inhibitor therapy with DPX-Survivac, DPX-Survivac plus radiation, or DPX-Survivac with cyclophosphamide.
Who is the study for?
This trial is for post-menopausal women with resectable, non-metastatic breast cancer that's hormone receptor positive and HER2 negative. Participants should have a tumor larger than 1 cm, be at least 18 years old with good performance status, and have adequate organ function. They must not have had previous breast cancer treatments or certain other conditions.Check my eligibility
What is being tested?
The study tests the safety of neoadjuvant aromatase inhibitor therapy combined with DPX-Survivac alone, DPX-Survivac plus radiation (10Gy x2), or DPX-Survivac with cyclophosphamide (50mg). Each participant will also take letrozole (2.5mg daily) during the six-week pre-surgery treatment phase.See study design
What are the potential side effects?
Potential side effects may include reactions to vaccine components like DPX-Survivac, hormonal changes from letrozole, blood count changes from cyclophosphamide, and skin irritation from radiation. The exact side effects will vary depending on the treatment arm.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is operable, not spread, larger than 1 cm, hormone-sensitive, HER2 negative, and has a high growth rate.
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I am 18 years old or older.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout the study day 1, day 8, day 15, day 29, day 36, week 7-9, week 11, and 6 months post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study day 1, day 8, day 15, day 29, day 36, week 7-9, week 11, and 6 months post-surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Secondary outcome measures
Immunogenicity of each therapeutic arm GEO-Mx digital spatial profiler
Immunogenicity of each therapeutic arm IFN-γ ELISPOT
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C: DPX-Survivac, Letrozole, cyclophosphamideExperimental Treatment3 Interventions
Letrozole 2.5 mg po daily, cyclophosphamide 50 mg po BID, DPX-Survivac 0.25 mL SC week 2 and Week 5
Group II: Arm B: DPX-Survivac, Letrozole, RadiationExperimental Treatment3 Interventions
Letrozole 2.5 mg po daily, XRT 10 Gy x 2, DPX-Survivac 0.25 mL SC week 2 and Week 5
Group III: Arm A: DPX-Survivac, LetrozoleExperimental Treatment2 Interventions
Letrozole 2.5 mg po daily, DPX-Survivac 0.25 mL SC week 2 and Week 5
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DPX-Survivac
2013
Completed Phase 2
~90
Letrozole
FDA approved
Cyclophosphamide
FDA approved
Find a Location
Who is running the clinical trial?
Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,529 Total Patients Enrolled
6 Trials studying Breast Cancer
4,602 Patients Enrolled for Breast Cancer
Sasha Stanton, MDPrincipal InvestigatorProvidence Health & Services
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can have an MRI as per my doctor's assessment.I understand the study details and am willing to sign the consent form.I cannot take aromatase inhibitors for my condition.I have had breast cancer or used tamoxifen or aromatase inhibitors before.You have used experimental immune therapy in the past.I have had radiation therapy on my breast before.Your recent blood tests should show that you have enough white blood cells, hemoglobin, neutrophils, lymphocytes, and platelets. Your kidney and liver function should also be within normal limits.I have not and do not plan to receive chemotherapy before surgery.I have not had cancer in the past 5 years, except for skin cancer or serious cervical issues.I am not pregnant and I am post-menopausal.I have a history of HIV, hepatitis B, or hepatitis C.My breast cancer is operable, not spread, larger than 1 cm, hormone-sensitive, HER2 negative, and has a high growth rate.My autoimmune disease has been under control for the last year.I am currently not suffering from major infections or serious illnesses that would prevent me from receiving treatment.I am 18 years old or older.I haven't taken any systemic steroids in the last 28 days.I am fully active or can carry out light work.I am post-menopausal according to the NCCN definition.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: DPX-Survivac, Letrozole
- Group 2: Arm B: DPX-Survivac, Letrozole, Radiation
- Group 3: Arm C: DPX-Survivac, Letrozole, cyclophosphamide
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there risks associated with the DPX-Survivac treatment?
"Since this is only a Phase 1 trial, there is limited data to support the safety and efficacy of DPX-Survivac."
Answered by AI
What cancerous cells does DPX-Survivac target?
"DPX-Survivac has potential as a treatment for patients with multiple sclerosis as well as other diseases like leukemia, myelocytic, acute, tamoxifen, and retinoblastoma."
Answered by AI
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