What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving aromatase inhibitors and immunotherapy, can have several side effects. Aromatase inhibitors like letrozole may cause loss of bone density, fractures, and cardiovascular risks. Immunotherapy, which aims to stimulate the immune system to target cancer cells, can lead to fatigue, skin reactions, and flu-like symptoms. When combined with other treatments such as cyclophosphamide or radiation, additional side effects like nausea, vomiting, and increased risk of infections may occur.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer that are similar to DPX-Survivac, which targets the survivin protein to stimulate an immune response, include several immunotherapies and targeted therapies. Ado-trastuzumab emtansine (T-DM1) and fam-trastuzumab deruxtecan (T-DXd) are notable examples. These drugs combine HER2-targeted therapy with cytotoxic agents to enhance the immune system's ability to fight cancer. Additionally, pembrolizumab, an immune checkpoint inhibitor, has been approved for certain types of breast cancer, particularly those expressing PD-L1. These treatments represent significant advancements in leveraging the immune system to combat breast cancer.

What other types of research exist?

Promising novel alternatives to DPX-Survivac for breast cancer patients include: 1) Immune checkpoint inhibitors such as pembrolizumab (Keytruda) and atezolizumab (Tecentriq), which have shown efficacy in certain subtypes of breast cancer. 2) PARP inhibitors like olaparib (Lynparza) and talazoparib (Talzenna) for patients with BRCA mutations. 3) Antibody-drug conjugates such as trastuzumab deruxtecan (Enhertu) for HER2-positive breast cancer. 4) CDK4/6 inhibitors like palbociclib (Ibrance) and ribociclib (Kisqali) in combination with hormone therapy for HR-positive, HER2-negative breast cancer.

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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

Must not have

Patients unable to receive an aromatase inhibitor

Previous breast cancer, tamoxifen, or aromatase inhibitor use

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

Summary

This trial tests a cancer vaccine combined with radiation or low-dose chemotherapy, plus hormone therapy, in women with certain types of breast cancer. The goal is to boost the immune system, reduce tumor recurrence, and slow tumor growth.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take aromatase inhibitors for my condition.

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I have had breast cancer or used tamoxifen or aromatase inhibitors before.

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I have had radiation therapy on my breast before.

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I am not pregnant and I am post-menopausal.

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I have a history of HIV, hepatitis B, or hepatitis C.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study day 1, day 8, day 15, day 29, day 36, week 7-9, week 11, and 6 months post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments often include immunotherapy, hormone therapy, and chemotherapy. Immunotherapy, such as DPX-Survivac, targets proteins like survivin to stimulate the immune system to attack cancer cells, offering a personalized approach to treatment. Hormone therapies, like aromatase inhibitors, reduce estrogen levels to slow the growth of hormone receptor-positive breast cancers. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells. These treatments are crucial as they provide multiple strategies to target cancer cells, improving patient outcomes and offering options tailored to individual tumor characteristics.