A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer
A Phase II Study of STEMVAC Vaccine Therapy for Patients With Hormone Receptor Positive Metastatic Breast Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 3 years
- Procedures mentioned: Blood draws, CT scans, Biopsies, PET scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients also undergo image-guided biopsies for research purposes, as well as collection of blood samples and computed tomography (CT) or positron emission tomography (PET) scans throughout the trial."
- "Patients also undergo image-guided biopsies for research purposes, collection of blood samples, and fluoroestradiol (FES) positron emission tomography (PET) scans, as well as CT or PET scans throughout the trial."
- "After completion of study treatment, patients are followed every 6 months for 3 years."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the STEMVAC vaccine with standard hormone treatment plus a CDK4/6 drug, which blocks cancer growth, or with chemotherapy called capecitabine. It is for adults with breast cancer that uses hormones to grow, is HER2-negative or HER2-low, and has spread to other parts of the body. The vaccine is designed to help the immune system find and kill cancer cells.
This phase II trial studies how well a vaccine, STEMVAC, works in combination with standard endocrine-based therapy (ET) with a CDK4/6 targeted drug therapy, or with the chemotherapy drug capecitabine, in treating patients with hormone receptor (HR)-positive, HER2-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). STEMVAC is designed to target proteins that cancer cells use when they become more aggressive and start to spread, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. Standard ET is treatment that adds, blocks, or removes hormones in order to slow or stop the growth of cancer. Standard CDK4/6 inhibitors, including abemaciclib, may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Giving STEMVAC in combination with standard ET or chemotherapy may be an effective treatment for metastatic HR positive, HER2 negative breast cancer.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must be at least 18 and have breast cancer confirmed by a tissue test. The cancer must use estrogen or progesterone to grow, be HER2-negative or HER2-low, and have spread.
- You must be on your first or second hormone treatment for cancer that has spread, with at least 2 cycles of a CDK4/6 drug. If you stopped hormone treatment due to side effects but still take abemaciclib, the study leader may allow you to join.
- Or, your cancer must have worsened on hormone-based treatment, and you must have finished at least 1 cycle of capecitabine.
- You must be fully active or able to do light work despite some limits on hard physical activity.
- You must have a cancer site that can be sampled and agree to up to 2 biopsies, which remove small tissue samples.
- Blood tests within 28 days before the vaccine must meet the study's rules for blood cell counts and liver and kidney function.
- If you can become pregnant, you must have a negative pregnancy test and use 2 birth control methods. Men having sex with someone who can become pregnant must use a barrier method, such as a condom. These rules apply through the end of study treatment.
- You must have recovered from major infections or surgery and have no serious active health problem that would prevent study treatment.
Who can't join
- You have certain serious heart problems, including heart muscle disease, severe heart failure, fluid around the heart causing symptoms, recent unstable chest pain, or uncontrolled blood pressure or heart rhythm.
- You have a disease that needs long-term steroids or drugs that weaken the immune system, or currently use these drugs. Whole-body steroids within 30 days before study treatment also rule you out; some local treatments, such as creams or inhalers, are allowed.
- You have a cancer other than breast cancer that needed radiation or drug treatment within the past 5 years.
- You have a known allergy to GM-CSF, a substance given with the vaccine, or another reason you cannot receive it.
- You are pregnant or breastfeeding, or have a known history of HIV, hepatitis B, or hepatitis C infection.
- You had major surgery within 4 weeks before starting the study vaccine, or your cancer doctor finds another condition that could prevent you from taking part.
- You are in another study that gives experimental treatment, drugs, or treatment devices. Studies that only collect tissue or information are allowed.
- You receive another vaccine less than 14 days before or after a STEMVAC dose. This rule does not apply to the tetanus and diphtheria (Td) vaccine.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Patients must be at least ≥ 18 years of age * Histologically confirmed hormone receptor positive metastatic breast cancer: Tumors that are positive for estrogen receptor (ER) and/or progesterone receptor (PR) * HER2-negative or HER2-low will be included and defined as: * 0-1+ HER2 expression by immunohistochemistry (IHC) OR * Fluorescence in situ hybridization (FISH) negative OR * HER2 2+ and FISH negative * HER2 low per standard of care in breast cancer * Patients should be receiving the following therapies to be eligible for the study: * Cohort 1: First or second line of endocrine therapy in the metastatic setting, in combination with a CDK4/6 inhibitor. Patients must have completed at least 2 cycles of CDK4/6 inhibitor. Patients who have stopped endocrine therapy for intolerance but remain on abemaciclib monotherapy will be considered for enrollment at the PI's discretion * Cohort 2: Progressed on endocrine-based therapies and after completion of at least 1 cycle of capecitabine * Subjects with Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1 * Willing to undergo up to two serial biopsies while on study * Have at least 1 site of disease confirmed by the treating oncologist that could be biopsied during treatment * White blood cell (WBC) ≥ 2000/mm\^3 (within 28 days of receiving the study vaccine) * Lymphocyte count ≥ 500/mm\^3 (within 28 days of receiving the study vaccine) * Absolute neutrophil count (ANC) ≥ 800/µL (within 28 days of receiving the study vaccine) * Platelets ≥ 75,000/µL (within 28 days of receiving the study vaccine) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be ≤ 3.0 mg/dL (within 28 days of receiving the study vaccine) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x institutional upper limit of normal (ULN) (within 28 days of receiving the study vaccine) * Creatinine ≤ 2.0 mg/dL or creatinine clearance \> 30 mL/min (within 28 days of receiving the study vaccine) * Patients of child-bearing potential must agree to use dual methods of contraception and have a negative urine pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or postmenopausal. Effective methods of contraception must be used throughout the study and until the end of treatment on study * Must have recovered from major infections and/or surgical procedures; and in the opinion of the investigator, not have any significant active concurrent medical illnesses or condition precluding protocol treatment Exclusion Criteria: * Patients with any of the following cardiac conditions: * Symptomatic restrictive cardiomyopathy * Dilated cardiomyopathy * Unstable angina within 4 months prior to enrollment * New York Heart Association functional class III-IV heart failure on active treatment * Symptomatic pericardial effusion * Uncontrolled hypertension * Uncontrolled cardiac arrhythmias * Patients with any autoimmune disease/comorbidity that require chronic steroids or immunosuppressants * A non-breast malignancy requiring radiation or systemic therapy within last 5 years * Known hypersensitivity reaction to the granulocyte-macrophage colony-stimulating factor (GM-CSF) adjuvant; any known contra-indication to GM-CSF * Pregnant or breast feeding * Known history of human immunodeficiency virus (HIV) infection, hepatitis B (e.g., hepatitis B virus surface antigen \[HBsAg\] reactive), or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected) * Major surgery within the 4 weeks prior to initiation of study vaccine * Current use of immunosuppressive agents or systemic corticosteroids. Topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption) are allowed. Patients who have received systemic corticosteroids ≤ 30 days prior to starting study drug will be excluded * Patient is currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug * NOTE: Biomarker or tissue collection or any other non-interventional clinical trial enrollment is allowed * Must be 14 days between a non-study vaccine and any STEMVAC vaccination * NOTE: The minimum of 14 days does not apply to the tetanus and diphtheria (Td) vaccine * Any condition that may interfere with the patient's participation in the study per treating oncologist
Study sites (1)
WA
- Fred Hutch/University of Washington Cancer Consortium · Seattle, WA 98109Research Coordinator(s) · Study contact · 866-932-8588 · cvitrial@uw.eduNatasha Hunter, MD · Principal investigatorMore trials in Seattle