| Eligibility |
Inclusion Criteria:
Patients are eligible to be included in the trial only if all of the following criteria
apply:
1. The patient (or legally acceptable representative if applicable) provides written
informed consent for the trial.
2. Female = 18 years of age on the day of informed consent signing.
3. Histologically confirmed triple negative breast cancer is defined as estrogen receptor
(ER), progesterone receptor (PR), and HER2 negative. ER/PR negativity is defined as
<10% IHC staining of any intensity.
HER2 negativity is defined as the following per the 2018 American Society of Clinical
Oncology and College of American Pathologists guidelines.
4. Refractory to standard neoadjuvant anthracycline-containing chemotherapy regimen,
demonstrated on MRI.
5. Bilateral breast cancers that individually meet eligibility criteria are allowed.
6. Prior immunotherapy treatment allowed. 7. Eastern Cooperative Oncology Group (ECOG)
performance status of 0 or 1. 8. Adequate organ function as defined in Table 1. All
screening labs should be performed within 28 days of trial treatment initiation.
9. Cardiac ejection fraction =45%. 10. A female patient is eligible to participate if she
is not pregnant, not breastfeeding, and at least one of the following conditions applies:
1. Not a woman of childbearing potential (WOCBP) OR
2. A WOCBP who agrees to follow the contraceptive guidance in during the treatment period
and for at least 120 days after the last dose of trial treatment. WOCBP must have a
negative serum pregnancy test (ß-human chorionic gonadotropin [ß-HCG]) within 72 hours
prior to trial treatment administration.
11. Willing to provide biopsy tissue as required by the trial. 12. Willing and able to
comply with the protocol for the duration of the trial including undergoing treatment
and scheduled visits and examinations.
Exclusion Criteria:
1. History of poorly controlled hypertension (defined as systolic blood pressure
>150 mmHg). Patients whose hypertension has been well controlled on the same
treatment for 1 year prior to Cycle 1, Day 1 are eligible. Only patients on
single-agent antihypertensive therapy are allowed.
2. History of New York Heart Association class III or greater cardiac disease.
3. History of myocardial infarction, stroke, ventricular arrhythmia, or greater than
first-degree conduction defect within the past 12 months.
4. History of congenital QT prolongation.
5. Absolute corrected QT interval of >480 msec in the presence of potassium >4.0
mEq/L and magnesium >1.8 mg/dL.
6. Is currently participating in or has participated in a study of an
investigational agent or has used an investigational device within 4 weeks prior
to trial treatment administration.
NOTE: Patients who have entered the follow-up phase of an investigational study may
participate as long as it has been 4 weeks after the last dose of the previous
investigational agent.
8. Concurrent use of any complementary or alternative medicines. 9. Concurrent use of
inhibitors or inducers of cytochrome P450 (CYP)3A4 and CYP2D6 10. Has a diagnosis of
immunodeficiency or is receiving chronic systemic steroid therapy (dose exceeding 10
mg daily of prednisone equivalent) or any other form of immunosuppressive therapy
within 7 days prior to trial treatment administration.
11. Known history of active tuberculosis (Bacillus Tuberculosis). 12. Known or
suspected hypersensitivity to any component or excipient of the proposed regimen
(docetaxel chemotherapy, gene vector, pembrolizumab).
13. Patients must have recovered from all AEs due to previous therapies to = Grade 1
or baseline. Patients with = Grade 2 neuropathy may be eligible. If patient received
major surgery, she must have recovered adequately from the toxicity and/or
complications from the intervention prior to starting the trial treatment.
14. Known additional malignancy that is progressing or requires active treatment.
NOTE: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the
skin, or cervical cancer in situ that have undergone potentially curative therapy are
not excluded.
15. Active autoimmune disease that has required systemic treatment in the past 2 years
(i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive
drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
form of systemic treatment.
16. History of (noninfectious) pneumonitis that required steroids or current
pneumonitis.
17. Active infection requiring systemic therapy. 18. History or current evidence of
any condition, therapy, or laboratory abnormality that might confound the results of
the trial, interfere with the patient's participation for the full duration of the
trial, or is not in the best interest of the patient to participate, in the opinion of
the treating investigator.
19. Known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
20. Pregnant or breastfeeding, or expecting to conceive children within the projected
duration of the trial, starting with the prescreening or screening visit through 120
days after the last dose of trial treatment.
21. Known history of human immunodeficiency virus (HIV). 22. Known history of
hepatitis B (defined as hepatitis B surface antigen reactive) or known active
hepatitis C virus (HCV; defined as HCV RNA [qualitative] is detected) infection.
23. Received a live vaccine within 30 days prior to trial treatment administration.
Examples of live vaccines include, but are not limited to, the following: measles,
mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus
Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are
generally killed virus vaccines and are allowed; however, intranasal influenza
vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
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