This is a randomized open-label phase 2 study to evaluate the efficacy and safety (as assessed by pCR) of the NANT Neoadjuvant TNBC Vaccine regimen (experimental arm) compared to the SoC dose-dense regimen of doxorubicin/cyclophosphamide followed by paclitaxel (control arm).
Treatment will be administered in 2 phases, a neoadjuvant phase and a postoperative phase. The neoadjuvant phase will be 18 weeks for patients enrolled in the experimental arm and 16 weeks for those enrolled in the control arm. Following the neoadjuvant phase, all subjects will undergo determination of their current response status and appropriate breast surgery and node dissection after which assessment for pCR will be conducted following completion of neoadjuvant systemic therapy. Pathologists interpreting surgical specimens for pCR assessment will be blinded to the treatment arm. All subjects, regardless of whether or not they have achieved a pCR, will then enter the postoperative phase where they will receive adjuvant treatment. A small portion of the corresponding neoadjuvant therapy, either nab-paclitaxel or paclitaxel, will be administered as adjuvant treatment postoperatively. Adjuvant treatment will continue in the postoperative phase until the subject experiences unacceptable toxicity (not correctable with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt
5-fluoro-2,4 (1H,3H)-pyrimidinedione
albumin-binding prodrug of doxorubicin HCl
Chan Soon-Shiong Institute for Medicine
El Segundo, California, United States
Pathological Complete Response Rate
Compare the efficacy of the NANT neoadjuvant TNBC Vaccine treatment vs standard-of-care (SoC) therapy as assessed by pathologic complete response (pCR) rate in the breast and axilla.
Time frame: 8 months
Evaluation of safety as determined by incidence or treatment-emergent adverse events
Incidence of treatment -emergent adverse events
Time frame: 36 months
Evaluate additional measures of efficacy by event-free survival
Time from randomization to first occurrence of advancement of disease
Time frame: 36 months
Overall survival
Time from date of first treatment to death from any cause
Time frame: 36 months
Locoregional relapse
Presence of any disease recurrence, including location
Time frame: 36 months
Distant metastatic rates at 1 year
Number of patients with a metastatic lesion
Time frame: 36 months
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Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
Ad5 \[E1-, E2b-\]-CEA
Ad5 \[E1-, E2b-\]-Brachyury vaccine
Ad5 \[E1-, E2b-\]-mucin 1\[MUC1\]
Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
CEA yeast vaccine
Brachyury yeast vaccine
Avelumab
Recombinant human super agonist interleukin-15 (IL-15) complex
NK-92 \[CD16.158V, ER IL-2\]
2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
Doxorubicin HCL
paclitaxel