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Breast 1 2021 082720
Breast 1 2021 082720
Breast 1 2021 082720
BINV-N (3 of 4): In the row for the 12-gene assay it The panel consensus did not support the inclusion
states “Low (<3.33)” and “High (>3.33)”. Request this be of the other specific changes requested.
changed to “EPclin Low (≤3.3)” and “EPclin High (>3.3)”.
The 12-gene test reports an EP molecular score and an See Submissions for references.
EPclin score. It is important and accurate to clarify EPclin
and to state “3.3” (not “3.33) and include “≤” and “>” in
the correct locations.
Submission from Novartis on 05/12/20 to consider the “If there is disease progression while on a CDK4/6
following requests: or PI3K inhibitor, there are limited data to support
an additional line of therapy with another CDK4/6-
• Consider adding “For PIK3CA-mutated tumors, see or PIK3CA-containing regimen…”
additional targeted therapy options (see BINV-R)” to
the list of Preferred Regimens for First-Line Therapy The panel consensus did not support the inclusion 0 28 0 3
as a systemic treatment option for HR+/HER2- of the other specific changes requested.
recurrent or Stage IV breast cancer in BINV-P.
• Consider adding the footnote “If there is disease
progression while on an alpelisib-containing regimen,
there are no data to support an additional line of See Submission for references.
therapy with another alpelisib regimen” to the bullet
“For PIK3CA-mutated tumors...” under the list of
Preferred Regimens for Second- and Subsequent-
Line Therapy.
• Consider changing the NCCN Category of
Preference for alpelisib + fulvestrant to “Preferred”
instead of “Preferred second-line therapy” in BINV-R.
BINV-Q/BINV-R Based on a review of the data and discussion, the 28 0 0 3
External request: panel consensus supported the inclusion of
pembrolizumab + chemotherapy (albumin-bound
Submission from Merck & Co., Inc., on 05/29/20 and paclitaxel, paclitaxel, or gemcitabine and
11/16/20 to consider the addition of pembrolizumab in carboplatin) as an option for those with recurrent or
combination with chemotherapy as a first-line therapy stage IV (M1) triple negative breast cancer, if PD-
regimen for patients with locally recurrent inoperable or L1 positive with a combined positive score > 10.
metastatic triple-negative breast cancer. This is a category 1, preferred first-line therapy
option.
Reference:
Cortes J, Cescon DW, Rugo HS, et al. KEYNOTE-
355: Randomized, double-blind, phase 3 study of
pembrolizumab + chemotherapy versus placebo +
chemotherapy for previously untreated locally
recurrent inoperable or metastatic triple-negative
breast cancer. Presented at ASCO 2020; May 29,
2020; Abstract 1000.
NCCN Guidelines for Breast Cancer V.1.2021 – Annual on 08/27/20