Recommended Neoadjuvant Treatment for Patients with
HER2-negative/HR-positive Breast Cancer
➤ Neoadjuvant chemotherapy can be used instead of adjuvant
chemotherapy in any patient with HR+, HER2-negative breast cancer
in whom the chemotherapy decision can be made without surgical
pathology data and/or tumor specific genomic testing. (Moderate
recommendation; IC-L)
➤ For postmenopausal patients with HR+, HER2-negative disease,
neoadjuvant endocrine therapy with an aromatase inhibitor may be
offered to increase locoregional treatment options. If there is no
intent for surgery, endocrine therapy may be used for disease control.
(Moderate recommendation; EB-B-I)
➤ For premenopausal patients with HR+, HER2-negative early-stage
disease, neoadjuvant endocrine therapy should not be routinely offered
outside of a clinical trial. (Moderate recommendation; EB-B-I)
Recommended Neoadjuvant Treatment for Patients with
HER2-Positive Disease
➤ Patients with node-positive or high-risk node-negative, HER2-positive
disease should be offered neoadjuvant therapy with an anthracycline
and taxane or non-anthracycline-based regimen in combination with
trastuzumab. Pertuzumab may be used with trastuzumab in the
neoadjuvant setting. (Strong recommendation; EB-B-H)
➤ Patients with T1a N0 and T1b N0, HER2+ disease should not be
routinely offered neoadjuvant chemotherapy or anti-HER2 agents
outside of a clinical trial. (Moderate recommendation; IC-I)
Recommendation Grading
Type Benefit/harm Evidence Quality
Strength of
Recommendation
EB Evidence-
based
B Benefits
outweigh harms
H High Strong
CB
Consensus-
based
H Harms
outweigh
benefits
I Intermediate Moderate
IC Informal
consensus
B/H Relative balance
of benefits and
harms
L Low Weak
Ins Insufficient
New Recommendation from 2022 Guideline Rapid
Recommendation Update
➤ For patients with T1cN1-2 or T2-4N0 (stage II or III), early-stage triple
negative breast cancer, the Panel recommends use of pembrolizumab
(200 mg every 3 weeks or 400 mg every 6 weeks) in combination with
neoadjuvant chemotherapy, followed by adjuvant pembrolizumab after
surgery. Adjuvant pembrolizumab may be given either concurrent with
or after completion of radiation therapy. Given that immune-related
adverse events (irAEs) associated with pembrolizumab therapy can
be severe and permanent, careful screening for and management of
common toxicities are required. The ASCO guideline for management
of irAEs in patients treated with immune checkpoint inhibitor therapy
offers detailed practice recommendations and should be consulted
by clinicians who prescribe pembrolizumab for patients with early-
stage TNBC, https://ascopubs.org/doi/full/10.1200/JCO.21.01440.
(Moderate recommendation; EB-B-I)
Qualifying Statements: Results from KEYNOTE-522 are based on continued
pembrolizumab in the adjuvant setting. There is uncertainty concerning the optimal
adjuvant treatment given independent benefits of capecitabine in TNBC and olaparib in
patients with germline BRCA mutations without pembrolizumab. There are no data to
support the use of pembrolizumab in combination with either capecitabine or olaparib.
