This document provides a pathology report for a 34-year-old female patient. It summarizes the findings from biopsies of the right and left breast. For the right breast, it finds an invasive ductal carcinoma measuring 1.5 x 1.3 x 1 cm. Three of 39 lymph nodes from the right axilla showed metastatic carcinoma. The left breast tissue showed benign findings with no evidence of malignancy. The conclusion is infiltrating ductal carcinoma of the right breast with metastasis to 3 lymph nodes, classified as T1c/N1a.

1. DR. R. RAJKUMAR D.M.
CONSULTANT MEDICAL ONCOLOGIST
VELAMMAL MEDICAL COLLEGE &
HOSPITAL

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12. MC-4406
DEPARTMENT OF PATHOLOGY
APCC-QRF-HP-009
W/BNo/RefNo
Gender
Age
Dr.SELVI RADHAKRISHNAN
Page 12 of 4
28-JAN-2023 01:00:11 PM 03-FEB-2023 05:11:56 PM
Received on : Reported on :
Collected on : 27-JAN-2023 08:22:54 PM
: Discharged
: 34Yr : Female
Name
UHID
Lab No
Ref Doctor
: Mrs. VERONICA POTHY POTHIRAJ
:
:
:
AC12.0000021092 / CPCIP10154
APCC1.H2300168 LRN : 12667103
HISTOPATHOLOGY TEST [LARGE] (TEST METHOD - LIGHT MICROSCOPY AND WSI WITH INTERPRETATION)
Brief Clinical History:
The patient is a 34 year old woman with a right breast carcinoma diagnosed on a prior core biopsy.
Operative procedure: Right mastectomy with axillary clearance and left side reduction
mammoplasty.
Specimen:
1) MAIN SPECIMEN, RIGHT MASTECTOMY.
2) RIGHT AXILLARY CLEARANCE.
3) LEFT REDUCTION SPECIMEN.
Macroscopic Description:
The specimen is received in 3 formalin filled containers each labelled with patient's name and UHID
(AC12.0000021092).
The container #1 is designated as "Right mastectomy specimen (stich on lateral end)" and it holds
right side total mastectomy specimen measuring 15 x 14 x 6 cm, and weighting 497 grams, skin
flap measuring 5.5 x 5.5 x 0.5 cm. Nipple areola measuring 2.2 x 2.5 x 1.1 cm. The specimen is
inked and serial sections from medial to lateral. On cut surface grey tan nodule seen measuring 1.5
x 1.3 x 1 cm. The ? lesion seen at outer upper quadrant. The clearance is 1 cm from posterior
margin 0.6 cm from anterior margin. Rest of breast shows multiple grey white area.
A1 - Nipple areola
A2 - ? Lesion with posterior margin

13. MC-4406
DEPARTMENT OF PATHOLOGY
APCC-QRF-HP-009
W/BNo/RefNo
Gender
Age
Dr.SELVI RADHAKRISHNAN
Page 13 of 4
Reported on 03-FEB-2023 05:11:56 PM
Received on 28-JAN-2023 01:00:11 PM
27-JAN-2023 08:22:54 PM
Collected on : :
:
: Discharged
: 34Yr : Female
Name
UHID
Lab No
Ref Doctor
: Mrs. VERONICA POTHY POTHIRAJ
:
:
:
AC12.0000021092 / CPCIP10154
APCC1.H2300168 LRN : 12667103
A3 - ? Lesion
A4 - Outer upper quadrant
A5 - Outer lower quadrant
A6 - Inner upper quadrant
A7 - Inner lower quadrant
The container #2 is designated as "Right axillary clearance" and it holds single fragment of
fibrofatty tissue measuring 9 x 8 x 4 cm.
B1 - B14 - 6 lymph nodes.
The container #3 is designated as "Left reduction specimen" and it holds single skin with fibrofatty
tissue measuring 5 x 2 x 1 cm.
C1 - C3 - Partially embedded.
Grossed by: Dr.Sushama/ Navin
Microscopic Description:
Sections from the right breast show an invasive ductal carcinoma composed of neoplastic cells
arranged in a predominantly nodular and syncytial pattern. The cells infiltrate predominantly as
nests and loosely cohesive clusters. The tumor cells are arranged in a back to back pattern with
dense peritumoral lymphoid reaction at the invasive tumor front.

14. MC-4406
DEPARTMENT OF PATHOLOGY
APCC-QRF-HP-009
W/BNo/RefNo
Gender
Age
Dr.SELVI RADHAKRISHNAN
Page 14 of 4
Reported on 03-FEB-2023 05:11:56 PM
Received on 28-JAN-2023 01:00:11 PM
27-JAN-2023 08:22:54 PM
Collected on : :
:
: Discharged
: 34Yr : Female
Name
UHID
Lab No
Ref Doctor
: Mrs. VERONICA POTHY POTHIRAJ
:
:
:
AC12.0000021092 / CPCIP10154
APCC1.H2300168 LRN : 12667103
The tumor cells are round to regular and show vesicular nuclei with prominent nucleoli. Mitoses are
infrequent and at the infiltrating front, a mitotic count ranges from 8 - 9 per 10 hpf. The uninvolved
breast parenchyma shows predominantly stromal hyalinization and few atrophic appearing acinar
and ductal profiles along with sclerosis adenosis. Lymphatic emboli and perineural invasion are not
evident. Deep margin is free of tumor with a clearance of 1 cm. Nipple and areolar free of tumor.
A total of 39 lymph nodes are evaluated from the right axillary dissection sample and 3 nodes show
metastatic carcinoma. There is no evidence of extranodal extension. The largest deposit measures
14 mm in maximum dimension.
Sections studied from the left breast show benign breast tissue with bland appearing duct epithelial
cells there is no evidence of atypia or malignancy.
IMPRESSION:
BREAST, RIGHT SIDE, MASTECTOMY -
INFILTRATING DUCTAL CARCINOMA, NOS
MAXIMUM TUMOR DIMENSION 1.5 X 1.3 X 1 CM
HISTOLOGIC GRADE (TUB3 + NUC3 + MIT2, SCORE OF 8/9) BY ESBR CRITERIA.
MITOTIC INDEX - 9 PER 10 HIGH POWER FIELDS.
PERITUMOURAL LYMPHOID RESPONSE HIS BRISK AT THE INFILTRATING EDGE OF THE
TUMOR.
NO LYMPHATIC EMBOLI OR PERINEURAL INVASION

15. MC-4406
DEPARTMENT OF PATHOLOGY
APCC-QRF-HP-009
W/BNo/RefNo
Gender
Age
Dr.SELVI RADHAKRISHNAN
28-JAN-2023 01:00:11 PM 03-FEB-2023 05:11:56 PM
Received on : Reported on :
Collected on : 27-JAN-2023 08:22:54 PM
: Discharged
: 34Yr : Female
Name
UHID
Lab No
Ref Doctor
: Mrs. VERONICA POTHY POTHIRAJ
:
:
:
AC12.0000021092 / CPCIP10154
APCC1.H2300168 LRN : 12667103
NO MICROCALCIFICATIONS OR DCIS.
NIPPLE AND AREOLA FREE OF TUMOR.
UNINVOLVED BREAST PARENCHYMA SHOWS FIBROSIS AND SCLEROSING ADENOSIS.
POSTERIOR RESECTION MARGIN CLEARANCE 1 CM.
LYMPH NODES, RIGHT AXILLA, DISSECTION -
METASTATIC CARCINOMA IN 3 OF 39 NODES (3/39)
TUMOR DEPOSIT MEASURES 14 MM IN MAXIMUM DIMENSION
NO EXTRANODAL EXTENSION.
BREAST, LEFT SIDE, REDUCTION MAMMOPLASTY -
BENIGN BREAST TISSUE WITH NO EVIDENCE OF EPITHELIAL ATYPIA OR MALIGNANCY.
PATHOLOGIC STAGING: T1c / N1a.
(STAGING INFORMATION PROVIDED HERE IS TENTATIVE ONLY AND MAY CHANGE AFTER
INTEGRATION OF CLINICAL DATA)
* END OF REPORT *
DR SUSHAMA V PATIL MD USA
PATHOLOGIST
Typed By:
Page 15 of 4
1158068
Printed On : 03-FEB-2023 08:12:45 PM

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27. Heterogeneity of Triple-Negative Breast Cancer
Adapted from Cancer Discovery, ©2019, volume 9(issue 2), p. 176-198, Garrido-Castro et al, “Insights into Molecular
Classifications of Triple-Negative Breast Cancer: Improving Patient Selection for Treatment,” with permission from AACR.
AR positive
Transcriptome Proteome Genome Epigenome Immune BRCA Related
TNBC
Lack of ER, PgR, and HER2 by IHC/FISH
PAM50 subtypes
TNBC types
Integrative
clusters
Surface epithelial
Cytosolic/nuclear
PDJ amplicon
Stromal axes
BRCA1/2 mutant
(germline or somatic)
Inflamed,
excluded,
desert
Hypermutation
MMR deficiency
APOBEC
Immune environment
characterization
Luminal/nonluminal
Methylation signatures
BRCAness
BRCA1 promoter
HRD score
Basal (IHC/PAM50)
Tumor BRCA
Mut/CNA pathways
(P13K/AKT/mTOR, RTKs
JAK/STAT, NOTCH)
Mutational signatures

28. Rationale for Immune Checkpoint Inhibition in TNBC
Tumor-Infiltrating
Lymphocytes1
Nonsynonymous Mutations3
PD-L1 Expression2
TILs
(%)
100
0
80
60
40
20
Overall ER+/HER2- HER2+ ER-/HER2-
Subtype
Str-Ly
inTu-Ly
Log
2
100
0
80
60
40
20
Non-TNBC TNBC
P <.001
Number
of
SNVs
per
Exome
100
0
80
60
40
20
Luminal A Luminal B HER2E Basal-like
Subtype
160
140
120
P <.001**
1. Loi. JCO. 2013;31:860. 2. Mittendorf. Cancer Immunol Res. 2014;2:361. 3. Luen. Breast. 2016;29:241.

29. KEYNOTE-5221 I-SPY 22 NEOTRIP3 IMpassion0314 GeparNuevo5
ICI Pembrolizumab Pembrolizumab Atezolizumab Atezolizumab Durvalumab
Target PD-1 PD-1 PD-L1 PD-L1 PD-L1
Patients, n/N 602/1174 69/181 280 333 174
Stage II/III II/III Included N3 II/III 35% stage I
Anthracycline Yes Yes No Yes Yes
Carboplatin Yes No Yes No No
pCR rate
(P value)
65% vs 51%
P = .00055
60% vs 22%
(graduated)
49% vs 44%
P = .48
58% vs 41%
P = .0044
53% vs 44%
P = .287
Role of Immunotherapy in Early-Stage TNBC
 Anthracyclines and stage are key factors determining benefit from neoadjuvant ICI therapy
 PD-L1 status does not matter when immune system is intact
 Other variables such as tumor-infiltrating lymphocytes may play a role
1. Dent. ESMO Asia 2020. Abstr 10. 2. Yee. ASCO 2022. Abstr 362. 3. Gianni. Ann Oncol. 2022;33:534.
4. Mittendorf. Lancet. 2020;396:1090. 5. Denkert. ASCO 2022. Abstr. 583.

30. KEYNOTE-522: Pembrolizumab + Chemotherapy for
Newly Diagnosed, Early-Stage TNBC
 Randomized, placebo-controlled phase III trial
‒ Median f/u: 39.1 mo (range: 30.0-48.0); data cutoff: March 23, 2021
Patients aged ≥18 yr with
newly diagnosed T1c N1-2
or T2-4 N0-2 TNBC; ECOG
PS 0/1; tissue sample
available for PD-L1 testing
(N = 1174)
Placebo Q3W +
Carboplatin*/Paclitaxel† (C1-4) +
Doxo‡/Epirubicin¶/Cyclophosphamide§ (C5-8)
(n = 390)
Pembrolizumab 200 mg Q3W +
Carboplatin*/Paclitaxel† (C1-4) +
Doxo‡/Epirubicin¶/Cyclophosphamide§ (C5-8)
(n = 784)
Pembrolizumab
200 mg Q3W (C1-9)
Placebo
Q3W (C1-9)
Neoadjuvant Phase Adjuvant Phase
2:1
Stratified by nodal status (+/-),
tumor size (T1/T2 vs T3/T4), carboplatin schedule (QW vs Q3W)
*AUC 5 Q3W or AUC 1.5 Q1W.
†80 mg/m2 Q1W.
‡60 mg/m2 Q3W.
¶90 mg/m2 Q3W.
§600 mg/m2 Q3W.
 Primary endpoints: pCR (ypT0/Tis ypN0) by local review, EFS by local review
 Secondary endpoints: pCR (ypT0 ypN0 and ypT0/Tis), OS, EFS (PD-L1+), safety, QoL
 Exploratory endpoints: RCB, pCR by subgroups, EFS by pCR
24 wk
Surgery
Surgery
27 wk
Pusztai. ASCO 2022. Abstr 503. Schmid. NEJM. 2022;386:556.

31. KEYNOTE-522: PD-L1 Did Not Predict Benefit From
Pembrolizumab
Dent. ESMO Asia 2020. Abstr 10. Schmid. NEJM. 2020;382:810.
ypT0/Tis ypN0
pCR,
%
(95%
CI)
100
90
80
70
60
50
40
30
20
10
0
pCR in ITT Population
(ypT0/Tis ypN0)
∆ 13.6 (5.4 to 21.8)
P = .00055
64.8%
51.2%
Pembro + chemo
Placebo + chemo
260/401 103/201
PD-L1 Positive
pCR,
%
(95%
CI)
100
90
80
70
60
50
40
30
20
10
0
∆ 14.2 (5.3 to 23.1)
68.9%
54.9%
230/334 90/164
∆ 18.3 (-3.3 to 36.8)
45.3%
30.3%
29/64 10/33
PD-L1 Negative
pCR by PD-L1 Status

32. KEYNOTE-522: EFS at IA4
Schmid. NEJM. 2022;386:556.
Events, % HR (95% CI)
Pembro + chemo 15.7 0.63
(0.48-0.82;
P <.001*)
Placebo + chemo 23.8
Median follow-up: 39.1 mo
(data cutoff: March 23, 2021)
EFS
(%)
Mo
Patients at Risk, n
Pembro + chemo
Placebo + chemo
*Crossed prespecified
boundary of P = .01034.
784
390
781
386
769
382
751
368
728
358
718
342
702
328
692
319
681
310
671
304
652
297
551
250
433
195
303
140
165
83
28
17
0
0
0
0
84.5%
76.8%
100
80
60
40
20
0
51
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48

33. KEYNOTE-522: EFS by pCR
pCR Yes
HR: 0.73 (95% CI: 0.39-1.36)
pCR No
HR: 0.70 (95% CI: 0.52-0.95)
Mo
Schmid. NEJM. 2022;386:556.
100
80
60
40
20
0
33
0 3 6 9 12 15 18 21 24 27 30 36 39 42 45 48 51
EFS
(%)
Pembrolizumab-CT responder
Placebo-CT responder
Pembrolizumab-CT nonresponder
Placebo-CT nonresponder
94.4%
92.5%
67.4%
56.8%

34. IMpassion031: Addition of Atezolizumab to
Neoadjuvant Chemotherapy in Stage II-III TNBC
 Randomized, double-blind, placebo-controlled phase III trial
Atezolizumab +
nab-paclitaxel
12 wk
Patients with previously
untreated stage II/III
TNBC; tumor >2 cm;
PD-L1 status by IHC
(N = 333) Placebo +
nab-paclitaxel
12 wk
 Primary endpoint: pCR using AJCC staging system in ITT population and
PD-L1+ subpopulation
 Key secondary endpoints: EFS, DFS, OS in all patients and PD-L1+ subpopulation, safety
Stratified by disease stage (stage II vs stage III),
PD-L1 IC status (≥ 1% vs <1%)
Atezolizumab + doxorubicin
+ cyclophosphamide
8 wk
Placebo + doxorubicin
+ cyclophosphamide
8 wk
Surgery
Atezolizumab
11 doses
Surgery Observation
Mittendorf. Lancet. 2020;396:1090. Harbeck. ESMO 2020. Abstr LBA11. NCT03197935.

35. IMpassion031: Pathologic Complete Response in ITT
Population
pCR (95% CI), ypT0/is ypN0
58%
41%
95/165 69/168
Δ 16.5%
Atezo + CT
0
20
40
60
80
100
pCR,
%
(95%
CI)
Mittendorf. Lancet. 2020;396:1090. Harbeck. ESMO 2020. Abstr LBA11.
Pbo + CT
P = .0044
n/N =

36. Slide credit: clinicaloptions.com
IMpassion031: pCR by PD-L1 Status
Mittendorf. Lancet. 2020;396:1090. Harbeck. ESMO 2020. Abstr LBA11.
PD-L1 Positive
69%
49%
53/77 37/75
Δ 19.5%
Atezo + CT
0
20
40
60
80
100
pCR,
%
(95%
CI)
Pbo + CT
n/N =
PD-L1 Negative
48%
34%
42/88 32/93
Δ 13.3%
Atezo + CT
0
20
40
60
80
100
pCR,
%
(95%
CI)
Pbo + CT
n/N =

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