MATERIALS AND METHODSThis study is a prospective, multicenter, non-interventional, observational study designed to develop a

Spanish registry in Unresectable Locally Advance Breast Cancer (ULABC) and Metastatic Breast Cancer

(MBC) pts.

For this subset of pts, HER2 positivity was defined by immunohistochemistry [IHC] 3+ or IHC 2+ and in

situ hybridization [ISH]+, according to the valid American Society of Clinical Oncology/Collage of

American Pathologists guideline.

INCLUSION CRITERIA:

• Patients (females or males) diagnosed with ULABC or MBC (either after a disease recurrence or

as first diagnosis) from January 2016 to December 2019.

• Patients who died are allowed to be included.

• Patients who are able and willing to provide written informed consent.

• Age ≥ 18 years.

• Access to medical records and all data related to disease management.

STATISTICAL CONSIDERATIONS:

• This study is estimated to recruit 1,867 patients [1,305 (70%) Luminal, 336 (18%) HER2+ and 226

(12%) TN, based on the expected distribution of BC subtypes] in 38 Spanish sites throughout the

country.

• The analyses will be exploratory and primarily make use of descriptive statistical methods (i.e.

number, mean, median, standard deviation and range).

• Multivariate Cox analysis aiming to identify factors associated with overall survival (OS) were built.

The factors used were stage at 1st BC diagnosis, HR status, metastatic locations, age and

menopausal status at ABC diagnosis.

• Biological samples (primary and/or metastatic tumor tissue, and blood) collection is part of study

procedures (Results data not shown in this poster).

In this analysis (cut-off date 10/May/2021, database is ongoing), RESULTS

the features of 279 pts. + (i

IHQ] 3+, IHQ 2+ and in situ hybridization [ISH]+) tumors at any time of their ABC (5% after the 1st-line therapy). This subgroup has been evaluated because of the interest from a clinical perspective.

Multivariate Cox analysis aiming to identify factors associated with overall survival (OS) were built.2+

Features of HER2+ metastasic patients (pts) from a prospective registry of Advanced Breast

Cancer (ABC), GEICAM/2014-03 (RegistEM)Isabel Álvarez1,2, Ángel Guerrero-Zotano2,3, Josefina Cruz2,4, Purificación Martínez2,5, María Hernández2,6, César A. Rodríguez2,7, Álvaro Rodríguez-Lescure2,8, Silvia Antolín2,9, Encarna

Adrover2,10, Raquel Andrés2,11, Catalina Falo2,12, J. Ignacio Chacón2,13, Ana Miguel2,14, Sonia Servitja2,15, María Galán Gramaje2,16, Mireia Margelí Vila2,17, César Gómez Raposo2,18, Mª. José

Echarri2,19, Rafael Villanueva2,20, Ariadna Tibau Martorell2,21, Silvia Varela Ferreiro2,22, Ruth Campo2, Juan J. Miralles2, Susana Bezares2, Federico Rojo2,23,24, Sara López-Tarruella2,24,25

1.Unidad de Gestión del Cáncer de Guipúzcoa (Osakidetza-OSI Donostia_Onkologikoa)-BioDonostia, San Sebastián, Spain; 2.GEICAM, Spanish Breast Cancer Group, Madrid, Spain; 3.Fundación Instituto Valenciano de Oncologia (FIVO), Valencia, Spain; 4. Hospital

Universitario de Canarias, Santa Cruz de Tenerife, Spain; 5. Hospital Universitario Basurto, Bilbao, Spain; 6.Complejo Hospitalario Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria, Spain; 7.Hospital Universitario de Salamanca-IBSAL, Salmanaca,

Spain; 8.Hospital General Universitario de Elche, Alicante, Spain; 9. Complejo Hospitalario Universitario A Coruña (CHUAC), Galicia, Spain; 10. Hospital General Universitario de Albacete, Albacete, Spain; 11. Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain; 12.

ICO Hospitalet, Barcelona, Spain; 13. Hospital Virgen de la Salud, Toledo, Spain; 14. ALTHAIA Xarxa asistencial de Manresa, Barcelona, Spain; 15.Hospital del Mar, Barcelona, Spain; 16.Hospital Son Llátzer, Palma de Mallorca, Spain; 17.ICO-Badalona. B-ARGO (Badalona

Applied Research Group in Oncology), Barcelona, Spain; 18.Hospital Universitario Infanta Sofía, Madrid, Spain; 19. Hospital Universitario Severo Ochoa, Madrid, Spain; 20. Hospital de Sant Joan Despi Moises Broggi, Barcelona, Spain; 21. Hospital de la Santa Creu i Sant

Pau, Barcelona, Spain; 22. Hospital Universitario Lucus Augusti, Lugo, Spain; 23.Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain; 24. Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, Spain; 25.Hospital Universitario Gregorio

Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Universidad Complutense, Madrid, Spain

CONCLUSIONS

• In this cohort of HER2+ pts. de novo ABC was presented in 50% of

cases.

• de novo ABC was associated with better OS compared to recurrent

EBC. Younger age was also associated with better OS.

• HR status and menopausal status at ABC diagnosis were not

prognostic factors for OS.

OBJECTIVEIn this exploratory analysis (cut-off date 10/May/2021, database is ongoing), we describe the features

of 279 pts. with HER2+ tumors at any time of their ABC diagnosis.

This subgroup has been evaluated because of the interest from a clinical perspective.

REFERENCES

This presentation is the

intellectual property of the

authors.

Contact at:

secretaria-cientifica@geicam.org

for questions and permission

to reprint and/or distribute

P1-15-04

San Antonio Breast

Cancer Symposium

- December 7-10,

2021

ACKNOWLEDGMENTS

Copies of this poster obtained through Quick Response (QR)

Code are for personal use only and may not be reproduced

without permission from SABCS® and the author of this poste

INTRODUCTION• Breast Cancer (BC) is the most frequently cancer diagnosed in women. Several BC subtypes have

been described according to immunohistochemical (IHC)/in situ hybridization (ISH) definition (1,2).

• Advanced (A) BC continues being an incurable disease, with a median survival of 3 years and a 5-

year survival of 25% (3). Its management is complex and the involvement of all appropriate

professionals in a multidisciplinary team is essential.

• The RegistEM study is a non-interventional study that is providing prospective data from around 1,900

ABC pts. diagnosed with advanced disease between 01/Jan/2016 and 31/Dec/2019, either after

recurrence or at 1st diagnosis, in 38 Spanish sites representative of the national territory and whose

investigators are GEICAM members (ClinicalTrials.gov Identifier: NCT02819882).

We acknowledge all patients, investigators and

their teams and all GEICAM staff involved, for

their collaboration.

Roche Farma, Novartis Farmacéutica, Celgene

(a BMS company), AstraZeneca in alliance with

Daiichi Sankyo, Pfizer and Lilly collaborate in

the funding of this research study.

Table 1. Characteristics of HER2+ ABC by HR status and stage at

first BC diagnosis

1.Goldhirsch A, Winer EP, Coates AS, et al. Ann Oncol 2013

Sep;24(9):2206-23.

2.Sari E, Guler G, Hayran M, et al. Med Oncol 2011;28:57-63.

3.Dueñas EM, Hernández AL, Zotano AG, et al. Breast

Cancer Res Treat 2014;143(3):507-15.

4.Llort G, Chirivella I, Morales R, et al. Clin Transl Oncol.

2015 Dec;17(12):956-61.

*HR+ve

n=181

(67%)

HR-ve

n=91

(33%)

EBC

N=134

(48%)

ULABC or

de novo M1

N=145

(52%)

Total

N=279

Extension of advanced disease, n (%)

MBC 172 (95) 88 (97) 125 (93) 142 (98) 267 (96)

ULABC 9 (5) 3 (3) 9 (7) 3 (2) 12 (4)

Stage at first BC diagnosis, n (%)

EBC 87 (48) 41 (45) 134 (100) 0 134 (48)

de novo MBC 90 (50) 50 (55) 0 141 (97) 141 (51)

ULABC 4 (2) 0 0 4 (3) 4 (1)

Time in years to ABC in pts. with EBC at first diagnosis (n=134), n (%)

≤ 3 20 (23) 19 (46) 40 (30) 0 40 (30)

3 – 5 14 (16) 9 (22) 26 (19) 0 26 (19)

> 5 53 (61) 13 (32) 68 (51) 0 68 (51)

Age (years) at ABC diagnosis

Median 57 59 58 57 58

Min ; Max (33;89) (32;87) (32;89) (34;86) (32;89)

Menopausal status at ABC diagnosis, n (%)

Postmenopausal 127 (70) 66 (73) 102 (76) 96 (66) 198 (71)

Premenopausal 53 (29) 25 (28) 31 (23) 49 (34) 80 (29)

NA 1 (1) 0 1 (1) 0 1 (0)

Family history of BC and/or ovarian cancer, n (%)

Yes 59 (33) 24 (26) 42 (31) 43 (30) 85 (31)

No 109 (60) 61 (67) 81 (60) 93 (64) 174 (62)

Unknown 13 (7) 6 (7) 11 (8) 9 (6) 20 (7)

Pts. with any genetic analysis for hereditary risk*, n (%)

Yes 37 (21) 26 (30) 45 (35) 21 (15) 66 (25)

No 137 (79) 60 (70) 83 (65) 118 (85) 201 (75)

Pts. with BRCA1/2 genetic analysis, n (%)

Mutated 2 (15) 2 (33) 3 (23) 1 (14) 4 (20)

No Mutated 10 (77) 4 (67) 9 (69) 6 (86) 15 (75)

Inconclusive 1 (8) 0 1 (8) 0 1 (5)

Most frequent metastatic locations at ABC diagnosis, n (%)

Lymph Nodes 90 (50) 64 (70) 51 (38) 105 (72) 156 (56)

Bone 104 (58) 29 (32) 59 (44) 78 (54) 137 (49)

Liver 62 (34) 32 (35) 36 (27) 59 (41) 95 (34)

Lung 57 (32) 32 (35) 47 (35) 46 (32) 93 (33)

Soft Tissue 18 (10) 10 (11) 22 (16) 6 (4) 28 (10)

Brain 10 (6) 9 (10) 15 (11) 6 (4) 21 (8)

• HER2+ group represents the 15% of pts included at the cut-off date in the whole

database.

• In 5% of this pts the HER2 assessment was performed after the beginning of the

1st-line therapy.

• 7 of 279 pts. did not have any HR determined.

• Overall, visceral disease was present in 68% pts. and ≈75% pts. had ≤3 locations

(47% had ≤2) involved. At the cut-off date, 98% of pts. were white, there was only 1

male.

* According to the recommendations from the Spanish Society of Medical Oncology (4).

Figure 1. Most frequent therapies in 1st-, 2nd- and 3rd-

line by MoA according to HR status by number of pts (n)

0

10

20

30

40

50

60

70

80

90

1st Line 2nd Line 3rd Line

HR+

86

2 05

2 0

34

934 8

25

5 5 7

22

105

12 13

46

43

10

CT + dual anti-HER2 blockade + ET CT + single-agent HER2 blockade + ET

CT + dual anti-HER2 blockade CT + single-agent HER2 blockade

CT ET*

ET + HER2 blockade Anti-HER2 blockade

0

10

20

30

40

50

60

70

1st Line 2nd Line 3rd Line

HR-

3 0 00 0 0

64

40

6 4

15

3 3 52 0 11 1 07

36

5

CT + dual anti-HER2 blockade + ET CT + single-agent HER2 blockade + ET

CT + dual anti-HER2 blockade CT + single-agent HER2 blockade

CT ET*

ET + HER2 blockade Anti-HER2 blockade

HR+ve HR-ve Recurrent EBC ULABC or de novo M1

181 (67%) 91 (33%) 134 (48%) 145 (52%)

Number of Líne 1st 2nd 3rd 1st 2nd 3rd 1st 2nd 3rd 1st 2nd 3rd

n 180 93 56 90 49 26 133 85 52 144 63 33

Deaths, n 21 11 12 11 11 6 17 15 14 15 8 4

Table 2. Other relevant data according to HR status and type of ABC

• OS from ABC diagnosis to death or 31/12/2020

(censoring date): median of 61 months (95% CI 49-61).

• OS from ABC diagnosis to death or 31/12/2020

(censoring date) by HR status:

% of reported events: HR+ve 30%; HR-ve 41%.

Median (95% CI): HR+ve 61 (51-61); HR-ve 45 (35-NR)

• Multivariate Cox regression model for OS:

▪ Risk factors for worse OS:

o Recurrence from EBC compared to de novo

MBC (HR 1.950, 95% CI 1.264-3.008).

o Metastatic locations: visceral excluding brain

origin, brain, bone compared to soft tissue.

o Increase of age (HR 1.041, 95% CI 1.018-

1.065).

▪ HR status (+ve vs. -ve) and menopausal status at ABC

diagnosis were not statistically significant.

HR: hormone receptor; EBC: early breast cancer; ULABC: unresectable locally advanced breast cancer; M1: metastatic; mo: month; ET: endrocrine therapy; BT: biological therapy; CT:

chemotherapy; MoA: Mechanism of Action; OS: Overall Survival; NR: not reached.

*ET includes aromatase inhibitors or selective estrogen receptor degraders, as single-agents or combined with cyclin-dependent kinases 4/6 inhibitors.

*Dual anti-HER2 blockade refers only to monoclonal antibodies.

Figure 2. Overall Survival by HR

0 6 12 18 24 30 36 42 48 54 60

Time (months)

0

10

20

30

40

50

60

70

80

90

100

Surv

ival P

robabili

ty (

%)

logrank p-value: 0.066

-+RH

181 172 164 152 132 106 77 58 35 17 1 0+

90 86 82 73 62 51 35 25 13 5 0-

At Risk, n

Overall Survival by RH - (cut off 2020-12-31)Overall Survival by HR (censoring date 31st-Dec-2020)

*Death was reported in 34% of pts.