World J Oncol

World Journal of Oncology, ISSN 1920-4531 print, 1920-454X online, Open Access

Article copyright, the authors; Journal compilation copyright, World J Oncol and Elmer Press Inc

Journal website https://wjon.elmerpub.com

Original Article

Volume 000, Number 000, August 2025, pages 000-000

Neoadjuvant Chemotherapy Plus Denosumab Compared to Chemotherapy Alone in Hormonal Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Premenopausal Breast Cancer Patients

**Table 1.** Baseline Characteristics Between the Two Groups
Parameters	Control (n = 26)	Experimental (n = 24)	Total	P value
ER: estrogen receptor; PR: progesterone receptor; ECOG: Eastern Cooperative Oncology Group.
Age at diagnosis
≤ 40 years	10 (38.5%)	8 (33.3)	18 (36)	0.77
> 40 years	16 (61.5%)	16 (66.7%)	32 (64.0%)
Pathological type
Invasive ductal carcinoma	24 (92.3%)	24 (100.0%)	48 (96.0%)	0.49
Others	2 (7.7%)	0 (0.0%)	2 (4.0%)
ER%
ER ≤ 50%	4 (15.4%)	4 (16.7%)	8 (16.0%)	0.92
ER > 50%	22 (84.6%)	20 (83.3%)	42 (84.0%)
Allred score
4 - 6	6 (23.1%)	4 (16.7%)	10 (20.0%)	0.73
> 6	20 (76.9%)	20 (83.3%)	40 (80.0%)
PR status
Negative	4 (15.4%)	5 (20.8%)	9 (18.0%)	0.72
Positive	22 (84.6%)	19 (79.2%)	41 (82.0%)
PR%
PR ≤ 50%	12 (46.2%)	14 (58.3%)	26 (52.0%)	0.41
PR > 50%	14 (53.8%)	10 (41.7%)	24 (48.0%)
Ki67
≤ 20%	6 (30.0%)	5 (23.8%)	11(26.8%)	0.73
> 20%	14 (70.0%)	16 (76.2%)	30 (73.2%)
ECOG performance status (PS)
0	26 (100.0%)	21 (87.5%)	47 (94.0%)	0.1
1	0 (0.0%)	3 (12.5%)	3 (6.0%)
Clinical-T
T1	1 (3.8%)	0 (0.0%)	1 (2.0%)	0.46
T2	9 (34.6%)	13 (54.2%)	22 (44.0%)
T3	3 (11.5%)	2 (8.3%)	5 (10.0%)
T4	13 (50.0%)	9 (37.5%)	22 (44.0%)
Clinical T-categories
T1-3	13 (50.0%)	15 (62.5%)	28 (56.0%)	0.41
T4	13 (50.0%)	9 (37.5%)	22 (44.0%)
Clinical N-categories
NX	1 (3.8%)	0 (0.0%)	1 (2.0%)	0.37
N0	4 (15.4%)	3 (12.5%)	7 (14.0%)
N1	21 (80.8%)	18 (75.0%)	39 (78.0%)
N2	0 (0.0%)	1 (4.2%)	1 (2.0%)
N3	0 (0.0%)	2 (8.3%)	2 (4.0%)
Clinical N-categories
Negative	4 (15.4%)	3 (12.5%)	7 (14.0%)	0.77
Positive	22 (84.6%)	21 (87.5%)	43 (86.0%)
Clinical stage
II	11 (42.3%)	12 (50.0%)	23 (46.0%)	0.78
III	15 (57.7%)	12 (50.0%)	27 (54.0%)

Table 1. Baseline Characteristics Between the Two Groups

Parameters

Control (n = 26)

Experimental (n = 24)

Total

P value

ER: estrogen receptor; PR: progesterone receptor; ECOG: Eastern Cooperative Oncology Group.

Age at diagnosis

≤ 40 years

10 (38.5%)

8 (33.3)

18 (36)

0.77

> 40 years

16 (61.5%)

16 (66.7%)

32 (64.0%)

Pathological type

Invasive ductal carcinoma

24 (92.3%)

24 (100.0%)

48 (96.0%)

0.49

Others

2 (7.7%)

0 (0.0%)

2 (4.0%)

ER%

ER ≤ 50%

4 (15.4%)

4 (16.7%)

8 (16.0%)

0.92

ER > 50%

22 (84.6%)

20 (83.3%)

42 (84.0%)

Allred score

4 - 6

6 (23.1%)

4 (16.7%)

10 (20.0%)

0.73

> 6

20 (76.9%)

20 (83.3%)

40 (80.0%)

PR status

Negative

4 (15.4%)

5 (20.8%)

9 (18.0%)

0.72

Positive

22 (84.6%)

19 (79.2%)

41 (82.0%)

PR%

PR ≤ 50%

12 (46.2%)

14 (58.3%)

26 (52.0%)

0.41

PR > 50%

14 (53.8%)

10 (41.7%)

24 (48.0%)

Ki67

≤ 20%

6 (30.0%)

5 (23.8%)

11(26.8%)

0.73

> 20%

14 (70.0%)

16 (76.2%)

30 (73.2%)

ECOG performance status (PS)

26 (100.0%)

21 (87.5%)

47 (94.0%)

0.1

0 (0.0%)

3 (12.5%)

3 (6.0%)

Clinical-T

1 (3.8%)

0 (0.0%)

1 (2.0%)

0.46

9 (34.6%)

13 (54.2%)

22 (44.0%)

3 (11.5%)

2 (8.3%)

5 (10.0%)

13 (50.0%)

9 (37.5%)

22 (44.0%)

Clinical T-categories

T1-3

13 (50.0%)

15 (62.5%)

28 (56.0%)

0.41

13 (50.0%)

9 (37.5%)

22 (44.0%)

Clinical N-categories

1 (3.8%)

0 (0.0%)

1 (2.0%)

0.37

4 (15.4%)

3 (12.5%)

7 (14.0%)

21 (80.8%)

18 (75.0%)

39 (78.0%)

0 (0.0%)

1 (4.2%)

1 (2.0%)

0 (0.0%)

2 (8.3%)

2 (4.0%)

Clinical N-categories

Negative

4 (15.4%)

3 (12.5%)

7 (14.0%)

0.77

Positive

22 (84.6%)

21 (87.5%)

43 (86.0%)

Clinical stage

11 (42.3%)

12 (50.0%)

23 (46.0%)

0.78

III

15 (57.7%)

12 (50.0%)

27 (54.0%)

**Table 2.** The Main Different Parameters Between the Two Groups
Parameters	Control, n = 24	Experimental, n = 24	Total	P value
BCS: breast conservative surgery; RCB: residual cancer burden.
RCB
0	2 (8.3%)	0 (0.0%)	2 (4.2%)	0.22
I	4 (16.7%)	5 (20.8%)	9 (18.8%)
II	12 (50.0%)	8 (33.3%)	20 (41.7%)
III	6 (25.0%)	11 (45.8%)	17 (35.4%)
RCB
0-I	6 (25.0%)	5 (20.8%)	11 (22.9%)	0.73
II-III	18 (75.0%)	19 (79.2%)	37 (77.1%)
Type of surgery
BCS	14 (58.3%)	14 (58.3%)	28 (58.3%)	1.0
MRM	10 (41.7%)	10 (41.7%)	20 (41.7%)
Pathological-T
T0	4 (16.7%)	3 (12.5%)	6 (14.6%)	0.43
T1	17 (70.8%)	14 (58.3%)	31 (64.6%)
T2	3 (12.5%)	5 (20.8%)	8 (16.7%)
T3	0 (0.0%)	2 (8.3%)	2 (4.2%)
Pathological T-categories
T0-1	21 (87.5%)	17 (70.8%)	38 (79.2%)	0.29
T2-3	3 (12.5%)	7 (29.2%)	10 (20.8%)
Pathological N-categories
N0	10 (41.7%)	7 (29.2%)	17 (35.4%)	0.74
N1	9 (37.5%)	9 (37.5%)	18 (37.5%)
N2	4 (16.7%)	6 (25.0%)	10 (20.8%)
N3	1 (4.2%)	2 (8.3%)	3 (6.3%)
Pathological node
Negative	10 (41.7%)	7 (29.2%)	17 (35.4%)	0.55
Positive	14 (58.3%)	17 (70.8%)	31 (64.6%)
Pathological stage
0-I	10 (41.6%)	8 (33.3%)	15 (31.3%)	0.75
II-III	14 (58.4%)	16 (66.7%)	33 (68.8%)
Pathological stage
0	2 (8.3%)	0 (0.0%)	2 (4.2%)	0.50
I	8 (33.3%)	8 (33.3%)	16 (33.3%)
II	8 (33.3%)	7 (29.2%)	15 (31.3%)
III	6 (25.0%)	9 (37.5%)	15 (31.3%)

Table 2. The Main Different Parameters Between the Two Groups

Parameters

Control, n = 24

Experimental, n = 24

Total

P value

BCS: breast conservative surgery; RCB: residual cancer burden.

RCB

2 (8.3%)

0 (0.0%)

2 (4.2%)

0.22

4 (16.7%)

5 (20.8%)

9 (18.8%)

12 (50.0%)

8 (33.3%)

20 (41.7%)

III

6 (25.0%)

11 (45.8%)

17 (35.4%)

RCB

0-I

6 (25.0%)

5 (20.8%)

11 (22.9%)

0.73

II-III

18 (75.0%)

19 (79.2%)

37 (77.1%)

Type of surgery

BCS

14 (58.3%)

28 (58.3%)

1.0

MRM

10 (41.7%)

20 (41.7%)

Pathological-T

4 (16.7%)

3 (12.5%)

6 (14.6%)

0.43

17 (70.8%)

14 (58.3%)

31 (64.6%)

3 (12.5%)

5 (20.8%)

8 (16.7%)

0 (0.0%)

2 (8.3%)

2 (4.2%)

Pathological T-categories

T0-1

21 (87.5%)

17 (70.8%)

38 (79.2%)

0.29

T2-3

3 (12.5%)

7 (29.2%)

10 (20.8%)

Pathological N-categories

10 (41.7%)

7 (29.2%)

17 (35.4%)

0.74

9 (37.5%)

18 (37.5%)

4 (16.7%)

6 (25.0%)

10 (20.8%)

1 (4.2%)

2 (8.3%)

3 (6.3%)

Pathological node

Negative

10 (41.7%)

7 (29.2%)

17 (35.4%)

0.55

Positive

14 (58.3%)

17 (70.8%)

31 (64.6%)

Pathological stage

0-I

10 (41.6%)

8 (33.3%)

15 (31.3%)

0.75

II-III

14 (58.4%)

16 (66.7%)

33 (68.8%)

Pathological stage

2 (8.3%)

0 (0.0%)

2 (4.2%)

0.50

8 (33.3%)

16 (33.3%)

8 (33.3%)

7 (29.2%)

15 (31.3%)

III

6 (25.0%)

9 (37.5%)

15 (31.3%)

**Table 3.** Subgroup Analysis for RCB
Parameters	Control, n = 26	Experimental, n = 24	P value
RCB: residual cancer burden; PR: progesterone receptor.
Age
≤ 40 years	6 (23%)	6 (23%)	0	8 (33%)	0.072
> 40 years	3 (11%)	12 (46%)	5 (20%)	11 (50%)	0.47
Allred score
4 - 6	1 (3.8%)	5 (19%)	0	4 (16%)	0.39
> 6	5 (19%)	13 (50%)	5 (20%)	15 (62%)	0.84
PR status
Negative	0	3 (11%)	2 (8%)	3 (12%)	0.21
Positive	6 (23%)	15 (57%)	3 (12%)	16 (66%)	0.33
Ki67
≤ 20	2 (7%)	4 (15%)	0	5 (20%)	0.15
> 20	3 (11%)	9 (34%)	5 (20%)	11 (50%)	0.72
Clinical T-categories
T1-3	4 (15%)	8 (30%)	4 (16%)	11 (50%)	0.71
T4	2 (7%)	10 (38%)	1 (4%)	8 (33%)	0.72
Clinical N-categories
Negative	0	3 (11%)	0	3 (12%)	-
Positive	6 (23%)	15 (57%)	5 (20%)	16 (66%)	0.73
Clinical stage
II	5 (19%)	5 (19%)	4 (16%)	8 (33%)	0.43
III	1 (3.8%)	13 (50%)	1 (4%)	11 (50%)	0.91

Table 3. Subgroup Analysis for RCB

Parameters

Control, n = 26

Experimental, n = 24

P value

RCB 0-1

RCB

RCB 0-1

RCB

RCB: residual cancer burden; PR: progesterone receptor.

Age

≤ 40 years

6 (23%)

8 (33%)

0.072

> 40 years

3 (11%)

12 (46%)

5 (20%)

11 (50%)

0.47

Allred score

4 - 6

1 (3.8%)

5 (19%)

4 (16%)

0.39

> 6

5 (19%)

13 (50%)

5 (20%)

15 (62%)

0.84

PR status

Negative

3 (11%)

2 (8%)

3 (12%)

0.21

Positive

6 (23%)

15 (57%)

3 (12%)

16 (66%)

0.33

Ki67

≤ 20

2 (7%)

4 (15%)

5 (20%)

0.15

> 20

3 (11%)

9 (34%)

5 (20%)

11 (50%)

0.72

Clinical T-categories

T1-3

4 (15%)

8 (30%)

4 (16%)

11 (50%)

0.71

2 (7%)

10 (38%)

1 (4%)

8 (33%)

0.72

Clinical N-categories

Negative

3 (11%)

3 (12%)

Positive

6 (23%)

15 (57%)

5 (20%)

16 (66%)

0.73

Clinical stage

5 (19%)

4 (16%)

8 (33%)

0.43

III

1 (3.8%)

13 (50%)

1 (4%)

11 (50%)

0.91

**Table 4.** The Adverse Events Profiles Between the Two Groups
Adverse events type	Control	Denosumab
Vomiting	5 (20%)	4 (16%)	1 (4%)	7 (28%)	3	4 (16%)
Nausea	10 (40%)	10 (40%)	0	7 (28%)	7 (28%)	0
Hypocalcemia	1 (4%)	1 (4%)	0	4 (16%)	4 (16%)	0
Constipation	4 (16%)	4 (16%)	0	4 (16%)	4 (16%)	0
Fatigue	12 (48%)	8 (32%)	4 (16%)	11 (44%)	10 (40%)	1 (4%)
Stomatitis	9 (36%)	7 (28%)	2 (8%)	10 (40%)	9 (36%)	1 (4%)
Skin inflammation	4 (16%)	4 (16%)	0	5 (20%)	4 (16%)	1 (4%)
Neuropathy	6 (24%)	6 (24%)	0	4 (16%)	4 (16%)	0

Table 4. The Adverse Events Profiles Between the Two Groups

Adverse events type

Control

Denosumab

Incidence

Grade 1/2

Grade 3/4

Incidence

Grade 1/2

Grade 3/4

Vomiting

5 (20%)

4 (16%)

1 (4%)

7 (28%)

4 (16%)

Nausea

10 (40%)

7 (28%)

Hypocalcemia

1 (4%)

4 (16%)

Constipation

4 (16%)

Fatigue

12 (48%)

8 (32%)

4 (16%)

11 (44%)

10 (40%)

1 (4%)

Stomatitis

9 (36%)

7 (28%)

2 (8%)

10 (40%)

9 (36%)

1 (4%)

Skin inflammation

4 (16%)

5 (20%)

4 (16%)

1 (4%)

Neuropathy

6 (24%)

4 (16%)