Efficacy and tolerability of BP-C1 in metastatic breast cancer: a Phase II, randomized, double-blind, and placebo-controlled Thai multi-center study

Figures & data

Table 1 Baseline characteristics and previous cancer treatments

Factor specifications		Controlled clinical study
		BP-C1 (N=16)	Placebo (N=15)
Demographic factors and vital signs	Age (years)	52.1 (7.2) 35.6–64.2	56.4 (10.1) 35.6–74.3
	Duration of disease (years)	4.9 (3.2) 1.5–11.2	4.03 (2.2) 1.4–8.8
	BMI (kg/m^2)	23.0 (3.0) 17.1–29.3	21.9 (4.8) 13.3–30.9
	Systolic blood pressure (mmHg)	117 (16) 92–140	121 (14) 95–151
	Diastolic blood pressure (mmHg)	76 (9) 64–93	75 (12) 54–94
	Heart rate (beats/min)	91 (12) 76–112	88 (13) 62–112
	Respiratory rate (breath/min)	19.9 (1.1) 18.0–22.0	20.5 (0.9) 20.0–22.0
Previous cancer treatment	Surgery	14	14
	Hormone therapy	8	8
	Antibody therapy	0	0
	Radiotherapy	13	13
	Others	0	0

Notes: Assumed continuously distributed factors are expressed by mean value, StD in brackets, and total range. The discrete factors are expressed in the number of patients.

Abbreviation: BMI, body mass index; StD, standard deviation.

Figure 1 The development in sum of the largest diameters of target lesions in millimeter.

Notes: The results are expressed by mean values with 95% CIs illustrated by columns. The horizontal line crossing the columns shows the mean values. The green column shows BP-C1, and the yellow column shows placebo. The blue column shows the development in the 12 patients after switching from placebo to BP-C1.

Table 2 Treatment response after 32-day of treatment with BP-C1 and placebo

Treatment group	Day 32 of treatment		Total
	PD	SD
Randomized to BP-C1	3	13 (81.3% [54.3–96.0])	16
Randomized to placebo	10	5 (33.3% [11.8–61.6])	15
Placebo group crossed over to BP-C1	1	11 (91.7% [61.5–99.8])	12
Joint BP-C1 group	4	24 (85.7% [67.3–96.0])	28

Note: The results expressed as observed numbers with percent responder and 95% CI.

Abbreviations: PD, progressive disease; SD, stable disease.

Figure 2 The development in sum of CTC-NCI toxicity score from screening to Days 16 and 32 in the BP-C1 group and the placebo group.

Notes: The results are expressed by mean values with 95% CIs illustrated by columns. The horizontal line crossing the columns shows the mean values. The green column shows BP-C1, and the yellow column shows placebo.

Table 3 Comparison between groups and development within groups with regard to the sum of scores within each of the three parts in questionnaires QLQ-BR23CIs

Variables	Treatments	Screening	Day 16 of treatment	Day 32 of treatment	Increase (day 32-screening)
Breast cancer treatment problems last week	BP-C1 (N=16)	16.1 (3.6) 14.1–18.0	14.3 (4.6) 11.8–16.8	16.5 (3.2) 14.8–18.2	0.4 (2.8) −1.0 to 1.9
	Placebo (N=15)	15.3 (2.3) 14.0–16.5	15.3 (2.4) 13.9–16.6	15.3 (2.5) 14.0–16.7	0.1 (3.2) −1.7 to 1.8
Sexual interest and activity last 4 weeks	BP-C1 (N=16)	3.1 (1.8) 2.2–4.1	2.8 (1.8) 1.9–3.8	2.8 (1.6) 1.9–3.6	−0.4 (1.5) −1.2 to 0.4
	Placebo (N=15)	3.4 (2.1) 2.3–4.5	2.7 (1.6) 1.9–3.6	2.2 (0.6) 1.9–2.5	−1.2 (2.1) −2.4 to −0.1
Breast cancer-related pain and discomfort last week	BP-C1 (N=16)	11.1 (4.1) 8.9–13.3	10.0 (4.0) 7.4–12.6	11.3 (4.6) 8.9–13.7	0.2 (2.1) −0.9 to 1.3
	Placebo (N=15)	9.6 (1.9) 8.5–10.7	10.0 (3.0) 8.3–11.7	10.5 (4.1) 8.3–12.8	0.9 (2.9) −0.7 to 2.5

Note: The results expressed as mean values with 95% CIs and StD in brackets.

Abbreviation: StD, standard deviation.

Table 4 “Negative” and “positive” ER, PR, and HER2 comparison with regard the development in the sum of target diameter lesions

Receptors	Classification	Sum lesion diameter			P-value
		Baseline	Day 32	% (Day 32 to baseline)
ER	Negative (n=13)	56.5 (38.9) 32.9–80.0	54.9 (39.6) 31.0–78.9	−0.4 (20.9) −12.9 to 12.3	0.12
	Positive (n=15)	58.2 (54.7) 27.9–88,5	61.3 (54.3) 31.2–91.4	11.4 (18.3) 1.3–21.6
PtR	Negative (n=15)	66.3 (43.1) 42.4–90.1	65.6 (46.3) 39.9–91.3	−2.0 (16.2) −11.0 to 6.9	0.02
	Positive (n=13)	42.2 (51.3) 16.1–78.2	49.9 (48.9) 20.4–79.4	15.2 (20.7) 2.6–27.7
HER2	Negative (n=15)	60.8 (52.5) 31.7–89.9	62.4 (53.4) 32.5–91.7	4.3 (13.0) −2.9 to 11.4	0.64
	Positive (n=13)	53.5 (42.0) 28.1–78.8	53.9 (40.8) 29.2–78.6	7.9 (26.5) −8.1 to 24.0

Note: The results expressed by mean values, StD in brackets, and 95% CIs.

Abbreviations: ER, estrogen receptor; HER2, human EGF receptor 2; PtR, progesterone receptor; StD, standard deviation.

Table 5 Comparison of number of negative receptors with regard the development in the sum of target diameter lesionsCIs

Number of negative receptors	Sum lesion diameter			P-value
	Baseline	Day 32	% (Day 32 to baseline)
0 negative receptors (n=3)	34.3 (31.8) −44.7 to 113.4	40.7 (31.4) −37.3 to 118.6	29.3 (32.5) −51.5 to 110.2	0.03
1 negative receptor (n=12)	53.8 (53.9) 19.6 to 88.1	55.8 (52.3) 22.6 to 89.0	9.7 (14.7) 0.3 to 19.0
2 negative receptors (n=8)	72.5 (52.4) 28.7 to 116.3	70.4 (55.0) 24.4 to 116.3	−3.0 (20.3) −20.0 to 14.0
3 negative receptors (n=5)	55.6 (28.6) 20.0 to 91.2	55.6 (35.5) 11.5 to 99.7	−2.6 (13.0) −18.8 to 13.5
0 or 1 negative receptor (n=15)	49.0 (50.0) 22.3 to 77.6	52.8 (48.2) 26.1 to 79.5	13.6 (19.7) 2.7 to 24.5	0.03
2 or 3 negative receptors (n=13)	66.0 (44.1) 39.3 to 92.7	64.7 (47.3) 36.1 to 93.3	−2.8 (17.3) −13.3 to 7.6

Note: The results expressed by mean values, StD in brackets, and 95% CIs.

Abbreviation: StD, standard deviation.