Trial Outcomes & Findings for Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings. (NCT NCT05155566)
NCT ID: NCT05155566
Last Updated: 2024-01-26
Results Overview
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. Disease progression (PD): greater than equal to (\>=) 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 millimeter (mm) or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Recruitment status
COMPLETED
Target enrollment
847 participants
Primary outcome timeframe
Month 6 (from the data collected and observed retrospectively for approximately 22 months)
Results posted on
2024-01-26
Participant Flow
Participants with hormone receptor (HR) positive/Human Epidermal Growth Factor Receptor 2 (HER2) negative advanced or metastatic breast cancer who received palbociclib in combination with aromatase inhibitor or fulvestrant as first-line therapy were observed. Data was collected retrospectively from participants medical records and evaluated over approximately 22 months of this study.
Participant milestones
| Measure |
Palbociclib + Aromatase Inhibitor
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Overall Study
STARTED
|
574
|
273
|
|
Overall Study
COMPLETED
|
574
|
273
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Here, number anaylzed signifies participants evaluable for this baseline measure.
Baseline characteristics by cohort
| Measure |
Palbociclib + Aromatase Inhibitor
n=574 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=273 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
Total
n=847 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 Years
STANDARD_DEVIATION 11.4 • n=574 Participants
|
58.3 Years
STANDARD_DEVIATION 10.2 • n=273 Participants
|
60.0 Years
STANDARD_DEVIATION 11.1 • n=847 Participants
|
|
Sex: Female, Male
Female
|
574 Participants
n=574 Participants
|
273 Participants
n=273 Participants
|
847 Participants
n=847 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=574 Participants
|
0 Participants
n=273 Participants
|
0 Participants
n=847 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=574 Participants
|
0 Participants
n=273 Participants
|
1 Participants
n=847 Participants
|
|
Race/Ethnicity, Customized
Native American
|
5 Participants
n=574 Participants
|
3 Participants
n=273 Participants
|
8 Participants
n=847 Participants
|
|
Race/Ethnicity, Customized
Asian-Indian subcontinent
|
1 Participants
n=574 Participants
|
0 Participants
n=273 Participants
|
1 Participants
n=847 Participants
|
|
Race/Ethnicity, Customized
Asian - other
|
0 Participants
n=574 Participants
|
1 Participants
n=273 Participants
|
1 Participants
n=847 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
0 Participants
n=574 Participants
|
1 Participants
n=273 Participants
|
1 Participants
n=847 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
348 Participants
n=574 Participants
|
180 Participants
n=273 Participants
|
528 Participants
n=847 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
1 Participants
n=574 Participants
|
0 Participants
n=273 Participants
|
1 Participants
n=847 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
31 Participants
n=574 Participants
|
9 Participants
n=273 Participants
|
40 Participants
n=847 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
175 Participants
n=574 Participants
|
61 Participants
n=273 Participants
|
236 Participants
n=847 Participants
|
|
Race/Ethnicity, Customized
Afro-Caribbean
|
3 Participants
n=574 Participants
|
6 Participants
n=273 Participants
|
9 Participants
n=847 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=574 Participants
|
4 Participants
n=273 Participants
|
11 Participants
n=847 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=574 Participants
|
3 Participants
n=273 Participants
|
3 Participants
n=847 Participants
|
|
Race/Ethnicity, Customized
Prefer not to answer
|
2 Participants
n=574 Participants
|
5 Participants
n=273 Participants
|
7 Participants
n=847 Participants
|
|
Number of Participants According to Menopause Status at Palbociclib Initiation
Menopause Induced by LHRH Suppression
|
33 Participants
n=574 Participants
|
15 Participants
n=273 Participants
|
48 Participants
n=847 Participants
|
|
Number of Participants According to Menopause Status at Palbociclib Initiation
Menopause Induced by Surgery
|
49 Participants
n=574 Participants
|
10 Participants
n=273 Participants
|
59 Participants
n=847 Participants
|
|
Number of Participants According to Menopause Status at Palbociclib Initiation
Natural Menopause
|
483 Participants
n=574 Participants
|
234 Participants
n=273 Participants
|
717 Participants
n=847 Participants
|
|
Number of Participants According to Menopause Status at Palbociclib Initiation
Perimenopausal
|
2 Participants
n=574 Participants
|
12 Participants
n=273 Participants
|
14 Participants
n=847 Participants
|
|
Number of Participants According to Menopause Status at Palbociclib Initiation
Premenopausal
|
7 Participants
n=574 Participants
|
2 Participants
n=273 Participants
|
9 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Argentina-Servicio de Salud Publico
|
51 Participants
n=574 Participants
|
5 Participants
n=273 Participants
|
56 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Argentina-Seguridad Social
|
176 Participants
n=574 Participants
|
58 Participants
n=273 Participants
|
234 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Argentina-PrivadoPrepagas
|
123 Participants
n=574 Participants
|
56 Participants
n=273 Participants
|
179 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Mexico-ISSSTE
|
7 Participants
n=574 Participants
|
0 Participants
n=273 Participants
|
7 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Mexico-Sedena
|
0 Participants
n=574 Participants
|
1 Participants
n=273 Participants
|
1 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Mexico- PEMEX
|
4 Participants
n=574 Participants
|
3 Participants
n=273 Participants
|
7 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Mexico-Aseguradora privada
|
53 Participants
n=574 Participants
|
6 Participants
n=273 Participants
|
59 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Mexico-IMSS
|
10 Participants
n=574 Participants
|
4 Participants
n=273 Participants
|
14 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Mexico-SSA
|
5 Participants
n=574 Participants
|
0 Participants
n=273 Participants
|
5 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Mexico-Aseguradoras privadas
|
24 Participants
n=574 Participants
|
6 Participants
n=273 Participants
|
30 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Chile-FONASA (El Fondo Nacional de Salud)
|
1 Participants
n=574 Participants
|
5 Participants
n=273 Participants
|
6 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Chile-ISAPRE (Instituciones de Salud Previsional)
|
2 Participants
n=574 Participants
|
0 Participants
n=273 Participants
|
2 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Costa rica/Panama-CSS (Caja de seguridad social)
|
28 Participants
n=574 Participants
|
8 Participants
n=273 Participants
|
36 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Costa rica/Panama-Aseguradora privada
|
5 Participants
n=574 Participants
|
0 Participants
n=273 Participants
|
5 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Colombia-Contributive regime (POS-C)
|
57 Participants
n=574 Participants
|
82 Participants
n=273 Participants
|
139 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Colombia-Subsidized regime (POS-S)
|
22 Participants
n=574 Participants
|
16 Participants
n=273 Participants
|
38 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Colombia-Special regime (i.e. teacher or military)
|
1 Participants
n=574 Participants
|
22 Participants
n=273 Participants
|
23 Participants
n=847 Participants
|
|
Number of Participants According to Type of Insurance Plan
Colombia-Unknown
|
5 Participants
n=574 Participants
|
1 Participants
n=273 Participants
|
6 Participants
n=847 Participants
|
|
Number of Participants With Positive Biomarker Status
BRCA1
|
11 Participants
n=574 Participants
|
59 Participants
n=273 Participants
|
70 Participants
n=847 Participants
|
|
Number of Participants With Positive Biomarker Status
BRCA2
|
5 Participants
n=574 Participants
|
58 Participants
n=273 Participants
|
63 Participants
n=847 Participants
|
|
Number of Participants With Positive Biomarker Status
Androgen receptor
|
31 Participants
n=574 Participants
|
71 Participants
n=273 Participants
|
102 Participants
n=847 Participants
|
|
Number of Participants With Positive Biomarker Status
ESR1 mutation
|
0 Participants
n=574 Participants
|
36 Participants
n=273 Participants
|
36 Participants
n=847 Participants
|
|
Number of Participants According to Family History of Breast Cancer
Yes
|
115 Participants
n=574 Participants
|
57 Participants
n=273 Participants
|
172 Participants
n=847 Participants
|
|
Number of Participants According to Family History of Breast Cancer
No
|
421 Participants
n=574 Participants
|
193 Participants
n=273 Participants
|
614 Participants
n=847 Participants
|
|
Number of Participants According to Family History of Breast Cancer
Unknown
|
38 Participants
n=574 Participants
|
23 Participants
n=273 Participants
|
61 Participants
n=847 Participants
|
|
Number of Participants According to Stage of Initial Breast Cancer
Stage 0
|
0 Participants
n=574 Participants
|
1 Participants
n=273 Participants
|
1 Participants
n=847 Participants
|
|
Number of Participants According to Stage of Initial Breast Cancer
Stage 1
|
21 Participants
n=574 Participants
|
11 Participants
n=273 Participants
|
32 Participants
n=847 Participants
|
|
Number of Participants According to Stage of Initial Breast Cancer
Stage 2
|
111 Participants
n=574 Participants
|
91 Participants
n=273 Participants
|
202 Participants
n=847 Participants
|
|
Number of Participants According to Stage of Initial Breast Cancer
Stage 3a
|
86 Participants
n=574 Participants
|
144 Participants
n=273 Participants
|
230 Participants
n=847 Participants
|
|
Number of Participants According to Stage of Initial Breast Cancer
Stage 3b
|
41 Participants
n=574 Participants
|
5 Participants
n=273 Participants
|
46 Participants
n=847 Participants
|
|
Number of Participants According to Stage of Initial Breast Cancer
Stage 3c
|
21 Participants
n=574 Participants
|
1 Participants
n=273 Participants
|
22 Participants
n=847 Participants
|
|
Number of Participants According to Stage of Initial Breast Cancer
Stage 4
|
294 Participants
n=574 Participants
|
20 Participants
n=273 Participants
|
314 Participants
n=847 Participants
|
|
Number of Participants With Metastases to Lymph Nodes
Lymph nodes, Regional
|
85 Participants
n=485 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
12 Participants
n=203 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
97 Participants
n=688 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Metastases to Lymph Nodes
Lymph nodes, Distal
|
59 Participants
n=485 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
31 Participants
n=203 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
90 Participants
n=688 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0
|
154 Participants
n=574 Participants
|
59 Participants
n=273 Participants
|
213 Participants
n=847 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1
|
307 Participants
n=574 Participants
|
110 Participants
n=273 Participants
|
417 Participants
n=847 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 2
|
103 Participants
n=574 Participants
|
43 Participants
n=273 Participants
|
146 Participants
n=847 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 3
|
6 Participants
n=574 Participants
|
32 Participants
n=273 Participants
|
38 Participants
n=847 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 4
|
3 Participants
n=574 Participants
|
28 Participants
n=273 Participants
|
31 Participants
n=847 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status
Unknown
|
1 Participants
n=574 Participants
|
1 Participants
n=273 Participants
|
2 Participants
n=847 Participants
|
|
Number of Participants According to Diagnosis for Which Palbociclib Combination was Prescribed
|
574 Participants
n=574 Participants
|
273 Participants
n=273 Participants
|
847 Participants
n=847 Participants
|
|
Number of Participants According to Different Sites of Metastases
Bone
|
374 Participants
n=485 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
140 Participants
n=203 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
514 Participants
n=688 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants According to Different Sites of Metastases
Lymph node
|
145 Participants
n=485 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
43 Participants
n=203 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
188 Participants
n=688 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants According to Different Sites of Metastases
Lung
|
156 Participants
n=485 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
54 Participants
n=203 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
210 Participants
n=688 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants According to Different Sites of Metastases
Liver
|
89 Participants
n=485 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
32 Participants
n=203 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
121 Participants
n=688 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants According to Different Sites of Metastases
Brain
|
8 Participants
n=485 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
2 Participants
n=203 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
10 Participants
n=688 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants According to Different Sites of Metastases
Skin/soft tissue
|
87 Participants
n=485 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
40 Participants
n=203 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
127 Participants
n=688 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants According to Different Sites of Metastases
Ovary
|
3 Participants
n=485 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
6 Participants
n=203 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
9 Participants
n=688 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants According to Different Sites of Metastases
Other
|
4 Participants
n=485 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
3 Participants
n=203 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
7 Participants
n=688 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants According to Different Sites of Metastases
Visceral disease
|
221 Participants
n=485 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
84 Participants
n=203 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
305 Participants
n=688 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants According to Different Sites of Metastases
Non-visceral disease
|
264 Participants
n=485 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
119 Participants
n=203 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
383 Participants
n=688 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With De novo and Recurrent Breast Cancer
De Novo
|
356 Participants
n=574 Participants
|
26 Participants
n=273 Participants
|
382 Participants
n=847 Participants
|
|
Number of Participants With De novo and Recurrent Breast Cancer
Recurrent
|
218 Participants
n=574 Participants
|
247 Participants
n=273 Participants
|
465 Participants
n=847 Participants
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Bradyarrhythmias
|
1 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
2 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
3 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Cerebrovascular disease
|
7 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
3 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
10 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Congestive heart failure
|
5 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
8 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
13 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Chronic pulmonary disease
|
12 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
11 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
23 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Connective tissue disease
|
1 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
0 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
1 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Dementia
|
5 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
2 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
7 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Diabetes with end organ damage
|
12 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
1 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
13 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Diabetes without end organ damage
|
89 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
46 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
135 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Depression
|
50 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
35 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
85 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Electrolyte abnormalities
|
2 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
0 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
2 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Hypertension
|
227 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
94 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
321 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Long QT syndrome
|
1 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
0 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
1 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Mild liver disease
|
7 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
8 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
15 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Moderate to severe renal disease
|
5 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
23 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
28 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Myelosuppression
|
2 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
0 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
2 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Myocardial infarction
|
1 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
1 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
2 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Peptic ulcer disease
|
18 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
9 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
27 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Peripheral vascular disease
|
14 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
3 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
17 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Unstable angina
|
2 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
2 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
4 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Unknown
|
9 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
4 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
13 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
Other
|
21 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
9 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
30 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Comorbidities Diagnosed in 12 Months Prior to Palbociclib Initiation
None
|
257 Participants
n=574 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
106 Participants
n=273 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
363 Participants
n=847 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants Prescribed Palbociclib (Aromatase Inhibitor or Fulvestrant at First Line)
|
574 Participants
n=574 Participants
|
273 Participants
n=273 Participants
|
847 Participants
n=847 Participants
|
|
Age at Initial Breast Cancer Diagnosis
|
58.1 Years
STANDARD_DEVIATION 12.0 • n=541 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
55.2 Years
STANDARD_DEVIATION 10.0 • n=255 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
57.2 Years
STANDARD_DEVIATION 11.5 • n=796 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Age at Advanced Breast Cancer (ABC)/Metastatic Breast Cancer (mBC) Diagnosis
|
60.4 Years
STANDARD_DEVIATION 11.7 • n=539 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
58.3 Years
STANDARD_DEVIATION 10.0 • n=258 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
59.7 Years
STANDARD_DEVIATION 11.2 • n=797 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Time From Initial Breast Cancer Diagnosis to ABC/mBC Diagnosis
|
58.0 Months
n=207 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
25.1 Months
n=227 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
39.2 Months
n=434 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Time from ABC/mBC Diagnosis to Palbociclib Initiation
|
1.8 Months
n=539 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
1.4 Months
n=258 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
1.7 Months
n=797 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Number of Participants With Adjuvant Treatments Received Since Breast Cancer Diagnosis
Adjuvant Chemotherapy
|
130 Participants
n=574 Participants
|
138 Participants
n=273 Participants
|
268 Participants
n=847 Participants
|
|
Number of Participants With Adjuvant Treatments Received Since Breast Cancer Diagnosis
Adjuvant endocrine therapy
|
178 Participants
n=574 Participants
|
245 Participants
n=273 Participants
|
423 Participants
n=847 Participants
|
|
Number of Participants who Received Radiotherapy or Surgery
Radiotherapy
|
177 Participants
n=574 Participants
|
200 Participants
n=273 Participants
|
377 Participants
n=847 Participants
|
|
Number of Participants who Received Radiotherapy or Surgery
Surgery
|
190 Participants
n=574 Participants
|
195 Participants
n=273 Participants
|
385 Participants
n=847 Participants
|
|
Duration of adjuvant endocrine therapy
|
40.7 Months
STANDARD_DEVIATION 25.4 • n=178 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
24.3 Months
STANDARD_DEVIATION 22.4 • n=245 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
31.2 Months
STANDARD_DEVIATION 25.0 • n=423 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Time From Initial Breast Cancer Diagnosis to Palbociclib Initiation
|
6.0 Months
n=541 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
27.0 Months
n=255 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
15.3 Months
n=796 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
|
Time From Advanced/Metastatic Diagnosis to Palbociclib Initiation
|
1.8 Months
n=539 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
1.4 Months
n=258 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
1.7 Months
n=797 Participants • Here, number anaylzed signifies participants evaluable for this baseline measure.
|
PRIMARY outcome
Timeframe: Month 6 (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. Disease progression (PD): greater than equal to (\>=) 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 millimeter (mm) or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=573 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=273 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Progression Free Rate at Month 6
|
93.4 Percentage of participants
|
91.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 12 (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=573 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=273 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Progression Free Rate at Month 12
|
80.9 Percentage of participants
|
76.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 18 (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=573 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=273 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Progression Free Rate at Month 18
|
68.8 Percentage of participants
|
66.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 24 (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Progression free rate was defined as percentage of participants who were progression free at defined time point. Progression free was defined as the time from palbociclib combination treatment initiation until the earliest of 1) clinician-documented disease progression while on palbociclib; 2) death; 3) start of a new therapy line after final palbociclib dose if the reason for discontinuation of palbociclib was disease progression; 4) last available follow-up. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Participants who did not experience a progression event (items 1, 2, 3) were censored at date of last available follow-up. Progression free rate was estimated by Kaplan-Meier analysis.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=573 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=273 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Progression Free Rate at Month 24
|
60.9 Percentage of participants
|
56.1 Percentage of participants
|
PRIMARY outcome
Timeframe: From date of palbociclib combination treatment initiation to date of CR or PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Objective response rate was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=572 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=272 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Objective Response Rate
|
69.8 Percentage of participants
|
67.3 Percentage of participants
|
PRIMARY outcome
Timeframe: 1 year post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Percentage of participants who were alive after 1 year post palbociclib combination treatment initiation were based on the Kaplan-Meier estimate.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=557 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=265 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Percentage of Participants Alive After 1 Year Post Palbociclib Combination Treatment Initiation
|
95.0 Percentage of participants
|
96.9 Percentage of participants
|
PRIMARY outcome
Timeframe: 2 years post palbociclib combination treatment initiation (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Percentage of participants who were alive after 2 years post palbociclib treatment initiation were based on the Kaplan-Meier estimate.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=557 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=265 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Percentage of Participants Alive After 2 Years Post Palbociclib Combination Treatment Initiation
|
83.0 Percentage of participants
|
88.8 Percentage of participants
|
PRIMARY outcome
Timeframe: From date of palbociclib combination treatment initiation to date of PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Clinical benefit rate was defined as the percentage of participants achieving CR, PR or stable disease (SD) \>=24 weeks on palbociclib combination therapy. CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Participants with 12-24 weeks follow up data who remained on palbociclib for the duration of their follow up without evidence of CR or PR or PD were censored.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=572 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=272 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Clinical Benefit Rate
|
94.2 Percentage of participants
|
95.2 Percentage of participants
|
PRIMARY outcome
Timeframe: From date of palbociclib combination treatment initiation to date of SD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=572 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=272 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Percentage of Participants With Stable Disease >=24 Weeks on Palbociclib
|
24.5 Percentage of participants
|
23.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 6 (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=557 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=265 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Survival Rate at Month 6
|
98.9 Percentage of participants
|
99.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 12 (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=557 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=265 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Survival Rate at Month 12
|
95.0 Percentage of participants
|
96.9 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 18 (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=557 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=265 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Survival Rate at Month 18
|
87.7 Percentage of participants
|
91.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 24 (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Survival rate was defined as percentage of participants who were not deceased at defined time points. Survival was defined as time from the date of initiation of palbociclib combination therapy to the date of death due to any cause or end of follow-up (if earlier). Survival rate was estimated by Kaplan-Meier analysis.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=557 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=265 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Survival Rate at Month 24
|
83.0 Percentage of participants
|
88.8 Percentage of participants
|
PRIMARY outcome
Timeframe: From date of palbociclib initiation to date of first documented CR, PR, SD or PD, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
CR was defined as complete resolution of all visible disease per the treating physicians opinion. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. SD was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=505 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=237 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Time From Palbociclib Initiation to Initial Response Recorded
|
3.2 Months
Interval 0.1 to 27.6
|
3.0 Months
Interval 0.0 to 15.8
|
PRIMARY outcome
Timeframe: From date of palbociclib initiation to date of first documented CR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
CR was defined as complete resolution of all visible disease per the treating physicians opinion.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=51 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=72 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Time From Palbociclib Initiation to Complete Response
|
4.5 Months
Interval 1.0 to 27.6
|
4.0 Months
Interval 0.5 to 16.3
|
PRIMARY outcome
Timeframe: From date of palbociclib initiation to date of first documented PR, up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=315 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=95 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Time From Palbociclib Initiation to Partial Response
|
3.2 Months
Interval 0.1 to 19.4
|
3.2 Months
Interval 0.0 to 10.3
|
PRIMARY outcome
Timeframe: From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=574 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=273 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Follow-up Time Since Palbociclib Initiation
|
12.7 Months
Interval 6.0 to 37.4
|
10.7 Months
Interval 3.0 to 36.0
|
PRIMARY outcome
Timeframe: From date of palbociclib combination treatment initiation until end of follow-up, maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Participants could receive more than one supportive treatment.
Number of participants who received supportive therapies during palbociclib treatment were reported.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=574 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=273 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Number of Participants With Supportive Therapies
Unknown
|
2 Participants
|
2 Participants
|
|
Number of Participants With Supportive Therapies
Bisphosphonates
|
246 Participants
|
88 Participants
|
|
Number of Participants With Supportive Therapies
Non-steroidal anti-inflammatory drugs
|
232 Participants
|
88 Participants
|
|
Number of Participants With Supportive Therapies
Opioid extended release
|
100 Participants
|
79 Participants
|
|
Number of Participants With Supportive Therapies
Anti-emetics
|
53 Participants
|
19 Participants
|
|
Number of Participants With Supportive Therapies
Anti-anxiety drugs
|
85 Participants
|
34 Participants
|
|
Number of Participants With Supportive Therapies
Anti-depressants
|
43 Participants
|
56 Participants
|
|
Number of Participants With Supportive Therapies
Opioid immediate release
|
47 Participants
|
20 Participants
|
|
Number of Participants With Supportive Therapies
Other supportive care
|
35 Participants
|
56 Participants
|
|
Number of Participants With Supportive Therapies
Antibiotics
|
51 Participants
|
19 Participants
|
|
Number of Participants With Supportive Therapies
Nutritional support
|
46 Participants
|
68 Participants
|
|
Number of Participants With Supportive Therapies
Granulocyte colony stimulating factors
|
24 Participants
|
7 Participants
|
|
Number of Participants With Supportive Therapies
Antifungals
|
9 Participants
|
2 Participants
|
|
Number of Participants With Supportive Therapies
Red blood cell transfusion
|
37 Participants
|
11 Participants
|
|
Number of Participants With Supportive Therapies
Pruritus/rash treatments
|
5 Participants
|
1 Participants
|
|
Number of Participants With Supportive Therapies
Erythropoietin stimulating agents
|
3 Participants
|
2 Participants
|
|
Number of Participants With Supportive Therapies
Platelet transfusions
|
7 Participants
|
4 Participants
|
|
Number of Participants With Supportive Therapies
Antivirals
|
1 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=391 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=142 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Duration of Ongoing Palbociclib Treatment
|
11.2 Months
Interval 6.0 to 37.4
|
8.5 Months
Interval 3.0 to 31.5
|
PRIMARY outcome
Timeframe: Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=183 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=131 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Duration of Discontinued Palbociclib Treatment
|
8.0 Months
Interval 0.3 to 27.5
|
5.0 Months
Interval 1.0 to 25.1
|
PRIMARY outcome
Timeframe: Up to maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted.
Number of participants who received therapies post palbociclib treatment were reported.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=574 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=273 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Toremifene / FARESTON
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Palbociclib / IBRANCE and Fulvestrant/FASLODEX
|
0 Participants
|
34 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Palbociclib/IBRANCE andFulvestrant/FASLODEX,Exemestane/AROMASIN,Methotrexate
|
0 Participants
|
2 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Palbociclib/IBRANCE andFulvestrant/ FASLODEX,Letrozole/FEMARA
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Palbociclib/IBRANCE andFulvestrant/FASLODEX,Methotrexate
|
0 Participants
|
7 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Palbociclib/IBRANCE andFulvestrant/ FASLODEX,Tamoxifen/NOLVADEX,Methotrexate
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Palbociclib/IBRANCE andLetrozole/ FEMARA
|
4 Participants
|
0 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Anastrozole/ARIMIDEX
|
2 Participants
|
1 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Capecitabine/XELODA
|
15 Participants
|
15 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Docetaxel/TAXOTERE
|
6 Participants
|
1 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Docetaxel/TAXOTERE,Capecitabine / XELODA
|
3 Participants
|
1 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Doxorubicin/ADRIAMYCIN
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Doxorubicin/ADRIAMYCIN,Cyclophosphamide/CYTOXAN
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Everolimus/AFINITOR andExemestane/AROMASIN
|
11 Participants
|
7 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Exemestane/AROMASIN
|
6 Participants
|
3 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Fulvestrant/FASLODEX
|
16 Participants
|
1 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Gemcitabine/GEMZAR
|
4 Participants
|
0 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Nab Paclitaxel/ABRAXANE
|
1 Participants
|
2 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Other
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Paclitaxel/TAXOL
|
13 Participants
|
4 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Paclitaxel/TAXOL,Capecitabine / XELODA
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Paclitaxel/TAXOL,Doxorubicin/ ADRIAMYCIN,Cyclophosphamide/CYTOXAN
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Paclitaxel/TAXOL,Gemcitabine/ GEMZAR
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Palbociclib/IBRANCE and Anastrozole /ARIMIDEX,Methotrexate
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Palbociclib/ IBRANCE and Exemestane / AROMASIN,Capecitabine/XELODA
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Palbociclib / IBRANCE and Fulvestrant/FASLODEX,Ixabepilone /IXEMPRA
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Ribociclib / KISQALI and Exemestane / AROMASIN,Epirubicin /PHARMORUBICIN
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Tamoxifen / NOLVADEX
|
3 Participants
|
1 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
Tamoxifen / NOLVADEX,Doxorubicin / ADRIAMYCIN
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Therapies Received Post Palbociclib Treatment
No treatment
|
482 Participants
|
188 Participants
|
PRIMARY outcome
Timeframe: Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=103 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=24 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Time From Palbociclib Initiation to First Dose Reduction
|
3.7 Months
Interval 0.7 to 21.8
|
3.4 Months
Interval 0.6 to 13.3
|
PRIMARY outcome
Timeframe: Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=12 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=1 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Duration of Dose Interruption
|
14.0 Days
Interval 7.0 to 106.0
|
21.0 Days
Interval 21.0 to 21.0
|
PRIMARY outcome
Timeframe: Up to a maximum of 37.4 months (from the data collected and observed retrospectively for approximately 22 months)Population: FAS comprised of participants for whom a complete medical record review was conducted. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Palbociclib + Aromatase Inhibitor
n=2 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with aromatase inhibitor were observed during this retrospective study.
|
Palbociclib + Fulvestrant
n=4 Participants
Participants with HR positive/HER2 negative advanced or metastatic breast cancer who received palbociclib as a first-line therapy along with fulvestrant were observed during this retrospective study.
|
|---|---|---|
|
Duration of Cycle Delays
|
24.5 Days
Interval 14.0 to 35.0
|
21.0 Days
Interval 7.0 to 31.0
|
Adverse Events
Palbociclib + Aromatase Inhibitor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 54 deaths
Palbociclib + Fulvestrant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 15 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER