Breast Cancer
Conditions
Brief summary
This observational study will evaluate the routine clinical use and the safety and efficacy of capecitabine (Xeloda®) in participants with metastatic or advanced breast cancer. Eligible participants will be followed for up to 24 months.
Interventions
DRUGCapecitabine
Oral tablet(s) administered according to prescribing information
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult female participants, \>/= 18 years of age * Cytologic/histopathologic confirmed diagnosis of metastatic breast cancer * Prescribed capecitabine as in routine clinical practice * Informed consent signed
Exclusion criteria
* Participation in any other clinical trial * History of severe and unexpected reactions to fluoropyrimidine therapy * Hypersensitivity to capecitabine or to any of the excipients of fluorouracil * Known dihydropyrimidine dehydrogenase (DPD) deficiency * Pregnant or lactating women * Severe leucopenia, neutropenia, or thrombocytopenia * Severe hepatic impairment * Severe renal impairment (creatinine clearance below 30 ml/min) * Treatment with sorivudine or its chemically related analogues, such as brivudine * Refusal to give consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy | Up to approximately 4 years | To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment. |
| Percentage of Participants Receiving Concomitant Medications During the Study | Up to approximately 4 years | Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Relevant Medical History Assessed at Baseline | Day 1 | To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized. |
| Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline | Day 1 | To document the metastatic breast cancer participant profile, the percentage of participants with histopathology grade diagnosis of moderately differentiated, well differentiated, poorly differentiated/undifferentiated as assessed at baseline was summarized. |
| Mean Survival Time | Up to approximately 4 years | — |
| Percentage of Participants With Adverse Events | Up to approximately 4 years | — |
Countries
Pakistan
Participant flow
Pre-assignment details
274 participants were enrolled in the study; of these, 23 participants from 3 centers were excluded from the analysis due to study termination at those 3 centers. The remaining 251 participants were eligible for analysis.
Participants by arm
| Arm | Count |
|---|---|
| Monotherapy Capecitabine as monotherapy according to prescribing information and normal clinical practice. | 188 |
| Combination Therapy Capecitabine as part of combination therapy according to prescribing information and normal clinical practice. | 63 |
| Total | 251 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 84 | 40 |
| Overall Study | Lost to Follow-up | 81 | 6 |
| Overall Study | Withdrawal by Subject | 10 | 0 |
Baseline characteristics
| Characteristic | Monotherapy | Combination Therapy | Total |
|---|---|---|---|
| Age, Continuous | 47.00 years STANDARD_DEVIATION 12.35 | 45.00 years STANDARD_DEVIATION 15.19 | 47.00 years STANDARD_DEVIATION 12.11 |
| Sex: Female, Male Female | 188 Participants | 63 Participants | 251 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 73 / 188 | 42 / 63 |
| serious Total, serious adverse events | 85 / 188 | 42 / 63 |
Outcome results
Primary
Percentage of Participants Receiving Concomitant Medications During the Study
Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported.
Time frame: Up to approximately 4 years
Population: Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Monotherapy | Percentage of Participants Receiving Concomitant Medications During the Study | 17.5 percentage of participants |
| Combination Therapy | Percentage of Participants Receiving Concomitant Medications During the Study | 23.8 percentage of participants |
Primary
Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy
To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment.
Time frame: Up to approximately 4 years
Population: Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Monotherapy | Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy | First Line | 10.6 percentage of participants |
| Monotherapy | Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy | Second Line | 71.8 percentage of participants |
| Monotherapy | Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy | Third Line | 17.6 percentage of participants |
| Combination Therapy | Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy | First Line | 55.6 percentage of participants |
| Combination Therapy | Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy | Second Line | 41.3 percentage of participants |
| Combination Therapy | Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy | Third Line | 3.1 percentage of participants |
Secondary
Mean Survival Time
Time frame: Up to approximately 4 years
Population: Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Monotherapy | Mean Survival Time | 15.493 Months |
| Combination Therapy | Mean Survival Time | 15.417 Months |
p-value: 0.895Log Rank (Mantel-Cox)
Secondary
Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline
To document the metastatic breast cancer participant profile, the percentage of participants with histopathology grade diagnosis of moderately differentiated, well differentiated, poorly differentiated/undifferentiated as assessed at baseline was summarized.
Time frame: Day 1
Population: Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Monotherapy | Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline | Moderately Differentiated | 42.6 percentage of participants |
| Monotherapy | Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline | Well Differentiated | 9.0 percentage of participants |
| Monotherapy | Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline | Poorly Differentiated/Undifferentiated | 48.4 percentage of participants |
| Combination Therapy | Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline | Moderately Differentiated | 42.9 percentage of participants |
| Combination Therapy | Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline | Well Differentiated | 11.1 percentage of participants |
| Combination Therapy | Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline | Poorly Differentiated/Undifferentiated | 46.0 percentage of participants |
Secondary
Percentage of Participants With Adverse Events
Time frame: Up to approximately 4 years
Population: Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Monotherapy | Percentage of Participants With Adverse Events | 45.2 percentage of participants |
| Combination Therapy | Percentage of Participants With Adverse Events | 66.7 percentage of participants |
Secondary
Percentage of Participants With Relevant Medical History Assessed at Baseline
To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized.
Time frame: Day 1
Population: Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Monotherapy | Percentage of Participants With Relevant Medical History Assessed at Baseline | Family History of Breast Cancer | 9.6 percentage of participants |
| Monotherapy | Percentage of Participants With Relevant Medical History Assessed at Baseline | Premenopausal Status | 54.8 percentage of participants |
| Monotherapy | Percentage of Participants With Relevant Medical History Assessed at Baseline | History of Co-morbidities | 18.1 percentage of participants |
| Monotherapy | Percentage of Participants With Relevant Medical History Assessed at Baseline | Postmenopausal Status | 45.2 percentage of participants |
| Monotherapy | Percentage of Participants With Relevant Medical History Assessed at Baseline | History of Other Types of Cancer | 0.5 percentage of participants |
| Combination Therapy | Percentage of Participants With Relevant Medical History Assessed at Baseline | Postmenopausal Status | 58.7 percentage of participants |
| Combination Therapy | Percentage of Participants With Relevant Medical History Assessed at Baseline | History of Other Types of Cancer | 1.6 percentage of participants |
| Combination Therapy | Percentage of Participants With Relevant Medical History Assessed at Baseline | Family History of Breast Cancer | 12.7 percentage of participants |
| Combination Therapy | Percentage of Participants With Relevant Medical History Assessed at Baseline | History of Co-morbidities | 28.6 percentage of participants |
| Combination Therapy | Percentage of Participants With Relevant Medical History Assessed at Baseline | Premenopausal Status | 41.3 percentage of participants |