Breast Cancer
Conditions
Brief summary
This multicenter, single-arm observational study will evaluate the clinical benefits of Avastin (bevacizumab) in combination with paclitaxel in first-line treatment in patients with metastatic breast cancer. Patients with metastatic breast cancer who have started Avastin treatment within 6 months prior to study start will also be eligible. Data will be collected from patients for up to 5 years.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with metastatic breast cancer initiated on first-line treatment with Avastin in combination with paclitaxel according to the current Hungarian summary of Product Characteristics * Patients with metastatic breast cancer initiated within 6 months before the start of the study on treatment with Avastin according to the current Hungarian Summary of Product Characteristics
Exclusion criteria
Contraindications for Avastin according to the current Hungarian Summary of Product Characteristics: * Hypersensitivity to active ingredient of Avastin or to any excipients * Hypersensitivity to products produced in Chinese hamster cells or to other recombinant or humanized antibodies * Pregnancy * Untreated central nervous system metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | Approximately 5 years | Progression free survival (PFS) was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Discontinuation (TTD) of Bevacizumab Treatment | Approximately 5 years | Time to treatment discontinuation is defined as the time to change of therapy due to any cause (tumour progression, toxicity, or other causes) from the start of bevacizumab treatment. |
| Participants With Hormone Receptor Status at Diagnosis | Baseline (Day 1) | The hormone receptor status for Oestrogen (ER), Progesterone (PgR) and Human epidermal growth factor receptor (HER-2) is reported as positive, negative, unknown or missing. |
| Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry | Approximately 5 years | PFS was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment for participants with triple negative status and not triple negative status. |
| Participants With Tumor Stage at Diagnosis | Baseline (Day 1) | Number of participants at each Metastatic breast cancer stage 0, I, II, III or IV, at the point of diagnosis is reported. |
| One Year Survival | Approximately 5 years | The status of participants whether alive, dead, unknown or missing one year after the start of bevacizumab treatment is reported. |
| Participants With Prior Therapy at Study Entry (Baseline) | Baseline (Day 1) | The status of prior therapy (i.e. chemotherapy, endocrine therapy, and radiotherapy) at study entry (baseline) is reported. |
| Participants With Disease History at Study Entry (Baseline) | Baseline (Day 1) | Participant's history at the time of diagnosis of metastatic disease and sites of metastases is reported at study entry (baseline). |
| Participants With Type of Metastases at Study Entry (Baseline) | Baseline (Day 1) | The type of metastases (bone and visceral) are reported at study entry (baseline) is reported. |
| Participants With Proteinuria at Study Entry (Baseline) | Baseline (Day 1) | The number of participants with proteinurea status as positive, negative or missing is reported. |
| Participants With Eastern Cooperative Oncology Group Status at Study Entry | Baseline (Day 1) | The Eastern Cooperative Oncology Group (ECOG) status for participants was categorized as 0, 1, 2, or missing. ECOG has 4 grades as: 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care, totally confined to bed/chair. |
Countries
Hungary
Participant flow
Recruitment details
A total of 220 participants were enrolled across 34 centers in Hungary from 20 December 2007 to 08 March 2011.
Participants by arm
| Arm | Count |
|---|---|
| Paclitaxel + Bevacizumab Arm Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol. | 220 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 34 |
| Overall Study | Death | 3 |
| Overall Study | Disease progression | 136 |
| Overall Study | Investigator decision | 10 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Patient refused further treatment | 10 |
| Overall Study | Reimbursement limit | 9 |
Baseline characteristics
| Characteristic | Paclitaxel + Bevacizumab Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 33 Participants |
| Age, Categorical Between 18 and 65 years | 187 Participants |
| Sex/Gender, Customized Female | 218 participants |
| Sex/Gender, Customized Male | 1 participants |
| Sex/Gender, Customized Missing/unknown | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 68 / 220 |
| serious Total, serious adverse events | 19 / 220 |
Outcome results
Primary
Progression Free Survival
Progression free survival (PFS) was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment.
Time frame: Approximately 5 years
Population: All enrolled participants were considered for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paclitaxel + Bevacizumab Arm | Progression Free Survival | 9.3 months |
Secondary
One Year Survival
The status of participants whether alive, dead, unknown or missing one year after the start of bevacizumab treatment is reported.
Time frame: Approximately 5 years
Population: All enrolled participants were considered for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paclitaxel + Bevacizumab Arm | One Year Survival | Died | 37 participants |
| Paclitaxel + Bevacizumab Arm | One Year Survival | Unknown | 13 participants |
| Paclitaxel + Bevacizumab Arm | One Year Survival | Missing | 20 participants |
| Paclitaxel + Bevacizumab Arm | One Year Survival | Alive | 150 participants |
Secondary
Participants With Disease History at Study Entry (Baseline)
Participant's history at the time of diagnosis of metastatic disease and sites of metastases is reported at study entry (baseline).
Time frame: Baseline (Day 1)
Population: All enrolled participants were considered for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paclitaxel + Bevacizumab Arm | Participants With Disease History at Study Entry (Baseline) | At time of initial diagnosis | 44 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Disease History at Study Entry (Baseline) | < = 2 years after diagnosis | 91 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Disease History at Study Entry (Baseline) | > 2 years after diagnosis | 79 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Disease History at Study Entry (Baseline) | Missing | 6 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Disease History at Study Entry (Baseline) | Metastatic site, bone | 101 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Disease History at Study Entry (Baseline) | Metastatic site, lung | 96 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Disease History at Study Entry (Baseline) | Metastatic site, liver | 65 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Disease History at Study Entry (Baseline) | Metastatic site, other | 127 participants |
Secondary
Participants With Eastern Cooperative Oncology Group Status at Study Entry
The Eastern Cooperative Oncology Group (ECOG) status for participants was categorized as 0, 1, 2, or missing. ECOG has 4 grades as: 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care, totally confined to bed/chair.
Time frame: Baseline (Day 1)
Population: All enrolled participants were considered for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paclitaxel + Bevacizumab Arm | Participants With Eastern Cooperative Oncology Group Status at Study Entry | ECOG stage 0 | 164 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Eastern Cooperative Oncology Group Status at Study Entry | ECOG stage 1 | 45 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Eastern Cooperative Oncology Group Status at Study Entry | ECOG stage 2 | 7 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Eastern Cooperative Oncology Group Status at Study Entry | Missing | 4 participants |
Secondary
Participants With Hormone Receptor Status at Diagnosis
The hormone receptor status for Oestrogen (ER), Progesterone (PgR) and Human epidermal growth factor receptor (HER-2) is reported as positive, negative, unknown or missing.
Time frame: Baseline (Day 1)
Population: All enrolled participants were considered for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paclitaxel + Bevacizumab Arm | Participants With Hormone Receptor Status at Diagnosis | ER positive | 98 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Hormone Receptor Status at Diagnosis | ER negative | 117 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Hormone Receptor Status at Diagnosis | ER unknown | 3 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Hormone Receptor Status at Diagnosis | ER missing | 2 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Hormone Receptor Status at Diagnosis | PgR positive | 90 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Hormone Receptor Status at Diagnosis | PgR negative | 125 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Hormone Receptor Status at Diagnosis | PgR unknown | 3 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Hormone Receptor Status at Diagnosis | PgR missing | 2 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Hormone Receptor Status at Diagnosis | HER-2 positive | 5 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Hormone Receptor Status at Diagnosis | HER-2 negative | 212 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Hormone Receptor Status at Diagnosis | HER-2 unknown | 2 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Hormone Receptor Status at Diagnosis | HER-2 missing | 1 participants |
Secondary
Participants With Prior Therapy at Study Entry (Baseline)
The status of prior therapy (i.e. chemotherapy, endocrine therapy, and radiotherapy) at study entry (baseline) is reported.
Time frame: Baseline (Day 1)
Population: All enrolled participants were considered for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paclitaxel + Bevacizumab Arm | Participants With Prior Therapy at Study Entry (Baseline) | Prior endocrine treatment, Yes | 64 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Prior Therapy at Study Entry (Baseline) | Prior endocrine treatment, No | 152 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Prior Therapy at Study Entry (Baseline) | Prior endocrine treatment, Unknown | 1 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Prior Therapy at Study Entry (Baseline) | Prior endocrine treatment, Missing | 3 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Prior Therapy at Study Entry (Baseline) | Prior radiotherapy, Yes | 135 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Prior Therapy at Study Entry (Baseline) | Prior radiotherapy, No | 80 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Prior Therapy at Study Entry (Baseline) | Prior radiotherapy, Unknown | 2 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Prior Therapy at Study Entry (Baseline) | Prior radiotherapy, Missing | 3 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Prior Therapy at Study Entry (Baseline) | Previous chemotherapy, Yes | 127 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Prior Therapy at Study Entry (Baseline) | Previous chemotherapy, No | 83 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Prior Therapy at Study Entry (Baseline) | Previous chemotherapy, Unknown | 2 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Prior Therapy at Study Entry (Baseline) | Previous chemotherapy, Missing | 8 participants |
Secondary
Participants With Proteinuria at Study Entry (Baseline)
The number of participants with proteinurea status as positive, negative or missing is reported.
Time frame: Baseline (Day 1)
Population: All enrolled participants were considered for this outcome measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paclitaxel + Bevacizumab Arm | Participants With Proteinuria at Study Entry (Baseline) | Positive | 3 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Proteinuria at Study Entry (Baseline) | Negative | 215 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Proteinuria at Study Entry (Baseline) | Missing | 2 participants |
Secondary
Participants With Tumor Stage at Diagnosis
Number of participants at each Metastatic breast cancer stage 0, I, II, III or IV, at the point of diagnosis is reported.
Time frame: Baseline (Day 1)
Population: All enrolled participants were considered for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paclitaxel + Bevacizumab Arm | Participants With Tumor Stage at Diagnosis | Tumor stage 0 | 1 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Tumor Stage at Diagnosis | Tumor stage I | 38 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Tumor Stage at Diagnosis | Tumor stage II | 87 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Tumor Stage at Diagnosis | Tumor stage III | 39 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Tumor Stage at Diagnosis | Tumor stage IV | 50 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Tumor Stage at Diagnosis | Missing | 5 participants |
Secondary
Participants With Type of Metastases at Study Entry (Baseline)
The type of metastases (bone and visceral) are reported at study entry (baseline) is reported.
Time frame: Baseline (Day 1)
Population: All enrolled participants were considered for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paclitaxel + Bevacizumab Arm | Participants With Type of Metastases at Study Entry (Baseline) | Only Bone metastases, Yes | 16 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Type of Metastases at Study Entry (Baseline) | Only Bone metastases, No | 196 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Type of Metastases at Study Entry (Baseline) | Only Bone metastases, Missing | 8 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Type of Metastases at Study Entry (Baseline) | Only Visceral metastases, Yes | 113 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Type of Metastases at Study Entry (Baseline) | Only Visceral metastases, No | 100 participants |
| Paclitaxel + Bevacizumab Arm | Participants With Type of Metastases at Study Entry (Baseline) | Only Visceral metastases, Missing | 7 participants |
Secondary
Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry
PFS was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment for participants with triple negative status and not triple negative status.
Time frame: Approximately 5 years
Population: All enrolled participants were considered for this outcome measure. Out of the total 220 enrolled participants, 106 participants were triple negative, 110 were not triple negative and data for 4 participants were missing.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Paclitaxel + Bevacizumab Arm | Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry | Triple negative (n=106) | 8.30 months |
| Paclitaxel + Bevacizumab Arm | Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry | Not triple negative (n=110) | 13.30 months |
Secondary
Time to Discontinuation (TTD) of Bevacizumab Treatment
Time to treatment discontinuation is defined as the time to change of therapy due to any cause (tumour progression, toxicity, or other causes) from the start of bevacizumab treatment.
Time frame: Approximately 5 years
Population: All enrolled participants were considered for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paclitaxel + Bevacizumab Arm | Time to Discontinuation (TTD) of Bevacizumab Treatment | 7.0 months |