Breast Cancer
Conditions
Brief summary
This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without progression for at least three years. Patients will be followed prospectively for one year.
Interventions
DRUGTrastuzumab
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients, \>/= 18 years of age * HER2-positive metastatic breast cancer or locally advanced breast cancer * Systemic treatment included Herceptin as 1st line therapy * Without progression for at least 3 years after the beginning of Herceptin treatment * Alive or not alive and treated or not treated with Herceptin at the time of inclusion
Exclusion criteria
* Disease progression \<3 years after beginning 1st-line therapy with Herceptin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Hormone Receptor Status of Participants Without Progression | Up to 3 years | The clinical and tumor characteristics including HER2 and Hormone Receptor (HR) status of metastatic breast cancer participants are analysed which are important factors which impact on Progression Free Survival. |
| Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment | Up to 3 years | Bone metastasis occurs when cancer cells spread from their original site to a bone. Percentage of participants with prevalence of bone metastases without progression were reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to 12 years | The overall survival (OS) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the death from any cause. |
| Dosage Schedule of Herceptin Treatment | Up to 12 years | Participants who received trastuzumab are reported in the below table. The regimen of trastuzumab in first line treatment is presented as in frequency 1 infusion (inf) per week (W) and dose per infusion as mg/kg. |
| Progression-free Survival | Up to 12 years | The Progression-free survival (PFS) was defined as the time between the treatment start date (date of first trastuzumab infusion during the metastatic period) and the date of the first progressive disease or death from any cause. The method of assessment of disease progression was not outlined within the protocol, this was completed by each investigator in line with routine practice. |
| Number of Participants With Any Adverse Events and Serious Adverse Events | Up to 1 year | An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The data was reported for prospective period. |
| The Duration of Treatment of Trastuzumab | Up to 1 Year | Total treatment duration and duration of the first line of treatment is reported. |
| Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment | Up to 12 years | Antineoplastic treatment given in combination with and after discontinuation (Aft. Dis) of herceptin treatment included chemotherapy and hormonotherapy. |
| Time to Progression | Up to 12 years | The Time to progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the date of the first progressive disease. |
Countries
France
Participant flow
Recruitment details
A total of 160 participants were recruited from 28 March 2011 to 16 November 2012.
Participants by arm
| Arm | Count |
|---|---|
| Trastuzumab Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year. | 128 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 23 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | visit not done | 10 |
Baseline characteristics
| Characteristic | Trastuzumab |
|---|---|
| Age, Continuous | 61.3 Years STANDARD_DEVIATION 12.2 |
| Sex: Female, Male Female | 128 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 30 / 134 |
| serious Total, serious adverse events | 6 / 134 |
Outcome results
Primary
Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment
Bone metastasis occurs when cancer cells spread from their original site to a bone. Percentage of participants with prevalence of bone metastases without progression were reported
Time frame: Up to 3 years
Population: Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at the time of evaluation were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trastuzumab | Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment | 42.5 Percentage of participants |
Primary
Tumor Hormone Receptor Status of Participants Without Progression
The clinical and tumor characteristics including HER2 and Hormone Receptor (HR) status of metastatic breast cancer participants are analysed which are important factors which impact on Progression Free Survival.
Time frame: Up to 3 years
Population: Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at the time of evaluation were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trastuzumab | Tumor Hormone Receptor Status of Participants Without Progression | HR Positive | 57.6 Percentage of participants |
| Trastuzumab | Tumor Hormone Receptor Status of Participants Without Progression | HR Negative | 42.4 Percentage of participants |
Secondary
Dosage Schedule of Herceptin Treatment
Participants who received trastuzumab are reported in the below table. The regimen of trastuzumab in first line treatment is presented as in frequency 1 infusion (inf) per week (W) and dose per infusion as mg/kg.
Time frame: Up to 12 years
Population: Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at specified time points are denoted as 'n'.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trastuzumab | Dosage Schedule of Herceptin Treatment | Dose and frequency of inf:1 inf / W, n= 125 | 40 Participants |
| Trastuzumab | Dosage Schedule of Herceptin Treatment | 1 inf/2W, n= 125 | 2 Participants |
| Trastuzumab | Dosage Schedule of Herceptin Treatment | 1 inf / 3W, n= 125 | 82 Participants |
| Trastuzumab | Dosage Schedule of Herceptin Treatment | 3 inf/4W, n= 125 | 1 Participants |
| Trastuzumab | Dosage Schedule of Herceptin Treatment | Dose per inf: 2 mg/kg, n= 124 | 10 Participants |
| Trastuzumab | Dosage Schedule of Herceptin Treatment | 3 mg/kg, n= 124 | 1 Participants |
| Trastuzumab | Dosage Schedule of Herceptin Treatment | 4 mg/kg, n= 124 | 39 Participants |
| Trastuzumab | Dosage Schedule of Herceptin Treatment | 6 mg/kg, n= 124 | 25 Participants |
| Trastuzumab | Dosage Schedule of Herceptin Treatment | 8 mg/kg, n= 124 | 49 Participants |
Secondary
Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment
Antineoplastic treatment given in combination with and after discontinuation (Aft. Dis) of herceptin treatment included chemotherapy and hormonotherapy.
Time frame: Up to 12 years
Population: Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at specified time points are denoted as 'n'.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trastuzumab | Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment | With Trastuzumab, Chemotherapy, n= 119 | 117 Participants |
| Trastuzumab | Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment | With Trastuzumab, Hormonotherapy, n= 51 | 50 Participants |
| Trastuzumab | Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment | Aft. Dis, Chemotherapy n= 128 | 22 Participants |
| Trastuzumab | Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment | Aft. Dis, hormonotherapy n= 128 | 4 Participants |
Secondary
Number of Participants With Any Adverse Events and Serious Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The data was reported for prospective period.
Time frame: Up to 1 year
Population: The safety population set included of all participants who received at least one dose of study drug. Participants with available data in the prospective period were analysed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trastuzumab | Number of Participants With Any Adverse Events and Serious Adverse Events | Any AEs | 30 Participants |
| Trastuzumab | Number of Participants With Any Adverse Events and Serious Adverse Events | Any SAEs | 6 Participants |
Secondary
Overall Survival
The overall survival (OS) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the death from any cause.
Time frame: Up to 12 years
Population: Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Trastuzumab | Overall Survival | NA Years |
Secondary
Progression-free Survival
The Progression-free survival (PFS) was defined as the time between the treatment start date (date of first trastuzumab infusion during the metastatic period) and the date of the first progressive disease or death from any cause. The method of assessment of disease progression was not outlined within the protocol, this was completed by each investigator in line with routine practice.
Time frame: Up to 12 years
Population: Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Trastuzumab | Progression-free Survival | 6.44 Years |
Secondary
The Duration of Treatment of Trastuzumab
Total treatment duration and duration of the first line of treatment is reported.
Time frame: Up to 1 Year
Population: Analyzed Set population included all enrolled participants without any protocol deviation used as a primary analysis population for all efficacy outcome measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trastuzumab | The Duration of Treatment of Trastuzumab | First line of treatment | 4.89 Years | Standard Deviation 2.13 |
| Trastuzumab | The Duration of Treatment of Trastuzumab | Total treatment duration | 5.57 Years | Standard Deviation 2.36 |
Secondary
Time to Progression
The Time to progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the date of the first progressive disease.
Time frame: Up to 12 years
Population: Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Trastuzumab | Time to Progression | 6.44 Years |