Breast Cancer
Conditions
Brief summary
This single arm. open-label study will assess the efficacy and safety of Herceptin (trastuzumab) in combination with Xeloda (capecitabine) in patients with metastatic or recurrent HER2-positive breast cancer, refractory to or relapsing after chemotherapy with Herceptin and taxanes. Patients will receive Xeloda 900mg/m2 twice daily orally on days 1-14 of each 3-week cycle and Herceptin 8mg/kg intravenously (iv) on day 1 of the first cycle followed by 6mg/kg iv every 3 weeks. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Interventions
DRUGcapecitabine [Xeloda]
900mg/m2 bid po on days 1-14 of each 3-week cycle
8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg iv every 3 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female patients, 18-65 years of age * Histologically confirmed HER2-positive breast cancer with measurable lesions (according to RECIST criteria) * Metastatic disease after first-line therapy or recurrent disease after (neo)adjuvant therapy with Herceptin and taxanes * ECOG performance status 0-2
Exclusion criteria
* CNS metastases which are not well controlled * Simultaneous treatment with sorivudine * History of another malignancy within the last 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in-situ of the uterine cervix * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Overall Response | Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death | The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Disease Progression | Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death | Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to progression is the time from the date of first dose of drug administration to the date when first disease progression is recorded. |
| Overall Survival | Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death | Overall survival (OS) is the time from the date of randomization to the date of death irrespective of the cause of death. |
| Progression-Free Survival | Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death | Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants without progression were censored at the date of last tumor assessment when non progression was documented. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Capecitabine + Trastuzumab Participants received capecitabine 900 mg/m\^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Early termination of the study | 4 |
Baseline characteristics
| Characteristic | Capecitabine + Trastuzumab |
|---|---|
| Age, Continuous | 53.75 years STANDARD_DEVIATION 9.03 |
| Sex: Female, Male Female | 4 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 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Percentage of Participants With Overall Response
The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).
Time frame: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
Population: Data were not analyzed due to early termination of the study.
Secondary
Overall Survival
Overall survival (OS) is the time from the date of randomization to the date of death irrespective of the cause of death.
Time frame: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
Population: Data were not analyzed due to early termination of the study.
Secondary
Progression-Free Survival
Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants without progression were censored at the date of last tumor assessment when non progression was documented.
Time frame: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
Population: Data were not analyzed due to early termination of the study.
Secondary
Time to Disease Progression
Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to progression is the time from the date of first dose of drug administration to the date when first disease progression is recorded.
Time frame: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
Population: Data were not analyzed due to early termination of the study.