Breast Cancer
Conditions
Brief summary
This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time on study treatment is 3-12 months.
Interventions
DRUGbevacizumab [Avastin]
15 mg/kg iv on Day 1 of each 3-week cycle, 5 cycles
DRUGdocetaxel
75 mg/m2 on Day 1 of each 3-week cycle, 6 cycles
DRUGcapecitabine [Xeloda]
950 mg/m2, orally twice daily, evening of Day 1 until morning of Day 15, followed by a 7 day rest period, 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 70 Years
Healthy volunteers
No
Inclusion criteria
* female patients, 18-70years of age; * histologically-proven invasive breast cancer; * no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix; * no distant disease/secondary cancer.
Exclusion criteria
* pregnant or lactating women; * pre-operative local treatment for breast cancer; * prior or concurrent systemic antitumor therapy; * clinically significant cardiac disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Pathological Complete Response (pCR) | Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18]) | pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR) | Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18]) | Percentage of participants with pCR plus the percentage of participants without pCR who achieved CR or PR as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than \[\<\] 10 millimeters \[mm\]). No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. |
| Percentage of Participants Undergoing Breast-Conserving Surgery | 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18]) | Percentage of participants undergoing a breast-conserving procedure versus a modified radical mastectomy at final surgery, performed 2 to 4 weeks after the last chemotherapy cycle (Week 18) |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab+Docetaxel+Capecitabine Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m\^2 IV on Day 1 and capecitabine 950 mg/m\^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Bevacizumab+Docetaxel+Capecitabine |
|---|---|
| Age, Continuous | 48 years |
| Sex: Female, Male Female | 18 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 | 18 / 18 |
| serious Total, serious adverse events | 5 / 18 |
Outcome results
Primary
Percentage of Participants With Pathological Complete Response (pCR)
pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle.
Time frame: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])
Population: ITT population; participants evaluable for response included those participants who received a minimum of 3 cycles of treatment (9 weeks on study) with final surgery performed and the samples and reports available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab+Docetaxel+Capecitabine | Percentage of Participants With Pathological Complete Response (pCR) | 22.22 percentage of participants |
Secondary
Percentage of Participants Undergoing Breast-Conserving Surgery
Percentage of participants undergoing a breast-conserving procedure versus a modified radical mastectomy at final surgery, performed 2 to 4 weeks after the last chemotherapy cycle (Week 18)
Time frame: 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab+Docetaxel+Capecitabine | Percentage of Participants Undergoing Breast-Conserving Surgery | 83 percentage of participants |
Secondary
Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR)
Percentage of participants with pCR plus the percentage of participants without pCR who achieved CR or PR as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than \[\<\] 10 millimeters \[mm\]). No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Time frame: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])
Population: ITT population; participants evaluable for response included those participants who received a minimum of 3 cycles of treatment (9 weeks on study) with final surgery performed and the samples and reports available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab+Docetaxel+Capecitabine | Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR) | 72.22 percentage of participants |