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The sample for statistical analysis of results could not be recruited within the specified timeframe upon retirement of the original principal investigator.
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This single arm study will assess the efficacy and safety of combination first-line treatment with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast cancer. Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after Avastin) and Xeloda (2000mg/m2 p.o. on days 1-15 of each cycle). Four cycles of chemotherapy are planned, plus an optional additional two cycles; after chemotherapy patients will be assessed for surgery. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab [Avastin] | Drug | 15mg/kg iv on day 1 of each 3 week cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Pathological Complete Response (pCR) | pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected. | At time of surgery, after receiving up to 6 cycles of treatment (average of 12 to 18 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR) | The percentage of participants with a best overall response of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). 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 aixs 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madrid | Madrid | 28041 | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab+Docetaxel+Capecitabine | Participants received bevacizumab 15 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1; docetaxel 75 mg per square meter (mg/m^2), IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Docetaxel |
| Drug |
75mg/m2 iv on day 1 of each 3 week cycle |
|
| Xeloda | Drug | 2000mg/m2 po on days 1-15 of each 3 week cycle |
|
| Day 1 of Cycles 1-6 |
| Progression-Free Survival | Progression-free survival was defined as the time from the date of informed consent until the date disease progression was identified, or the date of death from disease progression, whichever occurred first. | Cycles 1-6 |
| Overall Survival | Overall survival was defined as the time from the date of informed consent until the date of death due to any cause. | Cycles 1-6 |
| Percentage of Participants Undergoing Breast-Conserving Surgery | The percentage of participants who were able to undergo breast-conserving surgical procedures (segmentectomy plus lymphadenectomy or quadrantectomy plus lymphadenectomy) rather than non-breast conserving procedures (radical mastectomy or modified-radical mastectomy) following 4 or more treatment cycles. | Following Cycle 6 |
| COMPLETED |
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| NOT COMPLETED |
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|
Intent-to-treat (ITT) population. The ITT population included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab+Docetaxel+Capecitabine | Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Pathological Complete Response (pCR) | pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected. | Evaluable Response (ER) Population: study-eligible participants who completed at least 2 treatment cycles; had lesions evaluated using the same technique at baseline and at least once after receiving the second treatment cycle; and had no major protocol deviation. | Posted | Number | percentage of participants | At time of surgery, after receiving up to 6 cycles of treatment (average of 12 to 18 weeks) |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR) | The percentage of participants with a best overall response of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). 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 aixs 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. | ER population | Posted | Number | percentage of participants | Day 1 of Cycles 1-6 |
|
| |||||||||||||||||||||||||||
| Secondary | Progression-Free Survival | Progression-free survival was defined as the time from the date of informed consent until the date disease progression was identified, or the date of death from disease progression, whichever occurred first. | The application of a statistical model for the analysis of disease-free survival was not feasible as the sample size required for statistical analysis could not be recruited within the time established in the protocol and the study was terminated. | Posted | Cycles 1-6 |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the time from the date of informed consent until the date of death due to any cause. | The application of a statistical model for the analysis of disease-free survival is not feasible as the sample size required for statistical analysis could not be recruited within the time established in the protocol and the study was terminated. | Posted | Cycles 1-6 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Undergoing Breast-Conserving Surgery | The percentage of participants who were able to undergo breast-conserving surgical procedures (segmentectomy plus lymphadenectomy or quadrantectomy plus lymphadenectomy) rather than non-breast conserving procedures (radical mastectomy or modified-radical mastectomy) following 4 or more treatment cycles. | ITT population. | Posted | Number | percentage of participants | Following Cycle 6 |
|
|
Throughout study
The safety population included all participants who received at least 1 dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab+Docetaxel+Capecitabine | Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment. | 2 | 23 | 23 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Hand-foot syndrome | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Nail toxicity | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Mucous membrane inflammation | General disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Upper abdominal pain | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Vaginal bleeding | Reproductive system and breast disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Abnormal liver function test | Investigations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Palpebral edema | Eye disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Urinary tract infections | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
The Study being conducted under this agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request the Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077143 | Docetaxel |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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