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| Name | Class |
|---|---|
| Aventis Pharmaceuticals | INDUSTRY |
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Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.
Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm 1 | Experimental | single arm study evaluating the efficacy of neoadjuvant taxotere, herceptin and carboplatin given in a dose dense fashion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab, docetaxel and carboplatin in dose dense regimen | Drug | trastuzumab 4 mg/kg day 1 and then 2 mg/kg/week x 11, carboplatin 6 mg AUC Day 1, 15, 29, 43, docetaxel 75 mg/meter squared Days 1, 15, 29, 43, neulasta 6 mg Day 2, 16, 30, 44 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Pathologic Complete Response (pCR) | pCR is defined as the absence of invasive tumor from the surgical specimen of breast and axilla which is obtained after the chemotherapy regimen has been delivered. | determined at the time of surgery which is approximately 16 weeks from the beginning of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | the number of patients with grade 4 (severe) toxicities and or hospitalizations were measured to assess safety and tolerability | from the first dose of chemotherapy until surgery which was approximately 16 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Hurley | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | study group receives taxotere, herceptin and carboplatin in dose dense fashion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | treat with taxotere, herceptin, carboplatin in dose dense fashion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Number of Patients With Pathologic Complete Response (pCR) | pCR is defined as the absence of invasive tumor from the surgical specimen of breast and axilla which is obtained after the chemotherapy regimen has been delivered. | 48 patients signed consent but only 44 were evaluable. To be evaluable the patient must have received at least one dose of chemo and then had surgery. Two patients withdrew consent before treatment and two patients did not have surgery. So 44 are evaluable for the primary endpoint | Posted | Number | participants | determined at the time of surgery which is approximately 16 weeks from the beginning of treatment |
|
adverse events were collected for the 16 week pre-operative period while the study was open to accrual over a three year period.
toxicity coded and graded using the CTC 2.0
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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 | Group 1 | patients received herceptin, carboplatin, taxotere in dose dense fashion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization | Gastrointestinal disorders | Systematic Assessment | one patient hospitalized for nausea, vomiting, diarrhea and dehydration |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Hurley | UMiami | 305-243-6698 | jhurley@miami.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Safety and Tolerability | the number of patients with grade 4 (severe) toxicities and or hospitalizations were measured to assess safety and tolerability | 48 patients signed an initial informed consent. 2 withdrew consent before treatment. 2 withdrew after starting treatment. Only 44 are evaluable for primary endpoint because 2 did not go for surgery. | Posted | Number | participants | from the first dose of chemotherapy until surgery which was approximately 16 weeks. |
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|
|
| 1 |
| 46 |
| 0 |
| 46 |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| 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 |
| D056831 | Coordination Complexes |