Breast Cancer
Conditions
Brief summary
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.
Detailed description
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
Interventions
DRUGtrastuzumab, docetaxel and carboplatin in dose dense regimen
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
Sponsors
Aventis Pharmaceuticals
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HER-2 overexpressing breast cancer * Clinical stage 2-3B * Normal ejection fraction
Exclusion criteria
* Metastatic disease * Low ejection fraction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Pathologic Complete Response (pCR) | determined at the time of surgery which is approximately 16 weeks from the beginning of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | from the first dose of chemotherapy until surgery which was approximately 16 weeks. | the number of patients with grade 4 (severe) toxicities and or hospitalizations were measured to assess safety and tolerability |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 treat with taxotere, herceptin, carboplatin in dose dense fashion | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants |
| Age Continuous | 51 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 44 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 / 46 |
| serious Total, serious adverse events | 1 / 46 |
Outcome results
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.
Time frame: determined at the time of surgery which is approximately 16 weeks from the beginning of treatment
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Number of Patients With Pathologic Complete Response (pCR) | 19 participants |
Secondary
Safety and Tolerability
the number of patients with grade 4 (severe) toxicities and or hospitalizations were measured to assess safety and tolerability
Time frame: from the first dose of chemotherapy until surgery which was approximately 16 weeks.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Safety and Tolerability | 1 participants |