Breast Cancer
Conditions
Keywords
Breast Cancer
Brief summary
This trial combines trastuzumab and bevacizumab monoclonal antibodies, with ABI-007 and carboplatin, as neoadjuvant therapy in previously untreated locally advanced breast cancers demonstrating HER2 gene amplification. It is hoped that this novel combination will result in increased pathologic response rates that will translate into long term outcome improvements in HER2 positive patients with locally advanced breast cancer.
Detailed description
All eligible patients will receive induction chemotherapy prior to consideration of primary surgical intervention. If surgical intervention is deemed not to be in the best interest of the patient, patient will go off study at the time of evaluation for surgery. Upon completion of chemotherapy and surgery, all ER + and/or PR + patients will be placed on Tamoxifen 20 mg/qd or an aromatase inhibitor. Induction preoperative therapy: * Bevacizumab * Trastuzumab * ABI-007 * Carboplatin Postoperative Adjuvant Therapy: * Bevacizumab * Trastuzumab
Interventions
DRUGnab-paclitaxel
ABI-007
DRUGBevacizumab
Bevacizumab
DRUGTrastuzumab
Trastuzumab
Sponsors
Celgene Corporation
Genentech, Inc.
SCRI Development Innovations, LLC
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
* Female patients with histologically confirmed adenocarcinoma of the breast or inflammatory breast cancer * Clinical stage T 1-4, N 0-3, M0 * FISH+ HER2 gene amplified breast cancer * 18 years or older * Normal cardiac function * Performance status 0-2 * Cannot have received any prior chemotherapy for this disease or cannot have received chemotherapy for any other cancer in the past 5 years. * Previous diagnosis of noninvasive breast cancer is OK. * Must have adequate bone marrow, renal and liver function. * Pregnant or lactating females not allowed. * Preexisting peripheral neuropathy must be equal to or less than grade 1 * Must have archived tumor tissue for tissue testing.
Exclusion criteria
You cannot be in this study if you any of the following: * History of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure * Any heart attack, stroke or TIAs within the last 6 months or serious arrhythmias needing medication; no bleeding diathesis or coagulopathy. * No prior investigational drug within the last 30 days * No prior trastuzumab or bevacizumab therapy There are additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in the Breast or Lymph Nodes Following Surgery | 18 months | Pathologic complete response was defined as the absence of residual invasive cancer in the breast (pT0) and axillary lymph nodes (pN0). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nab-Paclitaxel/Bevacizumab/Trastuzumab Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks. | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Nab-Paclitaxel/Bevacizumab/Trastuzumab |
|---|---|
| Age Continuous | 52 years |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 29 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 | 29 / 29 |
| serious Total, serious adverse events | 8 / 29 |
Outcome results
Primary
Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in the Breast or Lymph Nodes Following Surgery
Pathologic complete response was defined as the absence of residual invasive cancer in the breast (pT0) and axillary lymph nodes (pN0).
Time frame: 18 months
Population: Two patients refused surgery after completing six cycles of pre-operative (neoadjuvant) therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nab-Paclitaxel/Bevacizumab/Trastuzumab | Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in the Breast or Lymph Nodes Following Surgery | 56 percentage of participants |