Phase 2
N=32
Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00093145 ↗Enrolled (actual)
32
Serious AEs
15.6%
Results posted
Jul 2013
Primary outcome: Primary: Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response — 62.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Albumin-bound paclitaxel (Drug); Carboplatin (Drug); Herceptin® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Celgene
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response |
62.5 | — |
| SECONDARY Percentage of Participants With a Total Response |
81.3 | — |
| SECONDARY Time to Disease Progression |
16.6 | — |
| SECONDARY Duration of Response |
17.8 | — |
| SECONDARY Overall Patient Survival |
NA | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
32; 31; 20; 5 | — |
Summary
This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.
Eligibility Criteria
Inclusion Criteria
- Confirmed adenocarcinoma of the breast
- Tumor shows 3+ overexpression of the human epidermal growth factor receptor 2 (HER-2)/proto-oncogene by immunohistochemistry assay, or is fluorescence in situ hybridization (FISH)+
- Stage IV disease
- Measurable disease
- At least 3 weeks since prior cytotoxic chemotherapy
- At least 4 weeks since radiotherapy with full recovery
- At least 4 weeks since major surgery with full recovery
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- At least 18 years old
- Absolute neutrophil count (ANC) at least 1.5 x 10^9 cells/L
- Platelets at least 100 x 10^9 cells/L
- Hemoglobin at least 9 g/dL
- Aspartame aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5X upper limit normal
- Alkaline Phosphatase less than 1.5X upper limit normal
- Creatinine less than 1.5 gm/dL
- Normal left ventricular ejection fraction
- Negative pregnancy test
- Agree to use method to avoid pregnancy
- Informed Consent is obtained
Exclusion Criteria
- Up to one regimen of prior neo-adjuvant or adjuvant chemotherapy is allowed. One year since Taxane and Herceptin treatment.
- Cumulative life-time dose of doxorubicin is greater than 360 mg/m^2
- Concurrent immunotherapy or hormonal therapy
- Parenchymal brain metastases, if present, must be documented to be clinically and radiographically stable for at least 6 months after treatment
- Serious intercurrent medical or psychiatric illness, including serious active infection
- History of congestive heart failure
- History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer
- Patients who have received an investigational drug within the previous 3 weeks
- Patient is currently enrolled in another clinical study receiving investigational therapies
- Pregnant or nursing women
Data sourced from ClinicalTrials.gov (NCT00093145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.