At a glance
ClinicalIndex Comparison Record- ✓Confirmed adenocarcinoma of the breast
- ✓HER-2 3+ overexpression by immunohistochemistry or FISH positive
- ✓Stage IV disease with measurable disease
- ✓ECOG performance status 0-2
- ✕Cumulative lifetime doxorubicin dose greater than 360 mg/m²
- ✕Concurrent immunotherapy or hormonal therapy
- ✕Parenchymal brain metastases unless clinically and radiographically stable for at least 6 months post-treatment
- ✕History of congestive heart failure
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Weekly Dose-Dense Nanoparticle Paclitaxel (ABI-007), Carboplatin With Herceptin® As First-Line Therapy of Advanced HER-2 Positive Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Albumin-bound paclitaxel, Carboplatin, and 1 other intervention for Breast Cancer. Completed, enrolled 32 participants across 14 sites.
Detailed 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.
Study Details
Timeline
Interventions
Administered by intravenous infusion.
Carboplatin dose was calculated using a modified Calvert formula (creatinine clearance was substituted for GFR): Total dose (mg) = (target AUC) x (creatinine clearance + 25). Note: AUC = 6 was initially targeted, but could be decreased due to toxicity.
Administered by IV infusion