Clinical trial · Interventional
Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer
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
NCT00093145CI-TRIAL-00041908completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Albumin-bound paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Herceptin® | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Albumin-bound paclitaxel, Carboplatin + Herceptin
- description
- Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
- interventionNames
- Drug: Albumin-bound paclitaxel
- Drug: Carboplatin
- Drug: Herceptin®
Primary outcomes (1)
- measure
- Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response
- timeFrame
- Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTConlin AK, Seidman AD, Bach A, Lake D, Dickler M, D'Andrea G, Traina T, Danso M, Brufsky AM, Saleh M, Clawson A, Hudis CA. Phase II trial of weekly nanoparticle albumin-bound paclitaxel with carboplatin and trastuzumab as first-line therapy for women with HER2-overexpressing metastatic breast cancer. Clin Breast Cancer. 2010 Aug 1;10(4):281-7. doi: 10.3816/CBC.2010.n.036. PMID 20705560