Clinical trial · Interventional
First Line Therapy for Patients With Metastatic Breast Cancer
An Open-Label, Phase II Study of Weekly ABI-007 as First Line Therapy for Patients With Metastatic Breast Cancer
NCT00456846CI-TRIAL-00041861terminatedPhase 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)
The purpose of this study is to determine the toxicity and anti-tumor activity of nab-paclitaxel 100mg/m\^2 administered weekly in a 4-week cycle as first line therapy to patients with metastatic breast cancer who received taxanes as part of their adjuvant therapy and patients who did not receive taxanes as part of their adjuvant therapy.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABI-007 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ABI-007
- description
- 100 mg/m\^2 ABI-007 was administered by intravenous (IV) infusion over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.
- interventionNames
- Drug: ABI-007
Primary outcomes (1)
- measure
- Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers
- timeFrame
- Every 8 weeks from study start until disease progression; Up to 61 months
- description
- Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females with pathologically confirmed adenocarcinoma of the breast. * No prior chemotherapy for metastatic breast cancer * At least 12 months between completion of adjuvant chemotherapy and the diagnosis of metastatic disease * Stage IV disease * Measurable disease (must be equal or greater to 2.0 cm using conventional Computed Tomography (CT) or equal or greater to 1.0 cm using spiral CT except for pulmonary lesions that are well documented on conventional CT scan which must be equal or greater than 1.0 cm) * At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be radiologic or clinical exam proof of progressive disease within the radiation portal * At least 4 weeks since major surgery, with full recovery * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Age equal or greater to 18 * Patients has the following blood counts at Baseline: * Absolute Neutrophil Count (ANC) equal or greater to 1.5 x 10\^9 cells/L * Platelets equal or greater to 100 x 10\^9 cells/L * Hemoglobin (Hgb) equal or greater to 90 grams/L * Patients has the following blood chemistry levels at Baseline: * Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT) serum glutamic:pyruvic transaminase (SGPT)less than or equal to 2.5x upper limit of normal range (ULN); * total bilirubin normal (unless bilirubin elevation is due to Gilbert's (Disease); * alkaline phosphatase less than or equal 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis); * Creatinine less than or equal to 1.5mg/dL * Current sensory neuropathy Grade 0 or 1 by Breast Cancer Index (BCI) Common Toxicity Criteria Adverse Events (CTCAE) * If female of childbearing potential, pregnancy test is negative (within 72 hours of the first dose of study drug). * If fertile, the patient agrees to use an effective method of contraception to avoid pregnancy for the duration of the study * Patient is able to supply unstained slides or 1 tumor block of her primary breast tumor or a biopsy of a current site of metastasis for Secreted protein acidic and rich in cysteine (SPARC) analysis * Informed consent has been obtained Exclusion Criteria: * Concurrent immunotherapy or hormonal therapy (other than Herceptin) for breast cancer * Parenchymal brain metastases, unless 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 class II-IV congestive heart failure * History of other malignancy within the last 5 years which could affect the diagnoses or assessment of breast cancer, with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * Patients who have received an investigational drug within the previous 3 weeks * Patient is currently enrolled in a different clinical study in which investigational procedures are performed or investigational therapies are administered. Also a patient may not enroll in such clinical trials while participating in this study. * Pregnant or nursing women * Patients with prior hypersensitivity to Taxol or Taxotere
References
Publications (1)
- BACKGROUNDBrezden B, et al. An open-label, phase II study of weekly nab-paclitaxel as first-line therapy for patients (pts) with metastatic breast cancer (MBC): Safety update. Presented at 2010 ASCO Annual Meeting, June 4-8, 2010, Chicago, IL. Abstract No 1127 C.