Phase 2
Completed N=50
ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00110084 ↗Enrolled (actual)
50
Serious AEs
22.0%
Results posted
May 2011
Primary outcomePrimary: Proportion of Patients With Confirmed Responses — 25; 50 participants
Summary
RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Confirmed Responses |
25; 50 | — |
| SECONDARY Progression-free Survival |
7.9 | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Adverse Event |
27; 14; 7; 7; 6; 4 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed invasive breast cancer
- Clinical evidence of metastatic disease
+ No bone metastases or other non-measurable disease as the only evidence of metastasis
- Measurable disease, defined as at least 1 measurable lesion
- The following are considered non-measurable disease:
- Small lesions ( grade 1
- No other clinically significant illness or significant medical condition that would preclude study participation
- No history of allergy or hypersensitivity to paclitaxel protein-bound particles in an injectable suspension, paclitaxel, gemcitabine, albumin, drug product excipients, or agents that are chemically similar to study drugs
- No serious medical risk factors involving any of the major organ systems that would preclude study participation
- No active stage III or IV invasive non-breast malignancy within the past 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics Chemotherapy
- No more than 1 prior adjuvant chemotherapy regimen
- No prior chemotherapy for metastatic disease
- At least 6 months since prior adjuvant or neoadjuvant taxane
- More than 2 weeks since prior cytotoxic chemotherapy
- Prior neoadjuvant chemotherapy allowed
- No other concurrent chemotherapy Endocrine therapy
- Prior hormonal treatment as adjuvant therapy or for metastatic disease allowed Radiotherapy
- Prior radiotherapy to target lesion allowed provided there is evidence of disease progression after completion of treatment
- More than 2 weeks since prior radiotherapy, except radiotherapy to a non-target lesion only or single-dose palliative radiotherapy
- No concurrent radiotherapy Surgery
- Not specified Other
- More than 2 weeks since prior investigational drugs
- No concurrent participation in another clinical trial that is studying investigational procedures or therapies
- Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed for palliation of pain or lytic lesions from breast cancer
Data sourced from ClinicalTrials.gov (NCT00110084). 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. Informational only — not medical advice.