Phase 2
Completed N=21
Pazopanib in Treating Patients With Recurrent or Metastatic Breast Cancer
Breast Cancer · Recurrent Breast Cancer · Stage IV Breast Cancer
Source: ClinicalTrials.gov NCT00509587 ↗
Enrolled (actual)
21
Serious AEs
4.8%
Results posted
Dec 2016
Primary outcomePrimary: Number of Participants With Partial and Complete Response. — 1 participant
Summary
This phase II trial is studying how well giving pazopanib works in treating patients with recurrent or metastatic invasive breast cancer. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Partial and Complete Response. |
1 | — |
| SECONDARY Duration of Objective Response |
— | — |
| SECONDARY Duration of Stable Disease |
5.3 | — |
| SECONDARY Progression-free Survival |
22 | — |
| SECONDARY Overall Survival |
12.8 | — |
| SECONDARY Adverse Events Graded According to the NCI CTCAE Version 3.0 |
14; 14; 14; 5 | — |
Eligibility Criteria
Criteria:
- No prior bevacizumab
- Histologically or cytologically confirmed invasive breast carcinoma (recurrent or metastatic disease)
- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan
- Patients who may still benefit from hormonal therapy are ineligible (patients with hormone receptor-positive breast cancer should have received appropriate sequential hormonal therapy for metastatic disease until disease progression)
- Patients with HER-2 positive disease who have not yet received trastuzumab (Herceptin®) to maximal benefit are ineligible (patients with disease progression during trastuzumab therapy are eligible)
- No known brain metastases
- ECOG performance status (PS) 0-1 or Karnofsky PS 60-100%
- Life expectancy > 12 weeks
- Absolute neutrophil count >= 1,500/mm³
- Platelets >=100,000/mm³
- Total bilirubin normal (exception made for patients with known Gilbert's disease)
- AST/ALT = +1 on two consecutive dipsticks taken >= 1 week apart
- PT/INR/PTT = = 500 msecs) or other significant ECG abnormalities
- No condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, or active peptic ulcer disease) that would impair ability to swallow and retain study drug
- No poorly controlled hypertension (systolic blood pressure [BP] >= 140 mm Hg or diastolic BP >= 90 mm Hg) Initiation or adjustment of BP medication is allowed prior to study entry provided that the average of 3 BP readings prior to study entry is = 3,000/mm³
- No more than 2 prior palliative systemic chemotherapy regimens for de novo metastatic disease
- Creatinine normal OR creatinine clearance >= 60 mL/min
- At least 3 months since prior trastuzumab
Data sourced from ClinicalTrials.gov (NCT00509587). 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.