Breast Cancer Clinical Trial
Official title:
Phase II Randomized Study of Doxorubicin and Cyclophosphamide With or Without Intermittent Sunitinib in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer Patients With Measurable Primary Breast Tumor
This is a single-centre, phase II randomized study of doxorubicin and cyclophosphamide (AC)
with or without intermittent sunitinib in patients with measurable primary breast cancer who
are receiving pre-operative chemotherapy.
A lead-in phase I study was built into this protocol to determine the dose and duration of
sunitinib that may achieve the desired effects of normalizing tumor vasculature prior to
chemotherapy administration.
A total of 64 patients with measurable primary tumor will be enrolled for the Phase II part
of the study. Eligible patients will be randomized 1:1 to either arm A or arm B. Patients
will be stratified according to metastatic status (metastatic vs non-metastatic) and
presence or absence of clinical T4 disease.
Arm A (Control arm):
Doxorubicin 60mg/m2 day 1 Cyclophosphamide 600mg/m2 day1, every 3 weeks x 4 cycles
Arm B (Experimental arm):
Days -13 (or -7) to day 0 (total 7 or 14 days) - oral sunitinib daily (duration and dose as
determined from the lead-in phase I study) Cycle 1: day 1 - Cycle 1 AC (60/600mg/m2); days
15-21 - oral sunitinib daily Cycle 2: day 1 - Cycle 2 AC (60/600mg/m2); days 15-21 - oral
sunitinib daily Cycle 3: day 1 - Cycle 3 AC (60/600mg/m2); days 15-21 - oral sunitinib daily
Cycle 4: day 1 - Cycle 4 AC (60/600mg/m2)
DCE-MRI scan will be performed serially to determine tumor response and change in tumor
vascular parameters for each enrolled subject:
Patient will be evaluated weekly for toxicity assessments and full blood count during cycle
1, and on days 1 and 15 of each subsequent cycle. In addition, patients in Arm B will be
evaluated weekly during the first two weeks of sunitinib administration prior to cycle 1 AC.
Special tests Blood sampling
- Germline DNA at baseline for pharmacogenetics analysis.
- Pharmacokinetic sampling for doxorubicin and cyclophosphamide on day 1, cycle 1 of AC
administration.
- Pharmacokinetic sampling for sunitinib at baseline and weekly during the first course
of sunitinib for subjects in Arm B before the sunitinib dose on that day.
- Serial plasma samples for proteomics analysis and for analysis of soluble angiogenic
factors
- Serial whole blood for gene expression analysis
- Serial blood samples for circulating tumor and circulating endothelial cells
- DNA will be extracted from collected snap-frozen and/or paraffin-embedded tumor tissue
sections (pre- and post-treatment) and plasma (pre- and post-treatment taken for plasma
biomarker analysis). Primary tumor and circulating tumor DNA will be genotyped for
cancer genes of interest that may influence cancer prognosis and/or treatment response.
Tumor core biopsy Arm A: Performed at baseline, approximately 3 weekly after cycle 1 AC but
before cycle 2 AC, and upon completion of 4 cycles of AC, for a total of 3 tumor core
biopsies Arm B: Performed at baseline, after completing the first course of sunitinib and
before cycle 1 AC, approximately 3 weekly after cycle 1 AC but before cycle 2 AC, and upon
completion of 4 cycles of AC, for a total of 4 tumor core biopsies.
The final biopsy may be obtained at surgery if the patient is scheduled for lumpectomy or
mastectomy. The tumor cores will be stored in liquid nitrogen for subsequent DNA, RNA and
protein extraction for biomarker studies including gene expression and proteomics analyses.
Three to four samples will be obtained at each time point, and one tumor core at each time
point will be stored in formalin and paraffin-embedded for immunohistochemistry analysis of
biomarkers.
Note: Tumor biopsies, imaging and blood collection that are to be conducted after completing
the first course of sunitinib may be carried out as early as 2 days before the last dose of
sunitinib in the first course for logistics reasons.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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