Clinical trial NCT00372424: Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive
Official title: An Explorative Study Of The Tolerability Of SU011248 In Combination With Docetaxel And Trastuzumab As First-Line Treatment In Patients With Breast Cancer Over-Expressing HER-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: Breast cancer over-expressing HER2. First-line treatment with sunitinib/docetaxel/trastuzumab.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or metastatic breast cancer over-expressing Her-2, who have not received chemotherapy treatment in the advanced disease setting.


Eligibility criteria: Inclusion Criteria:

* Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
* Tumors over-expressing Her-2
* Candidate for treatment with docetaxel/trastuzumab

Exclusion Criteria:

* Histology of inflammatory carcinoma
* AST and/or ALT \>1.5 x ULN concomitant with ALP \>2.5 x ULN

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: From screening until 28 days post last dose of study drug
Secondary outcomes:
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)
measure: Progression-free Survival (PFS)
timeFrame: Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)
measure: Duration of Response (DR)
timeFrame: Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)
measure: Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662)
timeFrame: Pre-dose (0 hours [H]) on Day 1 and Day 15 of Cycle 2, 4, 6 and additionally Day 15 of Cycle 1
measure: Maximum Observed Plasma Concentration (Cmax) of Docetaxel
timeFrame: End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6
measure: Plasma Trough Concentrations (Ctrough) of Trastuzumab
timeFrame: Weekly trastuzumab: Pre-dose (0 H) on Day 1 and 15 of Cycle 1, 2, 4 and 6; 3-weekly trastuzumab: Pre-dose (0 H) on Day 1 of Cycle 1, 2, 4 and 6
Other outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Paclitaxel
timeFrame: End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Charleroi
country: Belgium
facility: Pfizer Investigational Site
city: Sint-Niklaas
country: Belgium
facility: Pfizer Investigational Site
city: Wilrijk
country: Belgium
facility: Pfizer Investigational Site
city: Meldola
country: Italy
facility: Pfizer Investigational Site
state: FC
city: Milano
country: Italy
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Cardoso F, Canon JL, Amadori D, Aldrighetti D, Machiels JP, Bouko Y, Verkh L, Usari T, Kern KA, Giorgetti C, Dirix L. An exploratory study of sunitinib in combination with docetaxel and trastuzumab as first-line therapy for HER2-positive metastatic breast cancer. Breast. 2012 Dec;21(6):716-23. doi: 10.1016/j.breast.2012.09.002. Epub 2012 Sep 27.