Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Trastuzumab

Sunitinib

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Combination of SU011248 (37.5 mg once daily \[Schedule 2/1\]) with docetaxel (75 mg/m2 every 3 weeks) and trastuzumab (therapeutic dose)

Trastuzumab will be administered intravenously on Day 1 before docetaxel - loading dose of 4 mg/kg over 90-minute on Day 1 followed by weekly maintenance doses of 2 mg/kg on Days 1, 8, 15 given as 30-minute infusions if the initial loading dose was well tolerated. Loading dose of 8 mg/kg over 90-minute on Day 1 followed by 3-weekly maintenance doses of 6 mg/kg given as 90-minute infusions. The administration of 6 mg/kg will be repeated on Day 1 every 3 weeks.

Herceptin

SU011248 will be administered at 37.5 mg once daily for 2 weeks every 3 weeks (Schedule 2/1) starting from Day 2, when in combination with docetaxel. SU011248 will be administered at the starting dose of 37.5 mg daily in a continuous regimen when docetaxel is discontinued.

The starting dose of docetaxel will be 75 mg/m2 every 3 weeks, administered on Day 1 of each cycle as a 1-hour IV infusion.

Taxotere

Pfizer CT.gov Call Center

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.

Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive

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

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all target lesions. PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").

Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

Ctrough = the concentration prior to study medication administration. Ctrough was calculated for SU011248 (Sunitinib), SU012662 (Sunitinib metabolite) and total drug (SU011248+SU012662). Concentration values below the lower limit of quantification were taken as zero.

Concentration values below the lower limit of quantification were taken as zero.

Ctrough = the concentration prior to study medication administration.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m\^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.

Sunitinib + Docetaxel + Trastuzumab

Age Continuous

Sex: Female, Male

Pfizer ClinicalTrials.gov Call Center

SAEs

Safety population included all participants enrolled in the study who received at least 1 dose of study medication.

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Per protocol (PP) population included all participants who received at least 1 dose of sunitinib and had at least a tumor assessment post baseline.

Percentage of Participants With Objective Response (OR)

Study population included all participants who received at least 1 dose of study medication.

Progression-free Survival (PFS)

Study population, subgroup of participants with a confirmed objective tumor response (CR or PR).

Duration of Response (DR)

Sunitinib: Cycle1/Day15 (n= 19)

Sunitinib: Cycle2/Day1 (n= 17)

Sunitinib: Cycle2/Day15 (n= 16)

Sunitinib: Cycle4/Day1 (n= 17)

Sunitinib: Cycle4/Day15 (n= 16)

Sunitinib: Cycle6/Day1 (n= 16)

Sunitinib: Cycle6/Day15 (n= 13)

Sunitinib Metabolite: Cycle1/Day15 (n= 19)

Sunitinib Metabolite: Cycle2/Day1 (n= 17)

Sunitinib Metabolite: Cycle2/Day15 (n= 16)

Sunitinib Metabolite: Cycle4/Day1 (n= 17)

Sunitinib Metabolite: Cycle4/Day15 (n= 16)

Sunitinib Metabolite: Cycle6/Day1 (n= 16)

Sunitinib Metabolite: Cycle6/Day15 (n= 13)

Total Drug: Cycle1/Day15 (n= 19)

Total Drug: Cycle2/Day1 (n= 17)

Total Drug: Cycle2/Day15 (n= 16)

Total Drug: Cycle4/Day1 (n= 17)

Total Drug: Cycle4/Day15 (n= 16)

Total Drug: Cycle6/Day1 (n= 16)

Total Drug: Cycle6/Day15 (n= 13)

Pharmacokinetic (PK) analysis set included participants from study population who had completed sampling for pharmacokinetic profiles for study medication. 'n' is number of participants who were evaluable at given time points.

Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662)

Cycle1/Day1 (n= 23)

Cycle2/Day1 (n= 19)

Cycle4/Day1 (n= 16)

Cycle6/Day1 (n= 15)

PK analysis set included participants from study population who had completed sampling for pharmacokinetic profiles for study medication. 'n' is number of participants who were evaluable at given time points.

Maximum Observed Plasma Concentration (Cmax) of Docetaxel

Data was not summarized since majority of observed Ctrough values were below lower limit of quantification.

Plasma Trough Concentrations (Ctrough) of Trastuzumab

Data not analyzed since paclitaxel was not administered in the study.

Spots Global Cancer Trial Database for Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive

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