Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00243503
• Date of registration: 20/10/2005
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer
• Scientific title: A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer
• Date of first enrolment: February 2006
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00243503
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, France, Spain, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or
2) metastatic disease.

- HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)

- Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/
lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted.
Treatment with hormone therapy in the adjuvant and/or advanced disease setting is
permitted.

Exclusion Criteria:

- Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting.
Adjuvant chemotherapy is permitted

- Prior exposure to trastuzumab if the patient had developed severe hypersensitivity
reactions.

- Prior treatment on a SU11248 clinical trial.

- Uncontrolled brain metastases.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Breast Neoplasms

Intervention(s)

Drug: SU011248/Trastuzumab

Primary Outcome(s)

Percentage of Participants With Overall Confirmed Objective Disease Response [Time Frame: From start of treatment through 18 months]

Secondary Outcome(s)

Time to Progression (TTP) [Time Frame: From start of treatment through 18 months]

Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite) [Time Frame: Predose on Day 1 of Cycle 3 and 5]

EORTC QLQ (BR23) [Time Frame: From start of treatment through 18 months]

Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib [Time Frame: Predose on Day 1 of Cycle 3 and 5]

Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662) [Time Frame: Predose on Day 1 of Cycle 3 and 5]

Percentage of Participants With Clinical Benefit [Time Frame: From start of treatment through 18 months]

Overall Survival (OS) [Time Frame: From start of study treatment until death or 2 years from first study treatment]

EORTC QLQ-C30 [Time Frame: From start of treatment through 18 months]

Duration of Response (DR) [Time Frame: From start of treatment through 18 months]

Probability of Survival at One Year [Time Frame: From start of study treatment until death or 2 years from first study treatment]

Progression Free Survival (PFS) [Time Frame: From start of treatment through 18 months]

Secondary ID(s)

A6181067

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/05/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00243503