NCT00417885

Brief Summary

To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent, unresectable breast cancer.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2007

Typical duration for phase_1

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 30, 2010

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

Enrollment Period

2.1 years

First QC Date

January 2, 2007

Results QC Date

July 9, 2010

Last Update Submit

September 16, 2010

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS)

    PFS was defined as the time from enrollment to first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was to be calculated as (first event date - the date of enrollment +1)/7.

    From start of treatment until Day 1 of every other cycle (8 weeks) or death

Secondary Outcomes (5)

  • Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)

    From start of treatment until Day 1 of every other cycle (8 weeks)

  • Duration of Response (DR)

    From start of treatment until Day 1 of every other cycle (8 weeks) or death due to cancer

  • Overall Survival (OS)

    From start of study treatment until death

  • Time to Tumor Progression (TTP)

    From start of treatment until Day 1 of every other cycle (8 weeks)

  • Clinical Benefit Rate (CBR)

    From start of treatment until Day 1 of every other cycle (8 weeks)

Study Arms (1)

A

EXPERIMENTAL

sunitinib + exemestane

Drug: exemestaneDrug: sunitinib malate

Interventions

exemestaneDRUG

25 mg, oral, daily dosing

A
sunitinib malateDRUG

37.5 mg, oral, continuous dosing, daily

Also known as: sutent
A

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • Estrogen and/or progesterone receptor positive adenocarcinoma of the breast with evidence of 1) unresectable 2)locally recurrent, or 3) metastatic disease
  • Postmenopausal
  • ECOG \[Eastern Cooperative Oncology Group\] \</=1
  • Evaluable(e.g bone only disease allowed) and Measurable disease \[RECIST (Response Evaluation Criterion in Solid Tumors)\]

You may not qualify if:

  • HER2 \[Human Epidermal Growth factor Receptor 2\] positive disease not previously treated with herceptin
  • Any prior anti-angiogenic therapy, endocrine or cytotoxic anti-cancer therapy in the metastatic disease setting
  • Radiation therapy within 2 weeks of first study treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Atlanta, Georgia, 30322, United States

Location

Pfizer Investigational Site

Montreal, Quebec, H3G 1A4, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3G 1L5, Canada

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestaneSunitinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 2, 2007

First Posted

January 4, 2007

Study Start

June 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

September 21, 2010

Results First Posted

August 30, 2010

Record last verified: 2010-09

Locations

CA(2)US(1)