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Phase 1/2 Open-Label Trial Of Sutent (Sunitinib Malate) And Aromasin(Exemestane) In The First-Line Treatment Of Hormone Receptor-Positive Metastatic Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

Phase 1/2 Open-Label Trial Of Sutent (Sunitinib Malate) And Aromasin(Exemestane) In The First-Line Treatment Of Hormone Receptor-Positive Metastatic Breast Cancer


The trial was terminated prematurely on August 28, 2008 due to the inability to recruit the
planned number of subjects in order to provide meaningful efficacy data. There were no
safety concerns regarding the study in the decision to terminate the trial.


Inclusion Criteria:



- 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]
- Evaluable(e.g bone only disease allowed) and Measurable disease [RECIST (Response
Evaluation Criterion in Solid Tumors)]

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181108

NCT ID:

NCT00417885

Start Date:

June 2007

Completion Date:

July 2009

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

Name

Location

Pfizer Investigational SiteAtlanta, Georgia  30342