You are here

Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Berkely, California, 94704 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Breast cancer with evidence of unresectable locally recurrent, or metastatic disease

- Her-2 negative tumors

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients for whom docetaxel is contraindicated

- Clinical presentation of inflammatory carcinoma with no other measurable disease

NCT00393939
Pfizer
Completed
Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Her2(-) Breast Cancer ER/PR(+)
NCT02924584
All Genders
0+
Years
Tainan City,
Advanced Breast Cancer, Metastatic Breast Cancer
NCT03280303
All Genders
18+
Years
Multiple Sites
Breast Neoplasms, Stomach Neoplasms, Esophagogastric Junction Neoplasm, Non-small-cell Lung Carcinoma
NCT03284723
All Genders
18+
Years
Multiple Sites
Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer
A Randomized Phase 3 Study Of Docetaxel In Combination With Sunitinib Versus Docetaxel In The First-Line Treatment Of Advanced Breast Cancer Patients
This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
  • Drug: Sunitinib malate
    Sunitinib 37.5 mg daily by oral capsule in schedule 2/1 with Docetaxel 75 mg/m2 every 3 weeks or 37. 5 mg daily in continuous dosing (in absence of docetaxel)
  • Drug: Taxotere
    Docetaxel 100 mg/m2 every 3 weeks in the comparator arm
  • Experimental: A
    Intervention: Drug: Sunitinib malate
  • Active Comparator: B
    Intervention: Drug: Taxotere
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
594
July 2011
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Breast cancer with evidence of unresectable locally recurrent, or metastatic disease
  • Her-2 negative tumors

Exclusion Criteria:

  • Patients for whom docetaxel is contraindicated
  • Clinical presentation of inflammatory carcinoma with no other measurable disease
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belgium,   Canada,   Colombia,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Ireland,   Italy,   Korea, Republic of,   Netherlands,   Panama,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Turkey,   Ukraine,   United Kingdom,   United States
 
 
NCT00393939
A6181064
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now