We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00471159
Recruitment Status : Withdrawn
First Posted : May 9, 2007
Last Update Posted : May 4, 2015
Sponsor:
Information provided by:

Study Description
Brief Summary:
To assess the efficacy and safety of PF-3512676 administered in combination with docetaxel for the treatment of patients with advanced breast cancer.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: docetaxel Drug: PF-3512676 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Clinical Trial Of Docetaxel With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Breast Cancer
Study Start Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Progression-free survival
  2. Tumor assessment every 6 weeks until disease progression

Secondary Outcome Measures :
  1. Overall objective response rate, duration of response, time to tumor progression - tumor assessment every 6 weeks until disease progression
  2. Overall Survival - Patients will be followed for survival
  3. Overall safety profile -Targeted questions to patients throughout study, Weekly blood sampling during treatment, every 3 weeks during follow-up, Urine sample every 3 weeks during treatment and follow-up
  4. Changes in pain symptoms -Brief Pain Inventory questionnaire every 3 weeks during chemotherapy

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients with confirmed advanced breast cancer.
  • Patients with HER-2 negative disease with documented disease progression after (neo)adjuvant treatment with an anthracycline-based chemotherapy regimen.
  • Patients with adequate general well-being, kidney and liver function.

Exclusion Criteria:

  • Patients that have any condition that could affect patients safety, interfere with trial results, or makes the patient inappropriate for inclusion into study.
  • Patients who have had prior chemotherapy for advanced breast cancer.
  • Patients of child-bearing potential who are unwilling to use contraception.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471159


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00471159     History of Changes
Other Study ID Numbers: A8501007
First Posted: May 9, 2007    Key Record Dates
Last Update Posted: May 4, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action