Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer

NCT00656669

Last updated date
Study Location
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Females and Males
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

1. Patients must have histologically-confirmed adenocarcinoma of the breast with operable or inoperable stage 1c (primary tumor > 1.0 cm), II or III disease.

2. Measurable disease by physical examinations or diagnostic breast imaging (mammography, ultrasonography or MR).

3. Pre-treatment core or incisional biopsy. Patients may not have had definitive primary surgery.

4. Male or female, 18 years of age or older.

5. ECOG performance status 0 or 1.

6. Adequate organ function as defined in the protocol.

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


1. Prior radiation therapy, cytotoxic therapy or systemic therapy for breast cancer.
Prior use of tamoxifen or raloxifene as chemoprevention is allowed but must be
discontinued prior to study entry.


2. Metastatic (Stage IV) breast cancer


3. Patients who have had only a pre-treatment fine needle aspiration (FNA) are excluded.


4. Current therapeutic treatment on another clinical trial with an investigational agent.


5. Any of the following within the 6 months prior to starting study treatment:
-myocardial infarction -severe/unstable angina -coronary/peripheral artery bypass
graft -congestive heart failure -cerebrovascular accident including transient ischemic
attack -pulmonary embolus


6. Ongoing cardiac dysrhythmias of NCI CTCAE grade >=2, atrial fibrillation of any grade,
or QTc interval >450 msec for males or >470 msec for females.


7. Hypertension that cannot be controlled by medications.


8. Current treatment with therapeutic doses of any anti-coagulant. Prophylactic use of
anticoagulants is allowed.


9. Known human immunodeficiency virus (HIV) infection.


10. Pregnancy or breastfeeding. All female patients with reproductive potential must have
a negative pregnancy test prior to first day of study medication.


11. Other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that would impart, in the judgment of the investigator, excess risk
associated with study participation or study drug administration, or which, in the
judgment of the investigator, would make the patient inappropriate for entry into this
study.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer
Official Title  ICMJE An Exploratory Study of the Biological and Clinical Activity of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer
Brief Summary The combination of paclitaxel, doxorubicin, and cyclophosphamide is a standard neoadjuvant (given before surgery) treatment for patients that have either inoperable or operable breast cancer. This treatment can help shrink the tumors so they can be removed to help prevent the cancer from spreading to other parts of the body. This study is being done to test the impact of adding sunitinib as a single-agent (Segment 1), followed by sunitinib plus paclitaxel (Segment 2), followed by doxorubicin and cyclophosphamide (Segment 3). We hope the addition of sunitinib will make the treatment more effective, but we don't know if this is true.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: sunitinib alone
    sunitinib alone (segment 1): During the first segment, patients will receive single-agent sunitinib for 2 weeks.
  • Drug: sunitinib plus paclitaxel
    sunitinib plus paclitaxel (Segment 2): Following Segment 1, patients will begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel.
  • Drug: doxorubicin and cyclophosphamide
    doxorubicin and cyclophosphamide (Segment 3): Following Segment 2, patients will receive 4 cycles (8 weeks) of neoadjuvant treatment with AC.
Study Arms  ICMJE Experimental: 1
The study will be conducted in 3 sequential treatment segments.
Interventions:
  • Drug: sunitinib alone
  • Drug: sunitinib plus paclitaxel
  • Drug: doxorubicin and cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2012)
23
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2008)
30
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients must have histologically-confirmed adenocarcinoma of the breast with operable or inoperable stage 1c (primary tumor > 1.0 cm), II or III disease.
  2. Measurable disease by physical examinations or diagnostic breast imaging (mammography, ultrasonography or MR).
  3. Pre-treatment core or incisional biopsy. Patients may not have had definitive primary surgery.
  4. Male or female, 18 years of age or older.
  5. ECOG performance status 0 or 1.
  6. Adequate organ function as defined in the protocol.

Exclusion Criteria:

  1. Prior radiation therapy, cytotoxic therapy or systemic therapy for breast cancer. Prior use of tamoxifen or raloxifene as chemoprevention is allowed but must be discontinued prior to study entry.
  2. Metastatic (Stage IV) breast cancer
  3. Patients who have had only a pre-treatment fine needle aspiration (FNA) are excluded.
  4. Current therapeutic treatment on another clinical trial with an investigational agent.
  5. Any of the following within the 6 months prior to starting study treatment: -myocardial infarction -severe/unstable angina -coronary/peripheral artery bypass graft -congestive heart failure -cerebrovascular accident including transient ischemic attack -pulmonary embolus
  6. Ongoing cardiac dysrhythmias of NCI CTCAE grade >=2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.
  7. Hypertension that cannot be controlled by medications.
  8. Current treatment with therapeutic doses of any anti-coagulant. Prophylactic use of anticoagulants is allowed.
  9. Known human immunodeficiency virus (HIV) infection.
  10. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test prior to first day of study medication.
  11. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00656669
Other Study ID Numbers  ICMJE 0802-15/1011003564; IUCRO-0215
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Kathy Miller, MDIndiana University School of Medicine
PRS Account Indiana University
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP