Sutent Neoadjuvant Study | RxWiki

Sutent Neoadjuvant Study

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Breast Cancer
Intervention	Drug: sunitinib alone Drug: sunitinib plus paclitaxel Drug: doxorubicin and cyclophosphamide
Phase	N/A
Sponsor	Indiana University
Responsible Party	Indiana University
ClinicalTrials.gov Identifier	NCT00656669
First Received	April 7, 2008
Last Updated	July 12, 2013
Last verified	December 2012

Tracking Information[ + expand ][ + ]

First Received Date	April 7, 2008
Last Updated Date	July 12, 2013
Start Date	April 2008
Estimated Primary Completion Date	January 2014
Current Primary Outcome Measures	To measure changes in interstitial fluid pressure (IFP) induced by sunitinib monotherapy [Time Frame: screening through cycle 6] [Designated as safety issue: No]
Current Secondary Outcome Measures	To measure changes in interstitial fluid pressure (IFP) induced by paclitaxel plus sunitinib after sunitinib monotherapy [Time Frame: screening through cycle 6] [Designated as safety issue: No] To assess the pathological complete response (pCR) rate for patients treated with sunitinib/paclitaxel followed by AC as neoadjuvant therapy for breast cancer [Time Frame: screening through surgery] [Designated as safety issue: No] To evaluate the safety of paclitaxel plus sunitinib when given in combination as neoadjuvant therapy [Time Frame: screening through surgery] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Sutent Neoadjuvant Study
Official Title	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	Interventional
Study Phase	N/A
Study Design	Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Breast Cancer
Intervention	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 Arm (s)	Experimental: 1 The study will be conducted in 3 sequential treatment segments.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	23
Estimated Completion Date	January 2014
Estimated Primary Completion Date	September 2010
Eligibility Criteria	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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00656669
Other Study ID Numbers	0802-15/1011003564; IUCRO-0215
Has Data Monitoring Committee	Yes
Information Provided By	Indiana University
Study Sponsor	Indiana University
Collaborators	Pfizer
Investigators	Principal Investigator: Kathy Miller, MD Indiana University School of Medicine
Verification Date	December 2012

Locations[ + expand ][ + ]