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Neoadjuvant Sunitinib With Paclitaxel/Carboplatin in Patients With Triple-Negative Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Neoadjuvant Sunitinib With Paclitaxel/Carboplatin in Patients With Triple-Negative Breast Cancer

Phase I/II Trial of Neoadjuvant Sunitinib Administered With Weekly Paclitaxel/Carboplatin in Patients With Locally Advanced Triple-Negative Breast Cancer

NCT00887575•SCRI Development Innovations, LLC

View on ClinicalTrials.gov

Summary

This trial will examine the combination of sunitinib plus paclitaxel and carboplatin as neoadjuvant treatment for locally advanced breast cancer.

Detailed Description

This open label, Phase I/II trial is designed to evaluate the combination of sunitinib plus paclitaxel and carboplatin as neoadjuvant treatment for locally advanced breast cancer. The Phase I portion of this study will determine the maximum tolerated dose (MTD) of paclitaxel, sunitinib and carboplatin that can be used together as neoadjuvant treatment in patients with locally advanced breast cancer. The MTD identified in the Phase I portion of the study will be used in the Phase II portion which will evaluate the efficacy, safety, and tolerability of neoadjuvant sunitinib/paclitaxel/carboplatin given for 6 cycles in patients with locally advanced breast cancer.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Female patients, age ≥18 years
•2. Histologically confirmed invasive ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma of the breast
•3. Triple-negative tumors are defined as:
•* For HER2-negative:
•* Fluorescence in situ hybridization (FISH)-negative (defined by ratio \<2.2) OR
•* Immunohistochemical (IHC) 0, IHC 1+, OR
•* IHC 2+ or IHC 3+ and FISH-negative (defined by ratio \<2.2)
•* For ER- and PR-negative: \<10% tumor staining by immunohistochemistry (IHC)
•4. Primary palpable disease confined to a breast and axilla on physical examination. For patients without clinically suspicious axillary adenopathy, the primary tumor must be larger than 2 cm in diameter by physical exam or imaging studies (clinical T2-T3, N0-N1, M0). For patients with clinically suspicious axillary adenopathy, the primary breast tumor can be any size (clinical T1-3, N1-2, M0). T1N0M0 lesions are excluded. Patients with metastatic disease are excluded.
•5. Patients without clearly defined palpable breast mass or axillary lymph nodes but radiographically measurable tumor masses are eligible. Accepted procedures for measuring breast disease are mammography, MRI, and breast ultrasound. Patients with lesions measurable only by imaging will require repeat imaging after 3 cycles and prior to surgery
+19 more criteria

Exclusion Criteria

•1. Previous treatment for this breast cancer
•2. Previous treatment with paclitaxel or carboplatin
•3. Previous treatment with sunitinib or other angiogenic inhibitors (including, but not limited to bevacizumab, sorafenib, thalidomide)
•4. Any of the following within the 12 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, or pulmonary embolus
•5. Uncontrolled hypertension (blood pressure \>150/100 mmHg despite optimal medical therapy)
•6. Ongoing cardiac dysrhythmias grade ≥2, atrial fibrillation of any grade, or prolongation of the QTc interval to \>470 msec
•7. Major surgery, significant traumatic injury, or radiation therapy within 4 weeks of starting study treatment. An interval of at least 1week is required following minor surgical procedures, with the exception of placement of a vascular access device
•8. Grade 3 hemorrhage within 4 weeks of starting study treatment
•9. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
•10. Known human immunodeficiency virus (HIV) infection or other serious infection
+5 more criteria

Locations (14)

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Florida Cancer Specialists North

Fort Myers, Florida, United States

Florida Cancer Specialists South

Fort Myers, Florida, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Providence Medical Group

Terre Haute, Indiana, United States

Baptist Hospital East

Louisville, Kentucky, United States

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

National Capital Clinical Research Consortium

Bethesda, Maryland, United States

St. Louis Cancer Care

Chesterfield, Missouri, United States

Nebraska Methodist Cancer Center

Omaha, Nebraska, United States

Key Dates

Start Date

June 1, 2009

Primary Completion Date

July 1, 2013

Completion Date

September 1, 2014

Last Updated

September 7, 2016

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

Paclitaxel

DRUG

Carboplatin

DRUG

Sunitinib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 7, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Neoadjuvant Sunitinib With Paclitaxel/Carboplatin in Patients With Triple-Negative Breast Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer