Sunitinib Malate and Exemestane in Treating Postmenopausal Women With Breast Cancer

NCT00931450 | Unknown Phase 1

• 3 other identifiers: ICO-SUT-EXE-08CDR0000640330PFIZER-ICO-SUT-EXE-08
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sunitinib malate and exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving sunitinib malate and exemestane before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of sunitinib malate to see how well it works when given together with exemestane in treating postmenopausal women with breast cancer.

Conditions

Breast Cancer

Keywords

estrogen receptor-positive breast cancer; HER2-negative breast cancer; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer

Outcome Measures

Primary Outcomes (2)

• Recommended dose of sunitinib malate that can be combined with exemestane

• Objective clinical response (complete or partial response) according to WHO criteria

Secondary Outcomes (7)

• Safety and feasibility of the combination of sunitinib malate and exemestane

• Safety profile

• Rate of breast-conserving surgery

• Percentage of pathological complete response in the breast and axillary lymph nodes

• Grade of inhibition of phosphorylation of VEGFR-2, PDGF, and c-KIT receptor tyrosine kinases

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Patients receive oral exemestane and oral placebo once daily on days 1-28. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: exemestane; Other: placebo

Group 2

EXPERIMENTAL

Patients receive oral exemestane once daily and oral sunitinib malate once daily on days 1-28. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: exemestane; Drug: sunitinib malate

Interventions

exemestane DRUG

Given orally

Group 1; Group 2

sunitinib malate DRUG

Given orally

Group 2

placebo OTHER

Given orally

Group 1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast carcinoma meeting the following criteria: * Estrogen receptor-positive ≥ 50% or Allred score \> 6 * HER-2 negative defined as IHC \< 2+ and negative FISH/CISH * Primary tumor measuring ≥ 3 cm if there is no node involvement * Any T if N1 or N2 disease * No inflammatory breast cancer (T4d) * No metastatic disease * Measurable disease by mammography and/or ultrasound and MRI (if available) PATIENT CHARACTERISTICS: * Postmenopausal * Prior bilateral oophorectomy * ≥ 60 years of age * \< 60 years of age AND have experienced amenorrhea for ≥ 12 months in the absence of chemotherapy, tamoxifen, or toremifene OR have undergone ovarian suppression and follicle-stimulating hormone and estradiol levels in the postmenopausal range * ECOG performance status 0-1 * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min * Bilirubin normal * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Albumin \> 2.5. g/dL * No known HIV infection * Adequate left ventricular ejection fraction (LVEF) at baseline defined as LVEF not below normal range by echocardiogram or MUGA * No evidence of prior uncontrolled hypertension * Patients with controlled hypertension (systolic \< 150 mm Hg and/or diastolic \< 90 mm Hg) by antihypertensive therapies allowed * No prior uncontrolled or symptomatic angina, myocardial infarction, congestive heart failure, clinically significant arrhythmias, or prolongation of the QTc interval * No hemorrhagic or thrombotic events, including transient ischemic attack, pulmonary embolism, or deep-vein thrombosis, within the past 12 months * No gross hemorrhage within the past 6 months (e.g., gastrointestinal bleeding, hemoptysis, or hematuria) * No history or evidence of an inherited bleeding diathesis or coagulopathy at risk of bleeding * None of the following: * Unable to swallow oral medications * Active inflammatory bowel disease * Partial or complete bowel obstruction * Chronic diarrhea * No history of another malignancy within the past 5 years except for cured non-melanoma skin cancer or successfully treated carcinoma in situ of the cervix * No psychiatric disease or social situations that would limit compliance with study requirements or patient unwilling or unable to comply with protocol for the duration of study * No unstable or severe intercurrent medical condition that, in the opinion of the investigator, might interfere with the achievement of study objectives * No known immediate or delayed hypersensitive reaction or idiosyncrasy to drugs chemically related to exemestane or sunitinib malate or their excipients PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior or other concurrent chemotherapy, radiotherapy, immunotherapy, biologic therapy, or hormonal therapy for primary invasive breast cancer * No concurrent anticoagulant therapy except for low-dose anticoagulants (i.e., low molecular weight heparin or aspirin) for the prevention of deep-vein thrombosis * No chronic therapy with corticosteroids, except for steroids administered by inhalation * More than 4 weeks since prior major surgery and ≥ 7 days since prior minor surgery * No prior or other concurrent investigational anticancer agent * No concurrent participation in another clinical trial * No concurrent drugs with potential proarrhythmic activity * No concurrent known CYP3A4 inhibitors (i.e., grapefruit, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, clarithromycin, diltiazem, nefazodone, voriconazole, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, delavirdine) * No concurrent known CYP3A4 or CYP1A2 inducers (i.e., carbamazepine, dexamethasone, felbamate, omeprazole, efavirenz, tipranavir, phenobarbital, phenytoin, primidone, rifabutin, rifampicin, St. John's wort)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut Català d'Oncologia: lead

Study Sites (1)

Institut Catala D'Oncologia

L'Hospitalet de Llobregat, 08907, Spain

RECRUITING

Related Publications (1)

• Fullana B, Morales S, Petit A, Alay A, Verdaguer H, Climent F, Navarro-Perez V, Cejuela M, Galvan P, Guma A, Llombart-Cussac A, Cordero D, Casanovas O, Prat A, Gil-Gil M, Pernas S. Neoadjuvant sunitinib plus exemestane in post-menopausal women with hormone receptor-positive/HER2-negative early-stage breast cancer (SUT_EXE-08): a phase I/II trial. Sci Rep. 2024 Oct 9;14(1):23626. doi: 10.1038/s41598-024-72152-1.

  PMID: 39384801 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane; Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sonia Pernas, MD

  Institut Català d'Oncologia

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 2, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2011
• Last Updated: August 12, 2013

Record last verified: 2009-07

Locations

ES (1)