Phase 2
Completed N=68
Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer
Inflammatory Breast Cancer · male breast cancer · Stage II Breast Cancer · Stage IIIA Breast Cancer
Source: ClinicalTrials.gov NCT00513695 ↗
Enrolled (actual)
68
Serious AEs
69.1%
Results posted
May 2017
Primary outcomePrimary: Microscopic Pathologic CR (pCR) Rate — 27 percent of evaluable participants
Summary
This phase II trial studies how well giving sunitinib malate together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide before surgery works in treating patients with stage IIB-IIIC breast cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib malate together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Microscopic Pathologic CR (pCR) Rate |
27 | — |
| SECONDARY Clinical Complete Response and Correlation With Plasma VEGF, Soluble VCAM (sVCAM), and Circulating Endothelial Cells (CECs) Levels |
— | — |
| SECONDARY Relapse Rate |
0.215 | — |
| SECONDARY Time to Disease Progression |
NA | — |
| SECONDARY Overall Survival |
0.875 | — |
| SECONDARY Number and Percent of Subjects Reporting Adverse Events |
67 | — |
Eligibility Criteria
Inclusion Criteria
- Be informed of the investigational nature of the study and all pertinent aspects of the trial and must sign and give written consent in accordance with institutional and federal guidelines
- Have a histologically-confirmed diagnosis of breast cancer that is locally advanced or inflammatory; inflammatory breast cancer is defined as erythema and peau d'orange involving half or more of the breast with a histologic diagnosis of breast cancer; the finding of focal dermal lymphatic involvement on histology does not constitute inflammatory breast cancer
- Have selected stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0 or T0-2, N2, M0) disease judged primarily unresectable by an experienced breast surgeon or otherwise deemed appropriate candidates for neoadjuvant treatment or stage IIIB (T4, any N, M0) or stage IIIC (any T, N3, M0) disease
- Patients must have a performance status of 0-2 by Zubrod criteria
- Absolute neutrophil count (ANC) >= 1, 500 cells/mm^3
- Platelet count >= 100,000 cells/mm^3
- Serum creatinine = = 2
- Have uncontrolled hypertension (>150/100 mm Hg despite optimal medical therapy)
- Have pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- Have a known, active infection
- Have any prior malignancy except for adequately treated basal cell or squamous cell skin cancer, any in situ cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission or any other cancer from which the patient has been disease-free for 5 years
- Human immunodeficiency virus (HIV) positive
- Are receiving or planning to receive any concurrent anticancer therapy while receiving protocol treatment
- Are receiving or planning to receive concurrent treatment on another clinical trial (supportive care trials or non-treatment trials, e.g. quality of life (QOL) are allowed; participation in the companion imaging trial, dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) and fludeoxyglucose F 18 positron emission tomography (FDG PET) with Kinetic Analysis to Monitor Breast Cancer Response to Neoadjuvant Sunitinib and Metronomic Chemotherapy is also allowed)
- Be pregnant or breast feeding; female subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy; all female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment; male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy; the definition of effective contraception will be based on the judgment of the principal investigator or a designated associate
- Have other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study
Data sourced from ClinicalTrials.gov (NCT00513695). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.