EUCTR2011-005219-98-HU进行中（未招募）1 期
Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment (PRESENT) - PRESENT
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Inclusion Criteria to be Eligible for HLA Typing (First Qualification Visit)
- •1. Women, at least 18 years of age.
- •2. Pathological diagnosis of invasive adenocarcinoma of the breast.
- •3. Breast cancer completely excised.
- •4. One of these 2 surgical treatments:
- •-Total mastectomy and axillary staging with sentinel lymph node dissection or axillary dissection level I/II. Patients with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II.
- •-BCS (lumpectomy) and axillary staging with sentinel lymph node dissection or
- •axillary dissection level I/II. Patients with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II unless they had clinically node negative T1-T2 tumors and fewer than 3 involved lymph nodes.
- •5. Node-positive disease:
- •- Confirmed histologically (hemotoxylin/eosin [H/E] staining or IHC staining) by pathological examination of sentinel lymph nodes and follow-on axillary node dissection (when indicated), or both.
- •- Pathologic pN1 (including pN1mi) or pN2 disease.
- •6. Primary tumor stage T1-3. Ipsilateral nodes must be N0-1 by clinical evaluation and pN1 M0 or pN2 M0
- •7. Tumor tissue availability - HER2-positive disease to be reconfirmed by IHC staining:
- •- 1+ or 2+ intensity (if 2+ by IHC, HER2 gene amplification to be confirmed by FISH showing HER2/CEP 17 ratio of 2.2 or less, or negative) by a qualified central clinical laboratory.
- •8. Hormone receptor (ER/PR) status determined by qualified laboratory.
- •9. Must complete approved regimen of neoadjuvant or adjuvant chemotherapy, or both, consisting of at least 4 cycles before receiving study treatment (and subjects must have recovered (toxicity recovered to = Grade 1) from effect of recent surgery, radiotherapy, or adjuvant chemotherapy as determined by the
- •principal investigator).
- •10. Must not be more than 2 months ± 7 days (and no sooner than 1 month) from completion of last adjuvant chemo- or radiotherapy, at the time of first study treatment.
- •11. Must complete approved radiation therapy for subjects with total mastectomy prior to receiving study treatment:
- •- 1-3 positive axillary nodes – chest wall irradiation and irradiation to the
- •infraclavicular and supraclavicular areas and to the internal mammary nodes is not mandatory but may be administered at the discretion of the treating radiation oncologist.
- •- = 4 <10 positive axillary nodes – chest wall irradiation and irradiation to the
- •infraclavicular and supraclavicular area are mandatory; Irradiation to the axillary area is not mandatory; irradiation of the internal mammary nodes is not mandatory.
- •12. Must complete approved radiation therapy for subjects with BCS prior to receiving study treatment: Adjuvant breast radiation is indicated for all subjects treated with breast conservation (whole breast irradiation with or without boost” dose of radiation to the tumor bed):
- •- 1 to 3 positive axillary nodes: irradiation to the supraclavicular area is not mandatory; irradiation to the axillary area is not mandatory; irradiation of the internal mammary nodes is not mandatory.
- •- = 4 <10 positive axillary: irradiation to the infraclavicular and supraclavicular areas is mandatory; irradiation to the axillary area is not mandatory; and irradiation of the internal mammary nodes is not mandatory.
- •13. Subjects with hormone-receptor–positive disease must have adjuvant endocrine therapy after chemotherapy (unless contraindicated).
排除标准
- •1. Under 18 years of age.
- •2. Bilateral breast malignancy.
- •3. Inflammatory breast cancer.
- •4. Unconfirmed, nonmalignant but suspicious mass in opposite breast.
- •5. Primary tumor stage T4.
- •6. Nodes: clinical N2 or N3 or pathologic pN3.
- •7. History of prior breast cancer.
- •8. History of prior ductal carcinoma in situ (DCIS). Prior lobular carcinoma in situ (LCIS) is allowed.
- •9. Prior trastuzumab therapy.
- •10. Except for adjuvant endocrine therapy, tamoxifen and aromatase inhibitors (i.e., anastrozole, exemestane and letrozole) or LHRH agonists (i.e., goselerlin, leuprolide), unwilling to stop current hormonal therapies of raloxifene or other selective estrogen receptor modulators (i.e., afimoxifene, arzoxifene, bazedoxifene, clomifene, femarelle, lasofoxifene, ormeloxifene, and toremifene) at least 1 month before randomization.
- •11. New York Heart Association Stage 3 or 4 cardiac disease
- •12. Pregnant or breastfeeding.
- •13. Sensory/motor neuropathy = Grade 2.
- •14. Autoimmune diseases including rheumatoid arthritis, lupus erythematosus, type 1 diabetes mellitus or any other autoimmune disease that, in the opinion of the investigator, would compromise the subject’s safety.
- •15. Immune deficiency diseases such as immunoglobulin deficiency or immunosuppressive therapy that might interfere with appropriate immune response
- •16. Positive test for human immunodeficiency virus (HIV), or hepatitis B or C.
- •17. Patients on chronic steroid therapy or other immunosuppressive therapy except for topical steroids.
- •18. Patients with a known hypersensitivity to GM-CSF, yeast-derived products, or any component of the GM-CSF product (e.g. mannitol).
- •19. Concurrent treatment with other investigational agents.
- •20. Nonbreast malignancy within 5 years before randomization, except cured superficial recurrent bladder cancer, carcinoma in situ of the cervix (Stage 0 – 1), and basal cell or squamous cell carcinoma of the skin.
- •21. Nonmalignant systemic disease that, in the opinion of the investigator, should preclude the subject’s participation in the study.
研究者
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