EUCTR2007-005209-23-ES进行中（未招募）1 期
Randomized Phase II of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects with Triple Negative (ER, PR, Her2 negative) Locally Advanced non-resectable and/or Metastatic Breast CancerEstudio fase II aleatorizado de ixabepilona o ixabepilona más cetuximab como tratamiento de primera línea en mujeres con cáncer de mama localmente avanzado no rescable y/o metastásico triple negativo (negativo para RE, RP y HER2)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •1) Signed Written Informed Consent
- •2) Target Population
- •a) Histologic or cytologic confirmed diagnosis of invasive adenocarcinoma
- •originating in the breast with evidence of locally advanced non-resectable and/or
- •metastatic disease.
- •b) At least one target lesion per RECIST criteria.
- •c) Previously radiated area(s) must not be the only site of disease.
- •d) Subjects must have breast cancer not overexpressing or amplify Her2:
- •IHC 0 and 1+ tumors are allowed into the study unless FISH is positive.
- •IHC 2+ tumors are allowed into the study only if FISH is negative. Her2 status will be determined based on local measurements that have been done at diagnosis (based on the primary tumor), or based on re-biopsy. Measurements of the primary tumor will not be considered if a valid measurement of the metastasis is available.
- •e) Subjects must have breast cancer that does not express any hormone receptors
- •(ER and/or PR). Hormone receptor status will be determined based on local measurements that have been done at diagnosis (based on the primary tumor), or
- •based on re-biopsy. Measurements of the primary tumor will not be considered if a valid measurement of the metastasis is available.
- •f) Subjects must have had prior adjuvant or neoadjuvant anthracycline-based chemotherapy
- •g) Prior endocrine therapy in (neo)adjuvant, recurrent or metastatic setting is allowed, but this must have been discontinued at least 2 weeks prior to
- •randomization.
- •h) Karnofsky Performance Status (PS) of 80-100 (or Eastern Cooperative Oncology Group, PS of 0-1) (See Protocol Appendix 3).
- •i) Estimated life expectancy of at least 12 weeks.
- •j) Recovery (except for alopecia, fatigue and grade 1 neuropathy) from recent
- •therapy, including chemotherapy, immunotherapy, biological therapy or investigational product. Any such therapy must have been completed at least 3
- •weeks prior to randomization.
- •k) Recovery from recent surgery; at least one week must have elapsed from minor surgery (e.g. placement of venous access device or fine needle aspiration), at least
- •4 weeks from major surgery.
- •l) Recovery from radiation; at least one week from focal/palliative radiation therapy and 3 weeks from any therapeutic radiation.
- •m) Accessible for treatment and follow-up. Subjects enrolled in this trial must be treated at the participating center
- •3) Age and Sex
- •a) Women 18 years of age or older. Male subjects will be excluded from this trial. Due to the small size population of this trial the expected number of male subjects enrolled would be such that no clinically significant information would be
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Sex and Reproductive Status
- •a) WOCBP who are unwilling or unable to use an acceptable method to avoid
- •pregnancy for the entire study and for up to 12 weeks after the last dose of any study drug.
- •b) Women who are pregnant or breastfeeding
- •c) Women with a positive pregnancy test on enrollment or prior to investigational product administration.
- •2) Target Disease Exceptions
- •a) Evidence of baseline sensory or motor neuropathy > Grade 1.
- •b) Any current or previous history of brain and/or leptomeningeal metastases
- •including evidence of cerebral edema by computerized tomography (CT) or
- •magnetic resonance.
- •c) Prior radiation must not have included = 30% of major bone marrow containing
- •areas (pelvis, lumbar spine).
- •d) Subjects who have received prior systemic therapy for metastatic disease.
- •e) Tumors excluded from the study are the ones that are FISH positive or IHC 3+.
- •3) Medical History and Concurrent Diseases
- •a) Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled or the control of which may be jeopardized by this therapy.
- •b) Any concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix. Subjects with a history of previous malignancies but without evidence of disease for = 5 years will be allowed to enter the trial.
- •c) Clinically significant cardiovascular disease (e.g. unstable angina, congestive heart failure, myocardial infarction) within 6 months prior to study entry.
- •d) Prior history of high dose chemotherapy with bone marrow transplant or
- •peripheral blood stem cell transplant within the previous 2 years.
- •e) Prior treatment with an epothilone (or epothilone analogue) or an EGFR inhibitor.
- •4) Physical and Laboratory Test Findings
- •a) Absolute Neutrophil Count (ANC) = 1500/mm³,
- •b) Hemoglobin = 9 g/dL,
- •c) Platelets < 100,000/mm³
- •d) Total bilirubin > 1.0x times the upper limit of normal (ULN)
- •e) AST or ALT = 2.5 x ULN.
- •5) Allergies and Adverse Drug Reactions
- •a) Known allergy to any of the study drugs or their excipients such as, prior severe Hypersensitivity Reaction (HSR) to agents containing Cremophor®EL; or allergies to Chinese hamster ovary cell proteins or other recombinant humanized antibodies.
- •i) Prior Grade 1 or 2 hypersensitivity reaction to taxane therapies allowed
- •provided drug administration was possible.
- •6) Prohibited Treatments and/or Therapies
- •a) Subjects must not continue or institute treatment with strong inhibitors of
- •CYP3A4 from 72 hours prior to the initiation of study therapy until end of
- •treatment with ixabepilone (e.g., ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine, or voriconazole).
- •b) Other concurrent anti-tumor chemotherapy, hormonal therapy, immunotherapy regimens or radiation therapy, standard or investigational.
- •7) Other Exclusion Criteria
- •a) Prisoners or subjects who are involuntarily incarcerated
- •b) Subjects who are compulsorily detained for treatment of either a psychiatric or
- •physical (eg, infectious disease) illness
研究者
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