CTRI/2014/03/004443进行中（未招募）3 期
A phase IIIb, multi-center, open-label, expanded access study of EVERolimus (RAD001)in combination with EXemestane in post-menopausal women with EStrogen receptor positive, human epidermal growth factor receptor 2 negative locally advanced or metastatic breast cancer - EVEREXES
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Adult women (greater than or equal to 18 years of age) with metastatic, recurrent or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
- •2. Histological or cytological confirmation of estrogen receptor positive (ER positive) breast cancer.
- •3. Postmenopausal women. Ovarian radiation or treatment with a luteinizing hormonereleasing
- •hormone (LHRH) agonist (goserelin acetate or leuprolide acetate) does not
- •satisfy this inclusion criterion. Postmenopausal status is defined by one of the following:
- •Age greater than or equal to 55 years and one year or more of amenorrhea
- •Age greater than 55 years and one year or more of amenorrhea, with estradiol assay less than 20 pg per ml
- •and/or post-menopausal levels of FSH and LH per local institutional standards
- •Prior hysterectomy, with estradiol assay less than 20 pg per ml and/or post-menopausal levels of
- •FSH and LH per local institutional standards
- •Surgical menopause with bilateral oophorectomy.
- •4. Disease refractory to non-steroidal aromatase inhibitors (NSAI), defined as:
- •Recurrence while on, or within 12 months (365 days) of completion of adjuvant
- •therapy with letrozole or anastrozole,
- •Progression while on, or within one month (30 days) of completion of letrozole or
- •anastrozole treatment for ABC.
- •Notes: Letrozole or anastrozole do not have to be the last treatment prior to study
- •baseline. Patients may have received one prior chemotherapy line for ABC, or
- •have received other endocrine treatments such as tamoxifen, or fulvestrant.
- •5. Radiological or objective evidence of recurrence or progression on or after the last
- •systemic therapy prior to enrolment.
- •Notes: The last line of therapy may be any other treatment than exemestane and
- •mTOR inhibitors. Patients must have recovered to grade 1 or better from any adverse
- •events related to previous therapy (except alopecia) prior to enrolment.
- •6. Patients must have:
- •Measurable disease defined as at least one lesion that can be accurately measured in
- •at least one dimension greater than or equal to 20 mm with conventional imaging techniques or greater than or equal to 10 mm
- •with spiral CT or MRI,
- •Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as
- •defined above.
- •Note: Lymph nodes must be greater than or equal to 15 mm in the short axis to be considered measurable
- •Patients with bone lesions and at least one measurable lesion are considered as having
- •measurable disease
- •If bone lesions have been previously irradiated, at least one lesion must have clearly
- •progressed since the radiotherapy by CT, MRI or X-ray for trial entry (in the absence
- •of measurable disease).
- •7. Adequate bone marrow and coagulation function as shown by:
- •Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10 raised to 9 per L
- •Platelets greater than or equal to 100 Ã? 10 raised to 9 per L
- •Hemoglobin (Hgb) greater than or equal to 9.0 g per dL
- •INR less than or equal to 2.
- •8. Adequate liver function as shown by:
- •Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5
- •ULN (or less than or equ
排除标准
- •1. Patients overexpressing HER2 by local laboratory testing (IHC 3 positive staining or in situ
- •hybridization positive), based on the most recent test. Patients with IHC 2 positive must have a
- •negative in situ hybridization test.
- •2. Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion,
- •3. Patients with more than one prior chemotherapy line for treating metastatic breast cancer.
- •A chemotherapy line is an anticancer regimen(s) that contains at least 1 cytotoxic
- •chemotherapy agent, given for a minimum of 21 days. A cytotoxic chemotherapy regimen
- •that lasted less than 21 days and was discontinued for a reason other than disease
- •progression is not accounted as a prior line of chemotherapy.
- •4. Previous treatment with exemestane or mTOR inhibitors.
- •5. Known hypersensitivity to mTOR inhibitors, e.g. Sirolimus (rapamycin).
- •6. Any other malignancy within 5 years prior to enrolment, with the exception of adequately
- •treated in-situ carcinoma of the cervix uteri, basal or squamous skin cell carcinoma, or
- •non-melanoma skin cancer.
- •7. Radiotherapy within four weeks prior to enrolment, except radiotherapy to the bone for
- •analgesic purpose or for lytic lesions at risk of fracture. Patients must have recovered from
- •radiotherapy toxicities prior to enrolment.
- •8. Patient receiving hormone replacement therapy (HRT). Patient may be enrolled after
- •discontinuation of HRT.
- •9. History of brain or other CNS metastases.
- •10. Treatment with immunosuppressive agents or chronic corticosteroids, with the following
- •exceptions:
- •Patients on stable low dose of systemic corticosteroids for at least two weeks before
- •Corticosteroids used in topical applications (e.g. cream), inhaled sprays, eye drops or
- •local (e.g. intra-articular) injections.
- •11. Bilateral diffuse lymphangitic carcinomatosis.
- •12. Patients with a known history of HIV seropositivity. Screening for HIV infection at
- •baseline is not required.
- •13. Active, bleeding diathesis. Patients treated with anti-vitamin K medication, LMWH, or
- •anti-platelet medication must have an INR <= 2.0.
- •14. Any severe and / or uncontrolled medical conditions such as:
- •a. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction
- •less than or equal to 6 months prior to enrolment, serious uncontrolled cardiac arrhythmia
- •b. Uncontrolled diabetes as defined by fasting serum glucose more than 1.5 times ULN
- •c. Acute and chronic, active infectious disorders (except for Hep B and Hep C positive
- •patients) and non-malignant medical illnesses that are uncontrolled or whose control
- •may be jeopardized by the complications of this study therapy
- •d. Impairment of gastrointestinal function or who have gastrointestinal disease that may
- •significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled
- •nausea, vomiting, diarrhea, malabsorption syndrome)
- •e. Active skin, mucosa, ocular or gastro-intestinal disorders of Grade greater than 1
- •f. Significant symptomatic deterioration of lung function. If clinically indicated,
- •pulmonary function tests including measures of predicted lung volumes, DLco, O2
- •saturation at rest on room air
研究者
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