EUCTR2011-003044-53-SE进行中（未招募）不适用
AN OPEN-LABEL, RANDOMISED PHASE 1B/2 STUDY OF PF-04691502 IN COMBINATION WITH LETROZOLE COMPARED WITH LETROZOLE ALONE IN PATIENTS WITH ESTROGEN RECEPTOR POSITIVE, HER-2 NEGATIVE EARLY BREAST CANCER - PF-4691502 PHASE 2 ER+ EARLY BREAST CANCER COMBINATION WITH LETROZOLE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 166
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. For patients enrolled in the Phase 1B - Lead-in portion:
- •Postmenopausal female patients with histologically or cytologically proven diagnosis of breast cancer with evidence of metastatic disease or locally advanced disease, not amenable to resection or radiation therapy with curative intent.
- •ER positive and HER-2 negative breast cancer (ie, immunohistochemistry (IHC) 0 or 1+; if IHC 2+, FISH or CISH negative).
- •Measurable or non measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
- •Patients must be candidates to receive letrozole as standard of care.
- •2. For patients enrolled in the Phase 2:
- •Postmenopausal women with newly diagnosed primary breast cancer.
- •ER positive and HER-2 negative breast cancer (ie, IHC 0 or 1+; if IHC 2+, FISH or CISH negative).
- •Tumor size =2 cm (as measured by ultrasound or MRI).
- •Ki-67 levels >10% positive cells determined by IHC at a central laboratory designated by the Sponsor.
- •Sufficient tumor tissue from baseline core biopsies to enable testing of biomarkers
- •For patients enrolled in Phase 1b and Phase 2:
- •3. ECOG Performance Status 0, or 1.
- •4. Adequate organ function as defined by the following criteria:
- •Absolute Neutrophil Count (ANC) =1,500/mm3 or =1.5 x 109/L.
- •Platelets =100,000/mm3 or =100 x 109/L.
- •Hemoglobin =9 g/dL.
- •Fasting blood glucose = 126 mg/dL
- •Serum Aspartate Transaminase (AST) and serum Alanine Aminotransferase Transaminase (ALT) =2.5 x upper limit of normal (ULN).
- •Alkaline phosphatase =2.5 x ULN.
- •Total serum bilirubin =1 x ULN.
- •Serum creatinine =1.5 x ULN or estimated creatinine clearance =60 mL/min as calculated using the method standard for the institution.
- •5. Adequate cardiac function, including:
- •12 Lead electrocardiogram (ECG) with normal tracing or non clinically significant changes that do not require medical intervention.
- •QTc interval =470 msec (mean of replicate values, correction per institutional standard) and no history of Torsades des Pointes or other symptomatic QTc abnormality.
- •6. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade =1.
- •7. At least 2 weeks since any prior hormone replacement therapy or phyto oestrogens herbal alternatives, or OTC sex hormone remedies.
- •8. Evidence of a personally signed and dated informed consent form document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
- •9. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
- •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 76
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1. Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the trial.
- •2. Clinical presentation of inflammatory carcinoma.
- •3. (For patients enrolled in the Phase 2) Patients unwilling to undergo core biopsies after 2 and 6 weeks of treatment.
- •4. (For patients enrolled in the Phase 1B - Lead-in portion) Presence of active brain metastases, presence of spinal cord compression, or carcinomatous meningitis, or leptomeningeal disease. Patients with previously diagnosed brain metastases are eligible if they have completed their CNS treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable.
- •5. Prior therapy with an agent that is known or proposed to be active by action on PI3K and/or mTOR.
- •6. Known hypersensitivity to letrozole or to any of the excipients.
- •7. Any surgery (not including minor procedures such as lymph node biopsy, primary tumor core biopsy, fine needle aspiration) within 4 weeks of start of study treatment; or not fully recovered from any side effects of previous procedures.
- •8. Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma.
- •9. Current use or anticipated need for food or drugs that are known potent CYP3A4 inhibitors.
- •10. Current or anticipated need for food or drugs that are known potent CYP3A4 inducers.
- •11. Concurrent administration of herbal preparations.
- •12. Any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drugs, such as the inability to take oral medication in tablet form and malabsorption syndrome.
- •13. Any mental disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this protocol.
- •14. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and in the judgement of the investigator would make the patient inappropriate for entry into this study.
- •15. Participation in other studies within 4 weeks before the current study begins and/or during study participation.
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