EUCTR2011-005932-24-IT进行中（未招募）不适用
A randomized, double-blind, placebo controlled, phase II study of BKM120 plus paclitaxel in patients with HER2 negative inoperable locally advanced or metastatic breast cancer, with or without PI3K pathway activation - BELLE 4
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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. Patient is an adult, female = 18 years old at the time of informed consent
- •2. Patient has histologically and/or cytologically confirmed diagnosis of breast cancer
- •3. Patient has radiologic evidence of inoperable locally advanced, or metastatic breast cancer
- •4. Patient has HER2 negative disease (based on most recently analyzed biopsy) defined as a negative immunohistochemistry, fluorescent, non-florescent chromogenic or silver in situ
- •hybridization (respectively FISH/CISH/SISH) test or an IHC status of 0, 1+ or 2+ (if IHC 2+, a negative SISH/FISH/CISH test is required) by local laboratory testing
- •5. Patient has a known PI3K pathway status (activated or non-activated based on results from a Novartis designated laboratory prior to the start of treatment)
- •A representative archival or fresh tumor biopsy must be shipped to a Novartis
- •designated laboratory for profiling and results obtained prior to randomization
- •through IRT
- •Note: one block or = 15 unstained slides are required to determine the PI3K activation
- •status. Whenever possible = 20 unstained slides is preferred.
- •6. Patient has a known ER/PgR status (either positive or negative) by local laboratory testing
- •7. Patient has measurable or non-measurable disease according to RECIST 1.1 criteria
- •8. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status = 1
- •which the investigator believes is stable at the time of screening
- •9. Patient has adequate bone marrow and organ function as defined by the following
- •laboratory values:
- •a. Absolutely Neutrophil Count (ANC) = 1.5 x 109/L
- •b. Platelets = 100 x 109/L
- •Hemoglobin = 9.0 g/dL
- •d. INR = 1.5
- •e. Potassium and calcium (corrected for albumin), within normal limits for the
- •institution
- •f. Serum creatinine = 1.5 x ULN and/or creatinine clearance > 45 mL/min
- •g. Total serum bilirubin within normal range (or = 1.5 x ULN if liver metastases are
- •present; or total bilirubin = 3.0 x ULN with direct bilirubin within normal range in
- •patients with well documented Gilbert’s Syndrome, which is defined as presence of
- •several episodes of unconjugated hyperbilirubinemia with normal results from CBC
- •count (including normal reticulocyte count and blood smear), normal liver function
- •test results, and absence of other contributing disease processes at the time of
- •diagnosis (see Appendix in the final protocol)]
- •h. Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) within normal
- •range (or < 3.0 x ULN if liver metastases are present)
- •i. Fasting plasma glucose (FPG) = 120mg/dL or = 6.7 mmol/L
- •j. HbA1c = 8 %
- •10. Patient is able to swallow and retain oral medication
- •11. Patient has signed the Informed Consent (ICF) prior to any screening procedures being performed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1. Patient has received previous treatment with a PI3K inhibitor
- •2. Patient has received any prior systemic therapies (except endocrine therapy) for the
- •inoperable locally advanced (recurrent or progressive) or metastatic disease. Study
- •treatment in this study must be the patient’s first chemotherapy treatment for inoperable
- •locally advanced or metastatic disease. Any number of prior endocrine therapies is
- •Note: Adjuvant/neoadjuvant therapy will be counted as prior line of therapy for
- •metastatic/recurrent disease if the patient had a progression/recurrence within 6
- •months after completion of the therapy (12 months for taxane-based therapy).
- •3. Patient has symptomatic CNS metastases
- •Patients with asymptomatic CNS metastases may participate in this trial. The patient
- •must have completed any prior local treatment for CNS metastases = 28 days prior to
- •the start of study treatment (including radiotherapy and/or surgery) and must have
- •completed corticosteroid therapy.
- •4. Patient has a concurrent malignancy or malignancy within 3 years of study enrollment,
- •(with the exception of adequately treated, basal or squamous cell carcinoma, nonmelanomatous
- •skin cancer or curatively resected cervical cancer)
- •5. Patient has been treated with any hematopoietic colony-stimulating growth factors (e.g.,
- •G-CSF, GM-CSF) = 2 weeks prior to starting study drug. Erythropoietin or darbepoetin
- •therapy, if initiated before enrollment, may be continued
- •6. Patient has received wide field radiotherapy = 4 weeks or limited field radiation for
- •palliation = 2 weeks prior to starting study drug or who have not recovered to grade 1 or
- •better from related side effects of such therapy (exceptions include alopecia, bone marrow
- •and organ functions (limits described in Inclusion 7))
- •7. Patient is currently receiving increasing or chronic treatment (> 5 days) with
- •corticosteroids or another immunosuppressive agent, as chronic administration of
- •corticosteroids (> 5 days) can induce CYP3A4.
- •The following uses of corticosteroids are permitted: single doses; standard
- •premedication for paclitaxel; Topical applications (e.g., rash), inhaled sprays (e.g.,
- •obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
- •8. Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for
- •treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin
- •(LMWH), or fondaparinux is allowed
- •9. Patient is currently receiving treatment with drugs known to be moderate or strong
- •inhibitors or inducers of isoenzyme CYP3A. The patient must have discontinued strong
- •inducers for at least one week and must have discontinued strong inhibitors before the
- •treatment is initiated. Switching to a different medication prior to randomization is
- •allowed. Please refer to the Table 14-1 in Appendix 1 for a list of strong and moderate
- •inhibitors and inducers of CYP3A4.
- •10. Patient has a known hypersensitivity to paclitaxel or other products containing Cremophor
- •11. Patient has a contraindication to use the paclitaxel standard pre-treatment such as
- •corticosteroids
- •12. Patient has had major surgery within 14 days prior to starting study drug or has not
- •recovered from major side effects
- •13. Patient has a score = 12 on the PHQ-9 questionnaire.
- •Further exclusion criteria are listed in the protocol
研究者
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