EUCTR2014-000887-16-GB进行中（未招募）1 期
A phase II randomised study evaluating the biological and clinical effects of the combination of palbociclib with letrozole as neoadjuvant therapy in post-menopausal women with ER+ primary breast cancer. - PALLET
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 306
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. Postmenopausal women defined as:
- •i. Age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or
- •ii. Age 55 or younger with no menses for at least 12 months prior to study entry (e.g., spontaneous or after hysterectomy) and with a documented oestradiol level in the postmenopausal range according to local institutional/laboratory standard; or
- •iii. Age =16 with documented bilateral oophorectomy
- •2. Operable ER+ HER2- invasive early breast cancer suitable for neoadjuvant AI treatment. ER positivity is defined as an Allred score of 3 (or equivalent). HER2 negativity will be defined as per the 2013 ASCO/CAP guidelines as follows:
- •i. IHC 1+ as defined by incomplete membrane staining that is faint/barely perceptible and within >10% of the invasive tumour cells; or
- •ii. IHC 0 as defined by no staining observed or membrane staining that is incomplete and is faint/barely perceptible and within =10% of the invasive tumour cells; or
- •iii. ISH negative based on:
- •o Single-probe average HER2 copy number <4.0 signals/cell
- •o Dual-probe HER2/CEP17 ratio <2.0 with an average HER2 copy number <4.0 signals/cell
- •3. No medical contra-indication to palbociclib (as defined according to latest version of Investigator Brochure)
- •4. A tumour with an ultrasound size of at least 2.0cm
- •5. No evidence of metastatic spread by standard assessment according to local guidelines
- •6. ECOG performance status of 0 or 1
- •7. Adequate organ function including:
- •a) haemoglobin =10g/dL (100g/L)
- •b) ANC = 1,500/mm³ (> 1.5 x 10^9/L)
- •c) platelets =100,000/mm³ (> 100 x 10^9/L)
- •d) AST and/or ALT <1.5 x x upper normal limits (ULN)
- •e) Alkaline phosphatase <1.5 x ULN
- •f) total serum bilirubin < ULN unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin
- •g) serum creatinine =1.25 x ULN or estimated creatinine clearance > 60 mL/min (as calculated using the method standard for the institution)
- •h) no severe and relevant co-morbidity that would effect a patient’s participation in the study
- •i) INR must be within normal limits of the local laboratory ranges
- •8. Written informed consent to participate in the trial and to donation of tissue and blood samples
- •9. Patients must have the ability to swallow oral medication
- •Are the trial subjects under 18? yes
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Premenopausal or perimenopausal women
- •2. Inflammatory/inoperable breast cancer
- •3. HER2 positive
- •4. Concurrent use (defined as use within 4 weeks prior to baseline tissue sample being taken) of HRT or any other oestrogen-containing medication (including vaginal oestrogens)
- •5. Prior endocrine therapy for breast cancer
- •6. Bilateral invasive disease
- •7. Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ)
- •8. Any severe coincident medical disease, including seizure disorder requiring medication
- •9. Diagnosis by FNA alone or excisional biopsy or lumpectomy performed prior to study entry
- •10. Surgical axillary staging procedure prior to study procedure (with the exception of FNA or core biopsy)
- •11. Definitive clinical or radiologic evidence of metastatic disease
- •12. History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with radiotherapy or contralateral invasive breast cancer at any time
- •13. New York Heart Association classification of level III or IV heart disease
- •14. Any treatment, including radiotherapy, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry
- •15. Patients on established CYP3A inhibitors/inducers
- •16. QTc > 480 msec or a family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP).
- •17. Active Hepatitis B or Hepatitis C with abnormal liver function tests.
- •18. HIV positive patients receiving antivirals.
研究者
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