ISRCTN31243262已完成2 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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 306
研究概览
简要总结
2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30523750 results (added 26/02/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Postmenopausal women defined as:
- •1.1. Age 56 or older with no spontaneous menses for at least 12 months prior to study entry
- •1.2. Age 55 or younger with no menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) and with a documented oestradiol level in the postmenopausal range according to local institutional/laboratory standard
- •1.3. 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) [sentence added 01/11/2016]. HER2 negativity will be defined as per the 2013 ASCO/CAP guidelines as follows:
- •2.1. IHC 1+ as defined by incomplete membrane staining that is faint/barely perceptible and within >10% of the invasive tumour cells
- •2.2. 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
- •2.3. ISH negative based on:
- •2.3.1. Single-probe average HER2 copy number <4.0 signals/cell
- •2.3.2. 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:
- •7.1.Haemoglobin =10g/dL (90g/L)
- •7.2. ANC = 1,500/ mm³ (> 1.5 x 109/L)
- •7.3. Platelets = 100,000/mm³ (> 100 x 109/L)
- •7.4. AST and/or ALT 1.5 x upper normal limits (ULN)
- •7.5 Alkaline phosphatase 1.5 x ULN
- •7.6. 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
- •7.7. Serum creatinine = 1.25 x ULN or estimated creatinine clearance < 60 mL/min (as calculated using the method standard for the institution)
- •7.8. No severe and relevant co-morbidity that would affect a patient?s participation in the study
- •7.9. 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
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. Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ)
- •7. Bilateral invasive disease (added 01/11/2016)
- •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 Hearth 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 know 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
相似试验
已完成
2 期
A study of the drugs AZD2014 and rituximab in relapsed or refractory diffuse large B-cell lymphomaTopic: CancerSubtopic: LymphomaDisease: Lymphoma (other)CancerISRCTN10760016niversity of Birmingham36
进行中（未招募）
2 期
A phase II trial of Cediranib in the treatment of patients with Alveolar Soft Part SarcomaSarcomaCancerAlveolar soft part sarcomaISRCTN63733470The Institute of Cancer Research/Royal Marsden Hospital NHS Foundation Trust (UK)48
已完成
2 期
Prevention of sagopilone-induced neurotoxicity with acetyl-L-carnitine (ALC)Ovarian cancerCancerISRCTN75009754Bayer Schering Pharma AG (Germany)271
已完成
2 期
Quicksilver: a study to assess the safety of a new MRI approach to pre-operatively stage rectal cancer and guide treatmentRectal cancerCancerISRCTN05107772Mount Sinai Hospital (Canada)82
已完成
2 期
Study of the effectiveness of the addition of Capecitabine to a standard regimen containing Adriamycin®, Cyclophosphamide and Docetaxel as neoadjuvant treatment in large or locally advanced breast cancersarge or locally advanced breast cancerMalignant neoplasm of breastCancerISRCTN00407556nited Lincolnshire Hospitals NHS Trust (UK)130