PALbociclib Endocrine therapy followed by Talazo vs. Talazo-Atezo (Young-PALETTA) study
- Conditions
- Neoplasms
- Registration Number
- KCT0006190
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 178
1) Histologically confirmed metastatic breast cancer with or without measurable disease
2) Patients who have stage IV breast cancer at diagnosis (de novo) or have progressed on distant metastatic sites after curative surgery
3) Confirmed germline pathogenic BRCA1 and/or 2 mutation or 35 HRD-related gene alterations
4) age > 19 years
5) ECOG performance status 0 – 2
6) Patient has HER2-negative breast cancer with IHC and/or FISH (or SISH, CISH)
7) Patient has ER positive and/or PR positive breast cancer by local laboratory testing
8) Patient is premenopausal. Premenopausal status is defined as either:
A Patient had last menstrual period within the last 12 months
B. If on tamoxifen within the past 3 months, with a plasma estradiol =10 pg/mL and FSH =40 IU/l or in the premenopausal range, according to local laboratory definition
C. in case of chemotherapy induced amenorrhea, with a plasma estradiol =10 pg/mL) and/or FSH =40IU/l or in the premenopausal range according to local laboratory definition.
9) Patient with treatment history as bellows:
A In patients with de novo metastatic breast cancer(who had stage IV disease at first diagnosis of breast cancer),
B. In patients with recurrent metastatic breast cancer, recurrence during or after completion or discontinuation of adjuvant endocrine therapy (regardless of the treatment free interval) are eligible.
C. One line of prior cytotoxic chemotherapy(except platinum based chemotherapy) in metastatic breast cancer is permitted.
10) No possibility of pregnancy and urine or serum beta-HCG negative
11) Adequate bone marrow function (= ANC 1,500/ul, = platelet 100,000/ul, = Hemoglobin 9.0 g/dl)
12) Adequate renal function (= serum creatinine 1.5 mg/dl or CCr = 650 ml/min)
13) Adequate liver function (= serum bilirubin 2.0 mg/dl, = AST/ALT x 3 upper normal limit)
14) Patients who were already established on bisphosphonate therapy or denosumab may continue.
15) Patients agreed to use effective contraception or not of childbearing potential
16) Written informed consent
17) Patients agreed to offer tumor tissue and blood for biomarker analysis
1) Postmenopausal women
2) Serious uncontrolled intercurrent infections within 4 weeks prior to Cycle 1 Day 1 of 1st Treatment
3) Serious intercurrent medical or psychiatric illness, including active cardiac disease
4) Pregnancy or breast feeding within 5 months after the last dose of atezolizumab
5) Second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or resected thyroid papillary carcinoma or other malignancy treated at least 5 years previously with no evidence of recurrence)
6) Patients has received previous endocrine treatments in the metastatic setting
7) Patients has received previous aromatase inhibitor
8) Patients has received previous treatment with CDK 4/6 inhibitors, PARP1 inhibitors, and immune check point inhibitors
9) Symptomatic visceral metastases, which means lymphangitic lung metastasis and/or symptomatic hepatic metastases
10) Known brain metastases, symptomatic or asymptomatic
11) History of clinically significant liver disease, current alcohol abuse or known active infection
12) History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus (SLE), rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
13) Prior allogeneic stem cell or solid organ transplantation
14) History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computerised tomography (CT) scan
15) Active tuberculosis
16) Receipt of a live, attenuated vaccine within 4 weeks prior to Cycle 1 Day 1 of 1st Treatment or anticipation that a live, attenuated vaccine will be required during atezolizumab treatment or within 5 months after the last dose of atezolizumab
17) Treatment with systemic immunostimulatory agents (including but not limited to interferons or interlukin [IL]-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to Cycle 1 Day 1 of 1st Treatment
18) Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, mycophenolate, and anti-tumour necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1 Day 1 of 1st Treatment, or anticipated requirement for systemic immunosuppressive medications during the trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2nd Progression free survival (PFS) of talazoparib versus talazoparib plus atezolizumab after palbociclib combination endocrine therapy. To assess measures of clinical efficacy. It is a measure of the period of survival without disease progression by Kaplan-Meier method.
- Secondary Outcome Measures
Name Time Method Composite PFS (1st PFS + 2nd PFS);overall survival (OS);toxicity assessment