Tests palbociclib with hormone therapy in women with advanced breast cancer

Who can take part

• To be enrolled in the study, patients should meet the following inclusion criteria:
• Written informed consent before beginning specific protocol procedures including expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to the local regulatory requirements
• Postmenopausal women or pre/peri-menopausal women with Surgical oophorectomy (preferred) or Analogs of LHRH
• Performance status < 3 (according to WHO criteria)
• Histologically confirmed breast cancer (Luminal A or B)
• Estrogen Receptor positive (ER > 1%)
• HER2 negative (score 0 or 1 by immunochemistry), FISH negative if IHC score 2
• Clinical stage IIIb \& IV
• Either:; Women with De novo advanced luminal HER2 negative advanced breast cancer without other prior systemic treatment for advanced disease; Women with luminal HER2 negative advanced breast cancer either with secondary resistance (relapse after 2 years of adjuvant hormone therapy or within 12 months of completion of adjuvant HT) or sensitivity to adjuvant HT (relapse > 12 months after completion of adjuvant HT)
• Measurable or evaluable disease
• Hematology:; Neutrophil count ≥ 1.5 G/L,; Platelet count ≥ 100 G/L,; Leucocyte count > 3.0 G/L,; Hb> 9g/dl
• Hepatic function:; Total bilirubin ≤ 1.5 times the upper normal limit (UNL),; ASAT ≤ 2.5xUNL,; ALAT ≤ 2.5xUNL,; Alkaline phosphatase ≤ 2.5 times the upper normal limit (UNL)
• Renal function:; Serum creatinine ≤1.5xUNL (and if Serum creatinine >1.5xUNL, creatinine clearance ≥40 mL/min),
• Metabolic function:; Serum calcium ≥ lower limit of normal
• Negative pregnancy test (urine or serum) within 7 days before registration for all women of childbearing potential. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment
• Patients with negative Human Immunodeficiency Virus (HIV) and/or Hepatitis B and/or Hepatitis C results

Who cannot take part

• Known previous or ongoing abuse of narcotic drug, other medication or alcohol
• Any investigational agent within 30 days before initiation of study treatment
• Triple-negative Breast Cancer (ER<1%)
• Any form of breast cancer other than those described in the inclusion criteria, particularly inflammatory and/or loco-regional disease (stages I, II \& IIIa)
• Bilateral breast cancer
• Patients with a history of other cancer, except in situ cervical cancer or baso-cellular skin cancer, considered cured
• Patient has another disease, which is deemed incompatible with the inclusion in the protocol
• Heart, kidney, medullary, respiratory or liver failure; Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) at baseline; History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease at baseline,; Acute urinary infection, ongoing hemorrhagic cystitis at baseline
• Uncontrolled diabetes
• Symptomatic or progressive disorder of the central nervous system (CNS) at baseline
• Patients with positive Human Immunodeficiency Virus (HIV) and/or Hepatitis B and/or Hepatitis C results
• Significant psychiatric abnormalities
• History of hypersensitivity to studied treatment or excipients
• To be enrolled in the study, patients should meet the following exclusion criteria:
• Male patients
• HER2 positive tumors or unknown HR/HER2 status
• Pregnant or breast-feeding women, or those who plan to become pregnant within 6 months post-treatment
• No willingness to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months post-treatment
• Non-evaluable tumor
• Patient unwilling or unable to comply with study requirements