Metastatic Breast Cancer – Oncology Not applicable
Conditions
Interventions
MEDICINAL PRODUCT{S}: Palbociclib
Not applicable
Sponsors
AMCI (Africa Middle East Cancer Intergroup)/Investigator Initiated Research
Eligibility
Sex/Gender
Female
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all the following inclusion criteria to be eligible for enrolment into the study: 1. Adult women (= 18 years of age) with metastatic or locally advanced breast cancer (histologically or cytologically proven diagnosis of adenocarcinoma of the breast) not amenable to curative treatment by surgery or radiotherapy. 2. ER positive tumour: Histological or cytological confirmation of estrogen and/or progesterone-receptor positive, as determined by routine IHC. Positivity is defined as =1% positive stained cells. The receptor status determined by utilizing an assay consistent with local laboratory standards. 3. HER2 negative breast cancer as confirmed by IHC, SISH or FISH. 4. Premenopausal women : (definition of a real menopause is not a simple task in these relatively young women, owing to the potential effect of prior chemotherapy and /or endocrinal therapy particularly OFS) defined either by: i. Any age below 40 years , irrespective to E2 level or menstrual history ii. If the woman had a menstrual period any time within the last 12 months iii. If the woman has amenorrhea of more than 12 months (in the absence of chemotherapy or ovarian function suppression) that is associated with serum hormone levels that are NOT in the postmenopausal range (either estradiol (E2) 100 x109/L iii. Hemoglobin (Hgb) > 9.0g/dL iv. INR < 2 v. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5x ULN (or <5 if hepatic metastases are present) vi. Total serum bilirubin < 1.5 x ULN (<3 x ULN for patients known to have Gilberts Syndrome) vii. Serum creatinine < 1.5 x ULN viii. QTc< 470 msec (based on the mean value of the triplicate ECGs). 10. Written informed consent obtained before any trial related activity and according to local guidelines.
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the study: 1. Postmenopausal women. Postmenopausal status is defined by age>40years with amenorrhea of more than 12 months, associated with serum hormonal levels of the postmenopausal range (either estradiol (E2) 3 x ULN iii. Acute and chronic active infectious disorders (except for Hepatitis B and Hepatitis C positive patients) and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy iv. Known human immunodeficiency virus infection v. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Name: Progression Free Survival (PFS)* as assessed by the Investigator. ;Timepoints: Primary Endpoint: - Progression Free Survival (PFS)* as assessed by the Investigator. *PFS will be defined as the time from randomization to the time of disease progression or death for both treatment arms. ;Measure: Primary Endpoint: - Progression Free Survival (PFS)* as assessed by the Investigator. *PFS will be defined as the time from randomization to the time of disease progression or death for both treatment arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Name: Objective Response (OR): Complete Response (CR) or Partial Response (PR). ;Timepoints: Objective Response (OR): Complete Response (CR) or Partial Response (PR). ;Measure: Objective Response (OR): Complete Response (CR) or Partial Response (PR). ;Name: Clinical benefit Rate (CBR): Complete Response + Partial Response + Stable Disease (SD) for ? 24 weeks ;Timepoints: Clinical benefit Rate (CBR): Complete Response + Partial Response + Stable Disease (SD) for ? 24 weeks ;Measure: Clinical benefit Rate (CBR): Complete Response + Partial Response + Stable Disease (SD) for ? 24 weeks ;Name: Overall Survival (OS) ;Timepoints: Overall Survival (OS) ;Measure: Overall Survival (OS) ;Name: Overall treatment safety: Type, incidence and severity of adverse events (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.0) ;Timepoints: Overall treatment safety: Type, incidence and severity of adverse events (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.0) ;Measure: Overall treatment safety: Type, incidence and severity of adverse events (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.0) | — |
Countries
Algeria, Egypt, Lebanon, South Africa
Contacts
Public ContactMarwan Ghosn
Hotel Dieu de France Hospital
Outcome results
None listed