A randomized, multicenter, open-label, phase II trial to evaluate the efficacy and safety of palbociclib in combination with fulvestrant or letrozole in patients with HER2 negative, ER+ metastatic breast cancer. - PARSIFAL 1

Medica Scientia Innovation Research (MedSIR)0 sites486 target enrollmentSeptember 10, 2015

Overview

No summary available.

Registry

who.int

Start Date

September 10, 2015

End Date

January 31, 2020

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Medica Scientia Innovation Research (MedSIR)

•1\. Postmenopausal women, as defined by any of the following criteria:
•\- Age 60 or over
•\- Age 45 to 59 years and meets \= 1 of the following criteria:
•\- Amenorrhea for \= 24 months
•\- Amenorrhea for \< 24 months and follicle\-stimulating hormone within
•the postmenopausal range (including patients with hysterectomy, prior
•hormone replacement therapy, or chemotherapy\-induced amenorrhea)
•\- Over 18 years of age and bilateral oophorectomy
•2\. Eastern Cooperative Oncology Group (ECOG) score lower or equal to 2
•3\. Histologically confirmed recurrent ER positive (oestrogen and/or progesterone) HER2\-negative locally advanced or metastatic BC patients. Patients are not eligible if they are candidates for a local treatment with a radical intention.

•Patients will be excluded from the study if they meet ANY of the following criteria:
•1\. ER or HER2 unknown disease
•2\. HER2 positive disease based on local laboratory results (performed by immunohistochemistry/FISH)
•3\. Locally advanced breast cancer candidate for a radical treatment.
•4\. Prior endocrine therapy in the metastatic setting. (Neo)/Adjuvant endocrine therapy is allowed only if the disease\-free interval between the end of endocrine therapy and the appearance of metastases in higher than 12 months.
•5\. Patients with rapidly progressive visceral disease or visceral crisis.
•6\. Have had a major surgery (defined as requiring general anaesthesia) or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study.
•7\. Patients with an active, bleeding diathesis.
•8\. Have a serious concomitant systemic disorder (e.g. active infection including HIV, or cardiac disease) incompatible with the study (at the discretion of investigator), previous history of bleeding diathesis, or anti\-coagulation treatment (The use of low molecular weight heparin is allowed as soon as it is used as prophylaxis intention).
•9\. Are unable to swallow tablets.