This study aims to assess the activity of PD0332991 in monotherapy and in combination with the endocrine therapy (anastrozole, letrozole, exemestane or fulvestrant) on which the patient has progressed in the previous line for advanced breast cancer in order to reverse endocrine resistance.
In a clinical context, there is a lack of molecular compounds with demonstrated clinical activity in delaying/reversing resistance to endocrine agents. CDK 4/6 inhibitors may represent a biologically-driven option in this context. With the present study investigators aim to complement the ongoing trial on PD0332991 by acquiring information on its clinical activity in post-menopausal patients with ER positive, Her2 negative advanced breast cancer patients already pretreated with a first-line or second line endocrine therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Palbociclib 125 mg/day orally in an ongoing 3:1 schedule (3 weeks on/1 week off)
Continuation of prior anastrozole 1mg/day orally in a continuous regimen
Continuation of prior letrozole 2.5mg/day orally in a continuous regimen
Azienda Ospedaliera Papa Giovanni Xxiii
Bergamo, Italy
Ospedale Antonio Perrino
Brindisi, Italy
Istituto Europeo Oncologia
Milan, Italy
A.O.U. Federico Ii Di Napoli
Naples, Italy
Incidence of complete response (CR), partial response (PR) or stable disease (SD) ≥24 weeks (clinical benefit)
All randomized patients with adequate baseline disease assessment with measurable disease, the disease under study and who start treatment on the assigned arm will be considered evaluable for clinical benefit (CB). The probability of CB on each randomized treatment arm will be estimated by dividing the number of patients with CB by the number of evaluable patients randomized to the treatment arm.
Time frame: Baseline up to 3 years
Progression free survival (PFS)
PFS is the time from randomization date to date of first documentation of progression or death due to any cause, whichever occurs first. Documentation of progression must be by objective disease assessment as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. All patients randomized will be considered evaluable for PFS.
Time frame: Baseline up to 3 years
Objective Response (OR)
All randomized patients with adequate baseline disease assessment with measurable disease, the disease under study and who start treatment on the assigned arm will be considered evaluable for objective response (CR or PR). The probability of OR on each randomized treatment arm will be estimated by dividing the number of patients with OR by the number of evaluable patients randomized to the respective treatment arm ("response rate").
Time frame: Baseline up to 3 years
Overall Survival (OS)
OS is the time from randomization date to date of death due to any cause. All patients randomized will be considered evaluable for OS.
Time frame: Baseline up to 6 years
Time to Progression (TTP)
TTP is the time from randomization date to date of first documentation of objective progression. All patients randomized will be considered evaluable for TTP.
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Continuation of prior exemestane 25mg/day orally in a continuous regimen
Continuation of prior fulvestrant 500mg intramuscular injection every 4 weeks in a continuous regimen
Fondazione Maugeri
Pavia, Italy
A.O.U. S. Maria Della Misericordia Di Udine
Udine, Italy
Time frame: Baseline up to 3 years
Duration of Response (DR)
For patients with an objective response (CR or PR), duration of response is the time from first documentation of CR or PR to date of first documentation of objective progression or death. Date of first documentation of progression and date of first documentation of CR or PR will be based on investigator assessment of response.
Time frame: Baseline up to 3 years