Trial | NCT02549430  Report issue

Title

To Reverse ENDocrine Resistance Trial - PD 0332991 Monotherapy vs PD 0332991 in Combination With the Endocrine Therapy
Phase 2,Open-label,Multicenter,Randomized Study of PD0332991 (Oral CDK4/6 Inhibitor) Monotherapy and in Combination With the HT to Which the pt Has Progressed in the Previous Line for ER+,Her2- Post-menopausal Advanced Breast Cancer Pts

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    115
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 Started
Oct 31
2012
Primary Completion
Feb 09
2017
Study Completion
Feb 09
2017
Last Update
Aug 01
2017

Drug Palbociclib

Palbociclib 125 mg/day orally in an ongoing 3:1 schedule (3 weeks on/1 week off)

  • Other names: PD0332991

Drug Anastrozole

Continuation of prior anastrozole 1mg/day orally in a continuous regimen

Drug Letrozole

Continuation of prior letrozole 2.5mg/day orally in a continuous regimen

Drug Exemestane

Continuation of prior exemestane 25mg/day orally in a continuous regimen

Drug Fulvestrant

Continuation of prior fulvestrant 500mg intramuscular injection every 4 weeks in a continuous regimen

Arm A Experimental

Palbociclib monoterapy

Arm B Experimental

Palbociclib + HT (Anastrozole, Letrozole, Exemestane, Fulvestrant)

Criteria 

Inclusion Criteria:

Histologically proven diagnosis of adenocarcinoma of the breast with evidence of metastatic disease
ER positive tumor ≥ 10%
HER2 negative breast cancer by FISH or IHC
Progression of advanced breast cancer on first or second line endocrine therapy for advanced breast cancer
Paraffin-embedded tumor available for centralized assessment of biomarkers
Measurable disease according to RECIST 1.1 (bone only disease is allowed only if measurable).
Postmenopausal status
Eastern Cooperative Oncology Group (ECOG) Performance status 0 -2
Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade >1
Adequate organ function

Exclusion Criteria:

Unstable brain metastases
Prior treatment with more than one line of CT or more than two lines of HT advanced breast cancer or any CDK inhibitor
Current treatment with therapeutic doses of anticoagulant
Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors / inducers, drugs that are predominantly metabolized by CYP3A with narrow therapeutic indices, drugs with the potential of prolonging QT interval
Diagnosis of any secondary malignancy within the last 3 years
Active inflammatory bowel disease or chronic diarrhea
Known human immunodeficiency virus infection; active hepatitis C, active hepatitis B
No Results Posted