Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Posit… (NCT02630693) | Clinical Trial Compass
CompletedPhase 2
Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive, HER2 Neg Advanced/Metastatic Breast Cancer
Canada180 participantsStarted 2016-04-08
Plain-language summary
The purpose of this study is to determine if the combination of endocrine therapy and Palbociclib at a daily dose of 100 mg will result in a better response to therapy with fewer dose interruptions than the proposed dosing regimen of 125 mg daily for 21 days out of a 28 day cycle in combination with endocrine therapy.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Premenopausal and postmenopausal women 18 years of age or older.
* Histologically confirmed adenocarcinoma of the breast, with ER positive and HER2 negative status based on local testing on most recent pathological tumour specimen.
* Patients must satisfy the following criteria for prior therapy:
* Progressed during treatment or within 12 months of completion of adjuvant endocrine therapy or
* Progressed during prior endocrine therapy for advanced/metastatic disease. Note: 'Progressed during endocrine therapy' means that the patient progressed while on or within 1 month after discontinuation of endocrine therapy.
* One line of chemotherapy for advanced/metastatic disease (regardless of prior adjuvant chemotherapy use) is allowed in addition to endocrine therapy.
* Patients must have evidence of disease to be eligible for the study, but measurable disease is not mandatory.
* For those patient with measureable disease who will be included in the response assessment, the following criteria must apply:
* X-ray ≥ 20 mm
* Spiral CT scan or physical exam ≥ 10 mm (lymph nodes must be ≥ 15 mm in the short axis)
* Conventional CT scan, MRI ≥ 20 mm
* Measurable lesions must be outside a previous radiotherapy field if they are the sole site of disease, unless disease progression has been documented.
Tumor lesions previously irradiated or subjected to other loco regional therapy will only be deemed measurable if progression at the treated site after c…
What they're measuring
1
Progression Free Survival Using the RECIST 1.1 Criteria