Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer (PYTHIA)
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|ClinicalTrials.gov Identifier: NCT02536742|
Recruitment Status : Active, not recruiting
First Posted : September 1, 2015
Last Update Posted : February 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Palbociclib Drug: Fulvestrant||Phase 2|
Patients will be treated with the combination of palbociclib and fulvestrant. The primary objective is to assess the association of the primary endpoint progression-free survival (PFS) with potential markers.
The trial is included in the AURORA program conducted by the Breast International Group (BIG), an international study aiming to collect and characterize biological samples, including metastatic tissue, from patients with advanced breast cancer.
The primary aim of the PYTHIA study is to discover potentially innovative biomarkers for the selection of patients to Palbociclib/Fulvestrant treatment. The strength of the trial lies in its conduct in conjunction with the AURORA study, which systematically evaluates a panel of biomarkers in tissue and blood, in a certified central lab. Stemming from this association, an abundance of molecular profiling information will become available for different biological samples. Additional molecular and functional imaging assessments performed within the context of the PYTHIA study increase its scientific merit, since it will represent a prospective, systematic effort to identify biomarkers for patient stratification, integrating several molecular profiling assessments.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Palbociclib Plus Fulvestrant for Pretreated Patients With ER+/HER2- Metastatic Breast Cancer|
|Actual Study Start Date :||August 30, 2016|
|Actual Primary Completion Date :||August 28, 2020|
|Estimated Study Completion Date :||December 2021|
Palbociclib plus Fulvestrant
125 mg, orally, daily for 3 weeks followed by 1 week off; repeated at every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment.
500mg, intramuscularly on days 1 and 15 of cycle 1, then on day 1 (+/- 3 days) of every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment.
Other Name: Faslodex
- Progression Free Survival (PFS) [ Time Frame: Maximal 36 months ]Time from treatment initiation until documented disease progression according to RECIST 1.1 or death, whichever occurs first
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536742
|Study Chair:||Luca Malorni, MD PhD||USL4 Hospital of Prato, Italy|