Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic … (NCT02947685) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer
United States518 participantsStarted 2017-06-21
Plain-language summary
The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed Preliminary Screening Informed Consent Form obtained prior to any study specific assessments and procedures
✓. Age ≥18 years (or per national guidelines)
✓. Patients must have histologically confirmed invasive breast cancer that is metastatic or not amenable for resection or radiation therapy with curative intent. Histological documentation of metastatic/recurrent breast cancer is not required if there is unequivocal evidence for recurrence of the breast cancer.
✓. Patients must have histologically confirmed HER2+ and hormone receptor positive (ER+ and/or PR+), metastatic breast cancer. ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting in the US or certified laboratories for Non-US regions. Cut-off values for positive/negative staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines.
✓. Patients must agree to provide a representative formalin-fixed paraffin-embedded (FFPE) tumor tissue block (preferred) from primary breast or metastatic site (archival) OR at least 15 freshly cut unstained slides from such a block, along with a pathology report documenting HER2 positivity and hormone receptor positivity.
✓. Patients should be willing to provide a representative tumor specimen obtained from recently biopsied metastatic disease if clinically feasible. This is recommended but optional tissue.
✓. Signed Main Informed Consent Form obtained prior to any study specific assessments and procedures
✓. Age ≥ 18 years (or per national guidelines)
Exclusion criteria
What they're measuring
1
Progression-free Survival (PFS) as Assessed by Investigator
✕. Concurrent therapy with other Investigational Products.
✕. Prior therapy with any CDK 4/6 inhibitor.
✕. History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib.
✕. Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization (see Section 8.6.3 for list of strong inhibitors or inducers of CYP3A isoenzymes).
✕. Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation.
✕. Pregnant women, or women of childbearing potential without a negative pregnancy test (serum or urine) within 7 days prior to randomization, irrespective of the method of contraception used, are excluded from this study because the effect of palbociclib on a developing fetus is unknown. Breastfeeding must be discontinued prior to study entry.
✕. Patients on combination antiretroviral therapy, i.e. those who are HIV-positive, are ineligible because of the potential for pharmacokinetic interactions or increased immunosuppression with palbociclib.
✕. QTc interval \>480 msec, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes.