Trial purpose
Cancer treatment
Tumor type
Breast
Age
18+
Clinical summary
Summary
To provide access to palbociclib to post-menopausal patients with hormone receptor-positive [HR(+)], HER2-negative [HER2(-)] ABC who are deemed appropriate for letrozole therapy.
Conditions
This trial is treating people with hormone receptor positive and HER 2 negative breast cancer
Eligibility
Inclusion
- Post-menopausal women (>=18 years of age) with proven diagnosis of advanced carcinoma of the breast (ER(+) and/or PgR(+) and HER2(-)) who are appropriate for letrozole therapy (in the first-line advanced/metastatic disease setting).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate bone marrow, liver, and renal function.
Exclusion
- Prior treatment with any CDK inhibitor .
- QTc >480 msec; history of QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.
- High cardiovascular risk, including, but not limited to myocardial infarction, severe/unstable angina, severe cardiac dysrhythmias, and symptomatic pulmonary embolism in the past 6 months of enrollment.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Pfizer
Scientific Title
A Study Of Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate
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