Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer

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Pfizer

Status and phase

Completed
Phase 4

Conditions

Breast Cancer

Treatments

Drug: Palbociclib
Drug: Letrozole

Study type

Interventional

Funder types

Industry

Identifiers

NCT02679755
A5481037

Details and patient eligibility

About

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.

Full description

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.

Enrollment

252 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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.

Trial design

252 participants in 1 patient group

Experimental arm
Experimental group
Description:
Palbociclib plus Letrozole
Treatment:
Drug: Letrozole
Drug: Palbociclib

Trial documents
2

Trial contacts and locations

34

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Data sourced from clinicaltrials.gov

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