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Closed (no longer recruiting)Last updated: 20 December 2023

This phase IV trial is looking at palbociclib in combination with letrozole, for the treatment hormone receptor positive, HER 2 negative advanced breast cancer in postmenopausal womenA 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

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 patients with hormone receptor positive and HER 2 negative breast cancer.

Cancer

Breast Cancers Breast

Age

People18+

Phase

IV

More information

Trial Identifiers

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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

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.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

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