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

CompletedPhase 4

Sponsor: Pfizer

Conditions: Breast Cancer

Interventions: Palbociclib, Letrozole

Countries: Australia, India

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (34)

North Sydney, New South Wales, Australia
North Sydney, New South Wales, Australia
North Sydney, New South Wales, Australia
North Sydney, New South Wales, Australia
North Sydney, New South Wales, Australia
St Leonards, New South Wales, Australia
St Leonards, New South Wales, Australia
Auchenflower, Queensland, Australia
Auchenflower, Queensland, Australia
Chermside, Queensland, Australia
South Brisbane, Queensland, Australia
South Brisbane, Queensland, Australia
Southport, Queensland, Australia
Bedford Park, South Australia, Australia
Bedford Park, South Australia, Australia
Clayton, Victoria, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
St Albans, Victoria, Australia
St Albans, Victoria, Australia
Murdoch, Western Australia, Australia
Murdoch, Western Australia, Australia
Ahmedabad, Gujarat, India
Bangalore, Karnataka, India
Bangalore, Karnataka, India
Manipal, Karnataka, India
Mumbai, Maharashtra, India
Nagpur, Maharashtra, India
Nashik, Maharashtra, India
Pune, Maharashtra, India
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