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

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NCT02679755

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Alexander David Guminski
North Sydney, New South Wales, 2060 Australia
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02679755
Pfizer
Recruiting
Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer

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Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
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
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.
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.
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Palbociclib
    125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles
    Other Name: IBRANCE
  • Drug: Letrozole
    2.5 mg/d tablets orally on a continuous regimen
Experimental: Experimental arm
Palbociclib plus Letrozole
Interventions:
  • Drug: Palbociclib
  • Drug: Letrozole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
July 2, 2019
July 2, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Australia,   India
 
 
NCT02679755
A5481037
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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