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Trial record 1 of 1 for:    NCT02142868
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Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate

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ClinicalTrials.gov Identifier: NCT02142868
Expanded Access Status : No longer available
First Posted : May 20, 2014
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
To provide access to palbociclib to post-menopausal women with HR-positive, HER2-negative advanced breast cancer who are deemed appropriate for letrozole therapy (Canada: first-line patients only).

Condition or disease Intervention/treatment
Advanced Breast Cancer (Female) Drug: Palbociclib Drug: Letrozole

Detailed Description:
This study is currently available in Canada only.

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: AN EXPANDED ACCESS 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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Palbociclib
    Palbociclib will be administered orally once a day at 125 mg/day for 21 days followed by 7 days off treatment for each 28-day cycle (Schedule 3/1)
    Other Name: Ibrance
  • Drug: Letrozole
    Letrozole will be administered orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information.
    Other Name: Femara

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-menopausal women 18 years of age or above with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)
  • ER-positive and/or PR-positive tumor based on local laboratory results
  • HER2-negative tumor based on local laboratory results
  • Patients must be appropriate candidates for letrozole therapy (Canada: first-line patients only)

Exclusion Criteria:

  • Patients who have previously participated in a palbociclib trial or who have received prior treatment with any CDK inhibitor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142868


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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02142868     History of Changes
Other Study ID Numbers: A5481034
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

Keywords provided by Pfizer:
Expanded Access
Advanced Breast Cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Palbociclib
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protein Kinase Inhibitors