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
NCT02142868
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- 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)
- Patients who have previously participated in a palbociclib trial or who have received
prior treatment with any CDK inhibitor
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Descriptive Information | |||||
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Brief Title | 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 | ||||
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 | ||||
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). | ||||
Detailed Description | This study is currently available in Canada only. | ||||
Study Type | Expanded Access | ||||
Expanded Access Type | Individual Patients | ||||
Condition | Advanced Breast Cancer (Female) | ||||
Intervention |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Expanded Access Status | No longer available | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Canada, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT02142868 | ||||
Other Study ID Numbers | A5481034 | ||||
Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | December 2018 |