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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

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT02142868
Enrollment
Unknown
Registered
2014-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2018-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Breast Cancer (Female)

Keywords

Expanded Access, Advanced Breast Cancer

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.

Interventions

DRUGPalbociclib

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)

DRUGLetrozole

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.

Sponsors

Pfizer
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026