A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE
Sponsor: Pfizer
A PHASE3 clinical study on Breast Neoplasms, this trial is completed. The trial is conducted by Pfizer and has accumulated 33 data snapshots since 2013. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Status Flow
Change History
33 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
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Dec 2024 — Sep 2025 [monthly]
Completed PHASE3
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Sep 2024 — Dec 2024 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Dec 2023 — Jul 2024 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
▶ Show 28 earlier versions
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Jan 2023 — Dec 2023 [monthly]
Active Not Recruiting PHASE3
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Nov 2022 — Jan 2023 [monthly]
Active Not Recruiting PHASE3
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Sep 2022 — Nov 2022 [monthly]
Active Not Recruiting PHASE3
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Jul 2022 — Sep 2022 [monthly]
Active Not Recruiting PHASE3
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May 2022 — Jul 2022 [monthly]
Active Not Recruiting PHASE3
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Dec 2021 — May 2022 [monthly]
Active Not Recruiting PHASE3
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Jan 2021 — Dec 2021 [monthly]
Active Not Recruiting PHASE3
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Nov 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE3
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Mar 2020 — Nov 2020 [monthly]
Active Not Recruiting PHASE3
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Nov 2019 — Mar 2020 [monthly]
Active Not Recruiting PHASE3
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Jul 2019 — Nov 2019 [monthly]
Active Not Recruiting PHASE3
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Jun 2019 — Jul 2019 [monthly]
Active Not Recruiting PHASE3
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May 2019 — Jun 2019 [monthly]
Active Not Recruiting PHASE3
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Feb 2019 — May 2019 [monthly]
Active Not Recruiting PHASE3
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Jan 2019 — Feb 2019 [monthly]
Active Not Recruiting PHASE3
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Dec 2018 — Jan 2019 [monthly]
Active Not Recruiting PHASE3
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Oct 2018 — Dec 2018 [monthly]
Active Not Recruiting PHASE3
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Aug 2018 — Oct 2018 [monthly]
Active Not Recruiting PHASE3
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Jun 2018 — Aug 2018 [monthly]
Active Not Recruiting PHASE3
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May 2018 — Jun 2018 [monthly]
Active Not Recruiting PHASE3
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Mar 2018 — May 2018 [monthly]
Active Not Recruiting PHASE3
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Nov 2017 — Mar 2018 [monthly]
Active Not Recruiting PHASE3
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Oct 2017 — Nov 2017 [monthly]
Active Not Recruiting PHASE3
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Aug 2017 — Oct 2017 [monthly]
Active Not Recruiting PHASE3
Status: Suspended → Active Not Recruiting
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Jul 2017 — Aug 2017 [monthly]
Suspended PHASE3
Status: Active Not Recruiting → Suspended
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Jun 2017 — Jul 2017 [monthly]
Active Not Recruiting PHASE3
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Feb 2017 — Jun 2017 [monthly]
Active Not Recruiting PHASE3
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Jan 2017 — Feb 2017 [monthly]
Active Not Recruiting PHASE3
First recorded
Feb 2013
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Pfizer
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
A Coruña, Spain , Adelaide, Australia , Alcorcón, Spain , Anger Cedex 02, France , Ann Arbor, United States , Atlanta, United States , Auchenflower, Australia , Avellino, Italy , Badajoz, Spain , Badalona, Spain and 206 more locations