CompletedPhase 3

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

United States666 participantsStarted 2013-02-22

Plain-language summary

The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy. * Confirmed diagnosis of ER positive breast cancer * No prior systemic anti-cancer therapy for advanced ER+ disease. * Postmenopausal women * Measurable disease as per Response Evaluation Criterion in Solid Tumors \[RECIST\] or bone-only disease * Eastern Cooperative Oncology Group \[ECOG\] 0-2 * Adequate organ and marrow function * Patient must agree to provide tumor tissue Exclusion Criteria: * Confirmed diagnosis of HER2 positive disease * Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term * Known uncontrolled or symptomatic CNS metastases * Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from completion of treatment. * Prior treatment with any CDK 4/6 inhibitor.

What they're measuring

Progression-Free Survival (PFS) as Assessed by the Investigator

Timeframe: From randomization date to date of first documentation of progression or death (up to approximately 2.5 years)

Trial details

NCT IDNCT01740427

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-02-26

Results submitted2016-10-21