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

NCT01740427

CompletedPhase 3

Sponsor: Pfizer

Conditions: Breast Neoplasms

Interventions: PD-0332991, Letrozole, Placebo, Letrozole

Countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Hungary

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (305)

Bellflower, California, United States
Beverly Hills, California, United States
Fullerton, California, United States
Glendale, California, United States
Irvine, California, United States
Laguna Hills, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Pasadena, California, United States
Redondo Beach, California, United States
San Diego, California, United States
San Francisco, California, United States
San Francisco, California, United States
San Luis Obispo, California, United States
Santa Maria, California, United States
Santa Monica, California, United States
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