NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]

NCT02297438

CompletedPhase 3

Sponsor: Pfizer

Conditions: Breast Neoplasms

Interventions: Palbociclib, Letrozole, Placebo, Letrozole

Countries: China, Hong Kong, Singapore, Taiwan, Thailand

The study is designed to compare the clinical benefit following treatment with letrozole in combination with Palbociclib versus letrozole in combination with placebo in Asian 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 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Adult Asian 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 \[ECOG\] 0-1
* 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 neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment
* Prior treatment with any CDK 4/6 inhibitor

Locations (54)

Bengbu, Anhui, China
Hefei, Anhui, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Shijiazhuang, Hebei, China
Harbin, Heilongjiang, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Changsha, Hunan, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Changchun, Jilin, China
Changchun, Jilin, China
Shenyang, Liaoning, China
Shenyang, Liaoning, China
Shanghai, Shanghai Municipality, China
Chengdu, Sichuan, China
Tianjin, Tianjin Municipality, China
Kunming, Yunnan, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Beijing, China
Beijing, China
Beijing, China
Beijing, China
+ 24 more on CT.gov