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Befejeződött3. fázis

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]

Key facts

Where
Beijing, Bengbu, Changchun, Changsha, Chengdu, Chongqing, Fuzhou, Guangzhou, Hangzhou, Harbin, Hefei, Kunming, Nanjing, Shanghai, Shenyang, Shijiazhuang, Tianjin, Wuhan és Zhengzhou, KínaSee the 33 sites
Phase
3. fázis

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Where in Kína

  • 307 Hospital of PLABeijing, KínaNo longer taking part
  • Beijing Cancer HospitalBeijing, KínaNo longer taking part
  • Cancer Institute and Hospital, Chinese Academy of Medical SciencesBeijing, KínaNo longer taking part
  • Chinese PLA General Hospital/OncologyBeijing, KínaNo longer taking part
  • Peking University Third Hospital/Department of OncologyBeijing, KínaNo longer taking part
  • The First Affiliated Hospital of Bengbu Medical College/Medical Oncology DepartmentBengbu, KínaNo longer taking part
  • Jilin Provincial Cancer HospitalChangchun, KínaNo longer taking part
  • The First Hospital of Jilin UniversityChangchun, KínaNo longer taking part
  • Hunan Provincial Tumor Hospital/Breast Internal Medicine DepartmentChangsha, KínaNo longer taking part
  • The Second Xiangya Hospital of Central South UniversityChangsha, KínaNo longer taking part
  • West China Hospital of Sichuan UniversityChengdu, KínaNo longer taking part
  • Oncology Department, the Second Affiliated Hospital of Third Military Medical University, PLAChongqing, KínaNo longer taking part
  • Fujian Medical University Union Hospital/Medical Oncology DepartmentFuzhou, KínaNo longer taking part
  • Breast Tumor Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityGuangzhou, KínaNo longer taking part
  • Guangdong Provincial People's HospitalGuangzhou, KínaNo longer taking part
  • Sun Yat-sen University Cancer CenterGuangzhou, KínaNo longer taking part
  • Zhongshan Ophthalmic Center,Sun Yat-Sen UniversityGuangzhou, KínaNo longer taking part
  • Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for OncologyHangzhou, KínaNo longer taking part
  • The First Affiliated Hospital of College of Medicine,Zhejiang UniversityHangzhou, KínaNo longer taking part
  • Zhejiang Cancer HospitalHangzhou, KínaNo longer taking part
  • Harbin Medical University Cancer Hospital/Oncology DepartmentHarbin, KínaNo longer taking part
  • The First Affiliated Hospital of Anhui Medical UniversityHefei, KínaNo longer taking part
  • The Tumor Hospital of Yunnan ProvinceKunming, KínaNo longer taking part
  • Jiangsu Cancer HospitalNanjing, KínaNo longer taking part
  • Jiangsu Province HospitalNanjing, KínaNo longer taking part
  • Fudan University Shanghai Cancer CenterShanghai, KínaNo longer taking part
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghai, KínaNo longer taking part
  • Liaoning Province Cancer HospitalShenyang, KínaNo longer taking part
  • The First Hospital of China Medical University/Oncology DepartmentShenyang, KínaNo longer taking part
  • Fourth Hospital of Hebei Medical UniversityShijiazhuang, KínaNo longer taking part
  • Tianjin Cancer Hospital/Breast cancer departmentTianjin, KínaNo longer taking part
  • Hubei Cancer HospitalWuhan, KínaNo longer taking part
  • Henan Cancer HospitalZhengzhou, KínaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Pfizer
Trial code
NCT02297438
Record updated
2026. november 5.
Original description
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.Read full original descriptionShow less

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND PHASE 3 STUDY OF PALBOCICLIB (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF PREVIOUSLY UNTREATED ASIAN POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) ADVANCED BREAST CANCER

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.

Inclusion: 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: 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; 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.

ClinicalTrials.gov NCT02297438