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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]

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NCT02297438

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department
Bengbu, Anhui, 233004 China
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT02297438
Pfizer
Active, not recruiting
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]

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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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]
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Breast Neoplasms
  • Drug: Palbociclib
    Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
    Other Name: PD-0332991
  • Drug: Letrozole
    Letrozole, 2.5mg, orally once daily (continuously)
  • Drug: Placebo
    Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
  • Experimental: Palbociclib + Letrozole
    Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously)
    Interventions:
    • Drug: Palbociclib
    • Drug: Letrozole
  • Active Comparator: Placebo + Letrozole
    Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).
    Interventions:
    • Drug: Placebo
    • Drug: Letrozole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
338
December 2, 2022
March 29, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China,   Hong Kong,   Singapore,   Taiwan,   Thailand
 
 
NCT02297438
A5481027
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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