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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)

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Southern California Permanente Medical Group
Bellflower, California, 90706 United States
Contact
1-800-718-1021
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 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
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 (neo)adjuvant treatment with letrozole or anastrozole with DFI ? 12-months from
completion of treatment.

- Prior treatment with any CDK 4/6 inhibitor.

NCT01740427
Pfizer
Active, not recruiting
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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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)
A Randomized, Multicenter, Double-blind Phase 3 Study Of Pd-0332991 (Oral Cdk 4/6 Inhibitor) Plus Letrozole Versus Placebo Plus Letrozole For The Treatment Of Postmenopausal Women With Er (+), Her2 (-) Breast Cancer Who Have Not Received Any Prior Systemic Anti Cancer Treatment For Advanced Disease
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.
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: PD-0332991
    PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
  • 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: PD-0332991 + Letrozole
    PD-0332991, 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: PD-0332991
    • 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
Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Diéras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
666
November 15, 2018
February 26, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   Czechia,   France,   Germany,   Hungary,   Ireland,   Italy,   Japan,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   Taiwan,   Ukraine,   United Kingdom,   United States
Czech Republic,   New Zealand
 
NCT01740427
A5481008
2012-004601-27 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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1-800-718-1021

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