A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
Launched by PFIZER · Nov 30, 2012
Trial Information
Current as of June 01, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
FEMALE
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.
About Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Francisco, California, United States
New York, New York, United States
San Francisco, California, United States
Valencia, , Spain
Brussels, , Belgium
Adelaide, South Australia, Australia
Louisville, Kentucky, United States
Edmonton, Alberta, Canada
Calgary, Alberta, Canada
Regina, Saskatchewan, Canada
Atlanta, Georgia, United States
London, Ontario, Canada
Newport News, Virginia, United States
Parkville, Victoria, Australia
Rennes, , France
Madrid, , Spain
Hollywood, Florida, United States
Barcelona, , Spain
London, , United Kingdom
Seattle, Washington, United States
Dublin, , Ireland
Nashville, Tennessee, United States
Grand Island, Nebraska, United States
Washington, District Of Columbia, United States
Bethesda, Maryland, United States
Morgantown, West Virginia, United States
Pembroke Pines, Florida, United States
Portland, Oregon, United States
Madison, Wisconsin, United States
Los Angeles, California, United States
Ann Arbor, Michigan, United States
Villejuif, , France
Fullerton, California, United States
Atlanta, Georgia, United States
Barcelona, , Spain
Atlanta, Georgia, United States
Norfolk, Virginia, United States
Baltimore, Maryland, United States
Henderson, Nevada, United States
Madrid, , Spain
London, , United Kingdom
Woolloongabba, Queensland, Australia
Hollywood, Florida, United States
Portland, Oregon, United States
Ringwood East, Victoria, Australia
Dijon, , France
Nashville, Tennessee, United States
Villejuif, , France
Nice Cedex 2, , France
Houston, Texas, United States
Bellflower, California, United States
Santa Maria, California, United States
Atlanta, Georgia, United States
La Laguna, Santa Cruz De Tenerife, Spain
Terrassa, Barcelona, Spain
Lleida, , Spain
London, , United Kingdom
Nagoya, Aichi, Japan
Kashiwa, Chiba, Japan
Sapporo, Hokkaido, Japan
Chuo Ku, Tokyo, Japan
Mount Kisco, New York, United States
Waterford, , Ireland
Waratah, New South Wales, Australia
Sevilla, , Spain
Los Angeles, California, United States
Los Angeles, California, United States
Sevilla, , Spain
Hamburg, , Germany
Portland, Oregon, United States
Marietta, Georgia, United States
Osaka, , Japan
Kumamoto, , Japan
Badalona, Barcelona, Spain
Atlanta, Georgia, United States
Jaen, , Spain
Las Vegas, Nevada, United States
Portland, Oregon, United States
Madrid, , Spain
Chiba, , Japan
Barcelona, , Spain
Brussel, , Belgium
Leuven, , Belgium
Roma, , Italy
Caen Cedex 5, , France
Manchester, , United Kingdom
Epping, Victoria, Australia
Saint Louis Park, Minnesota, United States
Shepparton, Victoria, Australia
San Diego, California, United States
Orlando, Florida, United States
Surrey, British Columbia, Canada
Iwate, , Japan
Toronto, Ontario, Canada
Glendale, California, United States
Los Angeles, California, United States
Gallatin, Tennessee, United States
Fort Worth, Texas, United States
Virginia Beach, Virginia, United States
Mainz, , Germany
Richmond, Victoria, Australia
Dublin, , Ireland
Los Angeles, California, United States
Los Angeles, California, United States
Dallas, Texas, United States
Dallas, Texas, United States
Muenchen, , Germany
Cork, , Ireland
Goyang Si, Gyeonggi Do, Korea, Republic Of
Toronto, Ontario, Canada
Fukuoka, , Japan
Montreal, Quebec, Canada
Ryazan, , Russian Federation
Murdoch, Western Australia, Australia
Avellino, , Italy
Pisa, , Italy
Sora (Fr), , Italy
Kagoshima, , Japan
Niigata, , Japan
Palma De Mallorca, Islas Baleares, Spain
Alcorcon, Madrid, Spain
New Haven, Connecticut, United States
Dickson, Tennessee, United States
Galway, , Ireland
Los Angeles, California, United States
Beverly Hills, California, United States
Port Macquarie, New South Wales, Australia
Saint Louis, Missouri, United States
Darlinghurst, New South Wales, Australia
Dublin, , Ireland
Edinburgh, Scotland, United Kingdom
Portland, Oregon, United States
Montreal, Quebec, Canada
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Madison, Wisconsin, United States
Badajoz, , Spain
Taipei City, , Taiwan
Winchester, Virginia, United States
Vancouver, British Columbia, Canada
Portland, Oregon, United States
Matsuyama City, Ehime, Japan
Dublin 4, , Ireland
Madrid, , Spain
Los Angeles, California, United States
Grand Junction, Colorado, United States
Corinth, Mississippi, United States
Toronto, Ontario, Canada
Kumamoto, , Japan
Kita Adachi Gun, Saitama, Japan
Hiroshima, , Japan
Shelbyville, Tennessee, 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
Palo Alto, California, United States
Pasadena, California, United States
Redondo Beach, California, United States
San Francisco, California, United States
San Luis Obispo, California, United States
Santa Monica, California, United States
Santa Monica, California, United States
West Hills, California, United States
Westlake Village, California, United States
Norwalk, Connecticut, United States
Deerfield Beach, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Pembroke Pines, Florida, United States
Pembroke Pines, Florida, United States
Plantation, Florida, United States
Saint Augustine, Florida, United States
Coeur D'alene, Idaho, United States
Post Falls, Idaho, United States
Chicago, Illinois, United States
Danville, Illinois, United States
Effingham, Illinois, United States
Evanston, Illinois, United States
Mattoon, Illinois, United States
Skokie, Illinois, United States
Urbana, Illinois, United States
Louisville, Kentucky, United States
Southaven, Mississippi, United States
Ballwin, Missouri, United States
Saint Louis, Missouri, United States
Saint Louis, Missouri, United States
Grand Island, Nebraska, United States
Hastings, Nebraska, United States
Las Vegas, Nevada, United States
Brewster, New York, United States
Mount Kisco, New York, United States
Stony Brook, New York, United States
Portland, Oregon, United States
Franklin, Tennessee, United States
Germantown, Tennessee, United States
Hermitage, Tennessee, United States
Lebanon, Tennessee, United States
Memphis, Tennessee, United States
Murfreesboro, Tennessee, United States
Nashville, Tennessee, United States
Smyrna, Tennessee, United States
El Paso, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Blacksburg, Virginia, United States
Low Moor, Virginia, United States
Roanoke, Virginia, United States
Salem, Virginia, United States
Wytheville, Virginia, United States
Vancouver, Washington, United States
Vancouver, Washington, United States
Port Macquarie, New South Wales, Australia
Port Macquarie, New South Wales, Australia
Auchenflower, Queensland, Australia
Birtinya, Queensland, Australia
South Brisbane, Queensland, Australia
Bendigo, Victoria, Australia
Wilrijk, Antwerpen, Belgium
Brussels, , Belgium
Charleroi, , Belgium
Liege, , Belgium
Verviers, , Belgium
Halifax, Nova Scotia, Canada
Newmarket, Ontario, Canada
Quebec City, Quebec, Canada
Hradec Kralove, , Czechia
Anger Cedex 02, , France
La Roche Sur Yon, , France
Montpellier Cedex 5, , France
Paris Cedex 05, , France
Saint Cloud, , France
St Herblain, , France
Toulouse Cedex 9, , France
Muenchen, Bavaria, Germany
Boblingen, , Germany
Dresden, , Germany
Erlangen, , Germany
Kiel, , Germany
Magdeburg, , Germany
Munich, , Germany
Munich, , Germany
Trier, , Germany
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Gyor, , Hungary
Nyiregyhaza, , Hungary
Szeged, , Hungary
Szeged, , Hungary
Szeged, , Hungary
Limerick, , Ireland
Bologna, Bo, Italy
Meldola, Fc, Italy
Milano, Milan, Italy
Seodaemun Gu, Seoul, Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Otwock, Mazovia, Poland
Gdańsk, , Poland
Zory, , Poland
Kursk, Kursk Region, Russian Federation
Kuzmolovo, Leningrad Region, Russian Federation
Kazan, , Russian Federation
Moscow Area, , Russian Federation
Moscow, , Russian Federation
Omsk, , Russian Federation
Saint Petersburg, , Russian Federation
St Petersburg, , Russian Federation
Ufa, , Russian Federation
Ufa, , Russian Federation
Ufa, , Russian Federation
Donostia San Sebastian, , Spain
L'hospitalet De Llobregat (Barcelona), , Spain
La Coruna, , Spain
Madrid, , Spain
Taipei City, , Taiwan
Taipei, , Taiwan
Dnipro, , Ukraine
Dnipro, , Ukraine
Kharkiv, , Ukraine
Lviv, , Ukraine
Makiivka, , Ukraine
Sumy, , Ukraine
Uzhgorod, , Ukraine
Uzhgorod, , Ukraine
Zaporizhzhia, , Ukraine
Zaporizhzhya, , Ukraine
Maidstone, Kent, United Kingdom
Glasgow, Scotland, United Kingdom
Manchester, , United Kingdom
Morgantown, West Virginia, United States
Kumamoto Shi, Kumamoto, Japan
Györ, , Hungary
Stanford, California, United States
Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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