Last updated on August 2018

A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer


Brief description of study

This study will look at effects the combination of palbociclib and letrozole may have on estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer tumors which have not yet been treated. Letrozole is a type of endocrine therapy called an aromatase inhibitor (AI) and is standard treatment for post-menopausal women with ER-positive/HER2-negative breast cancer.

Detailed Study Description

The FB-11 study is a Phase II, randomized, open label, four arm study to examine the biological and clinical effect of neoadjuvant letrozole with or without palbociclib in the first-line treatment of estrogen-receptor (ER) positive, HER2-negative early invasive breast cancer. The co-primary aims of this study are to to compare the changes in the proliferation marker Ki67, and to compare clinical response after 14 weeks of therapy with letrozole with or without palbociclib.

The FB-11 study initiative is a joint partnership between the NSABP Foundation, Inc. (NSABP) Department of Site and Study Management (DSSM) and United Kingdom (UK) co-investigators at the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research (ICR). Parallel protocols will be conducted in the US and Canada (FB-11), and the UK (PALLET) with joint analysis of interim and final data.

Postmenopausal women, newly diagnosed with ER-positive/HER2-negative early breast cancer, who are suitable candidates for neoadjuvant endocrine therapy will be invited to join the FB-11/PALLET trial. Approximately 306 patients will be accrued to this study. Each collaborative group will recruit at least 1/3 and no more than 2/3 of the target accrual.

Patients will be randomized to one of four treatment arms (3:2:2:2 ratio). Treatment in the first 14 weeks of neoadjuvant therapy will be:Arm A Letrozole alone; Arm B Letrozole for 2 weeks followed by letrozole + palbociclib to week 14; Arm C Palbociclib for 2 weeks followed by letrozole + palbociclib to week 14; Arm D Letrozole + palbociclib to week 14.

Letrozole will be administered orally as a 2.5mg daily tablet. Palbociclib will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week [28 day] cycle.

The end of study therapy for patients in Arm A will be completion of week 14. Patients in Arms B, C, and D will complete study therapy following 14 days of palbociclib in the final treatment cycle past 14 weeks if treatment delays have occurred.

Note: After week 14 (end of study therapy) all patients should continue letrozole until surgery. Letrozole is not considered study therapy beyond completion of week 14 for Arm A or after 14 days of palbociclib in the final treatment cycle for patients in Arms B, C, and D.

Following completion of study therapy, surgery will be scheduled for 15-18 weeks post-randomization. Post-surgical treatment will be at discretion of treating clinician, following local protocols, and not influenced by allocation of treatment within the FB-11/PALLET study.

Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).

Clinical Study Identifier: NCT02296801

Contact Investigators or Research Sites near you

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Diana Gosik, RN, BS

Long Beach Memorial Medical Center-Todd Cancer Institute
Long Beach, CA United States

Diana Gosik, RN, BS

University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
Miami, FL United States

Diana Gosik, RN, BS

Cancer Care Specialists of Central Illinois
Decatur, IL United States

Diana Gosik, RN, BS

Norton Healthcare Pavillion
Louisville, KY United States

Diana Gosik, RN, BS

Norton Cancer Institute - Suburban, Norton Medical Plaza II
Louisville, KY United States

Diana Gosik, RN, BS

Metro-Minnesota CCOP
Saint Louis Park, MN United States

Diana Gosik, RN, BS

Providence Oncology and Hematology Clinic
Portland, OR United States

Diana Gosik, RN, BS

Allegheny General Hospital
Pittsburgh, PA United States

Diana Gosik, RN, BS

University of Pittsburgh
Pittsburgh, PA United States

Diana Gosik, RN, BS

Women and Infants Hospital of Rhode Island
Providence, RI United States

Diana Gosik, RN, BS

Baylor College of Medicine
Houston, TX United States

Diana Gosik, RN, BS

Joe Arrington Cancer Research and Treatment Center
Lubbock, TX United States

Diana Gosik, RN, BS

Sentara Martha Jefferson Hospital-Phillips Family Cancer Center
Charlottesville, VA United States

Diana Gosik, RN, BS

Virginia Commonwealth University
Richmond, VA United States

Diana Gosik, RN, BS

Swedish Cancer Institute
Seattle, WA United States

Diana Gosik, RN, BS

West Virginia University
Morgantown, WV United States

Diana Gosik, RN, BS

Centre Hospitalier de l'Universite de Montreal
Montreal, QC Canada

Diana Gosik, RN, BS

Jewish General Hospital
Montreal, QC Canada

Diana Gosik, RN, BS

McGill University Health Center
Montreal, QC Canada

Diana Gosik, RN, BS

CHU de Quebec - Universite Laval
Quebec City, QC Canada

Diana Gosik, RN, BS

Milton Keynes Hospital
Milton Keynes, United Kingdom

Diana Gosik, RN, BS

Hinchingbrooke Hospital
Huntingdon, United Kingdom

Diana Gosik, RN, BS

Royal Cornwall Hospital, Treliske
Truro, United Kingdom

Diana Gosik, RN, BS

Royal Devon and Exeter Hospital
Exeter, United Kingdom

Diana Gosik, RN, BS

Royal Sussex County Hospital
Brighton, United Kingdom

Diana Gosik, RN, BS

Southend Hospital
Westcliffe-on-sea, United Kingdom

Diana Gosik, RN, BS

Darent Valley Hospital
Dartford, United Kingdom

Diana Gosik, RN, BS

Maidstone Hospital
Maidstone, United Kingdom

Diana Gosik, RN, BS

Royal Liverpool University Hospital
Liverpool, United Kingdom

Diana Gosik, RN, BS

Musgrove Park Hospital
Taunton, United Kingdom

Diana Gosik, RN, BS

Weston General Hospital
Weston-Super-Mare, United Kingdom

Diana Gosik, RN, BS

The Royal Marsden Hospital
Sutton, United Kingdom

Diana Gosik, RN, BS

Salisbury Hospital
Salisbury, United Kingdom

Diana Gosik, RN, BS

Kidderminster Hospital
Kidderminster, United Kingdom

Diana Gosik, RN, BS

Alexandra Hospital
Redditch, United Kingdom

Diana Gosik, RN, BS

Worcestershire Royal Hospital
Worcester, United Kingdom

Diana Gosik, RN, BS

Belfast City Hospital
Belfast, United Kingdom

Diana Gosik, RN, BS

Royal Bournemouth Hospital
Bournemouth, United Kingdom

Diana Gosik, RN, BS

St James' University Hospital
Leeds, United Kingdom

Diana Gosik, RN, BS

Barnet Hospital
London, United Kingdom

Diana Gosik, RN, BS

Whittington Hospital
London, United Kingdom

Diana Gosik, RN, BS

University College London Hospitals
London, United Kingdom

Diana Gosik, RN, BS

The Royal Marsden Hospital
London, United Kingdom

Diana Gosik, RN, BS

Charing Cross Hospital
London, United Kingdom

Diana Gosik, RN, BS

Nottingham University Hospitals NHS Trust, City Campus
Nottingham, United Kingdom

Diana Gosik, RN, BS

Derriford Hospital
Plymouth, United Kingdom

Diana Gosik, RN, BS

Singleton Hospital
Swansea, United Kingdom

Diana Gosik, RN, BS

Norton Cancer Institute - Brownsboro Medical Plaza I
Louisville, KY United States

Diana Gosik, RN, BS

Hope Women's Cancer Centers
Asheville, NC United States

Diana Gosik, RN, BS

Pinnacle Health Ortenzio Cancer Center
Mechanicsburg, PA United States