Fulvestrant (F)+Placebo vs F+Palbociclib First Line for Postmenopausal Hormone Receptor+ Advanced Breast Cancer

Summary

This is an international, multicentre, double-blind, controlled, randomized phase II study comparing the efficacy and safety of fulvestrant in combination with palbociclib versus fulvestrant plus placebo in postmenopausal women with HR-positive/HER2-negative metastatic breast cancer who have received ≥5 years of endocrine therapy in the adjuvant setting as treatment for early disease and remained disease free for \> 12 months following its completion or have "de novo" metastatic disease.

Timeline

Start

2016-02-17

Primary completion

2020-01-11

Completion

2023-12

Outcome

Missed primary endpoint

paper PFS-1y rates were 83.5% and 71.9% in the palbociclib/fulvestrant and placebo/fulvestrant arms, (HR 0.55, 80% CI 0.36-0.83, P = 0.064). PMID 34902765 ↗

Publications

• Tibau A, Martinez MT, Ramos M, De La Cruz-Merino L, Santaballa A, O'Connor M, Martinez-Janez N, Moreno F, Fernandez I, Virizuela JA, Alarcon J, de La Haba-Rodriguez J, Sanchez-Rovira P, Albacar CR, Bueno Muino C, Kelly C, Casas M, Bezares S, Rosell L, Albanell J. Quality of life with palbociclib plus fulvestrant versus placebo plus fulvestrant in postmenopausal women with endocrine-sensitive hormone receptor-positive and HER2-negative advanced breast cancer: patient-reported outcomes from the FLIPPER trial. Ther Adv Med Oncol. 2023 Jan 19;15:17588359221148921. doi: 10.1177/17588359221148921. eCollection 2023.
• Albanell J, Martinez MT, Ramos M, O'Connor M, de la Cruz-Merino L, Santaballa A, Martinez-Janez N, Moreno F, Fernandez I, Alarcon J, Virizuela JA, de la Haba-Rodriguez J, Sanchez-Rovira P, Gonzalez-Cortijo L, Margeli M, Sanchez-Munoz A, Anton A, Casas M, Bezares S, Rojo F. Randomized phase II study of fulvestrant plus palbociclib or placebo in endocrine-sensitive, hormone receptor-positive/HER2-advanced breast cancer: GEICAM/2014-12 (FLIPPER). Eur J Cancer. 2022 Jan;161:26-37. doi: 10.1016/j.ejca.2021.11.010. Epub 2021 Dec 11.

Drugs

Indications