Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant

Summary

This is a multicenter, international, double-blind randomized Phase III study to evaluate the pathological complete response (pCR) according to Chevalier classification between Fulvestrant® and the combination of Fulvestrant® plus Palbociclib as neoadjuvant therapy of hormone-sensitive patients with operable luminal breast cancer. Eligible patients will be assessed upfront using the OncotypeDX® molecular test (Recurrence Score \<31).

Timeline

Start

2017-12-20

Primary completion

2021-04-12

Completion

2021-07-20

Publications

• Results Alsaleh K, Al Zahwahry H, Bounedjar A, Oukkal M, Saadeddine A, Mahfouf H, Bouzid K, Bensalem A, Filali T, Abdel-Razeq H, Larbaoui B, Kandil A, Abulkhair O, Al Foheidi M, Ghosn M, Rasool H, Boussen H, Mezlini A, Haddaoui A, Ayari J, Al Ghamdi M, Errihani H, Abdel-Aziz N, Arafah M, Dabouz F, Bahadoor M, Kullab S, Nabholtz JM; King Saud University, Riyadh, Kingdom of Saudi Arabia, and the International Cancer Research Group (ICRG), Sharjah, Unites Arab Emirates. Neoadjuvant endocrine therapy with or without palbociclib in low-risk patients: a phase III randomized double-blind SAFIA trial. J Cancer Res Clin Oncol. 2023 Aug;149(9):6171-6179. doi: 10.1007/s00432-023-04588-3. Epub 2023 Jan 21.

Drugs

Indications