NCT03447132: SAFIA

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

Completed Phase 3 Last updated 10 March 2023

What this trial tests

Phase 3 trial testing Fulvestrant 500mg in Breast Neoplasm Female in 354 participants. Completed in 20 July 2021.

Timeline

20 December 2017

Primary endpoint
12 April 2021

20 July 2021

Quick facts

Lead sponsor	International Cancer Research Group, United Arab Emirates
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	354
Start date	20 December 2017
Primary completion	12 April 2021
Estimated completion	20 July 2021
Sites	14 locations across Tunisia, Jordan, Saudi Arabia, United Arab Emirates, Morocco, Lebanon, Algeria, Egypt

Drugs / interventions tested

• Fulvestrant 500mg — full drug profile →
• Palbociclib 125mg (palbociclib-125mg) — full drug profile →
• Goserelin 3.6 MG — full drug profile →
• Placebos — full drug profile →

Conditions studied

• Breast Neoplasm Female — all drugs for Breast Neoplasm Female →

Sponsor

International Cancer Research Group, United Arab Emirates

Who can join

18 and older, female only, with Breast Neoplasm Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Updates on the CDK4/6 Inhibitory Strategy and Combinations in Breast Cancer.
   Sobhani N, D'Angelo A, Pittacolo M, Roviello G, et al · · 2019 · cited 117× · PMID 30959874 · DOI 10.3390/cells8040321
2. Mechanisms of resistance in estrogen receptor positive breast cancer: overcoming resistance to tamoxifen/aromatase inhibitors.
   Mills JN, Rutkovsky AC, Giordano A. · · 2018 · cited 99× · PMID 29719270 · DOI 10.1016/j.coph.2018.04.009
3. Clinical utility of fulvestrant in the treatment of breast cancer: a report on the emerging clinical evidence.
   Rocca A, Maltoni R, Bravaccini S, Donati C, et al · · 2018 · cited 27× · PMID 30214302 · DOI 10.2147/cmar.s137772
4. Targeted Therapy in HR+ HER2- Metastatic Breast Cancer: Current Clinical Trials and Their Implications for CDK4/6 Inhibitor Therapy and beyond Treatment Options.
   Elfgen C, Bjelic-Radisic V. · · 2021 · cited 16× · PMID 34885105 · DOI 10.3390/cancers13235994
5. Neoadjuvant endocrine therapy with or without palbociclib in low-risk patients: a phase III randomized double-blind SAFIA trial.
   Alsaleh K, Al Zahwahry H, Bounedjar A, Oukkal M, et al · · 2023 · cited 15× · PMID 36680581 · DOI 10.1007/s00432-023-04588-3
6. The Evolving Pathways of the Efficacy of and Resistance to CDK4/6 Inhibitors in Breast Cancer.
   Gomes I, Abreu C, Costa L, Casimiro S. · · 2023 · cited 12× · PMID 37835528 · DOI 10.3390/cancers15194835
7. What does it take to conduct clinical trials in African countries? Insights from Morocco.
   Benhima N, El Fadli M, Essâdi I, Belbaraka R. · · 2022 · cited 8× · PMID 36072231 · DOI 10.3332/ecancer.2022.1411
8. Response to Induction Neoadjuvant Hormonal Therapy Using Upfront 21-Gene Breast Recurrence Score Assay-Results From the SAFIA Phase III Trial.
   AlSaleh K, Al Zahwahry H, Bounedjar A, Oukkal M, et al · · 2021 · cited 6× · PMID 34086481 · DOI 10.1200/go.20.00575