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Table 2 Fulvestrant ongoing clinical studies

From: Emerging therapies for breast cancer

CT.gov No.

Name

Investigational Agent

Trial

NCT02646735

FRIEND

Fulvestrant

A Randomized, Open label, Parallel-group, Multi-Centre, Pilot study to compare the Efficacy and Tolerability of Fulvestrant 500mg with Exemestane as First line endocrine therapy for Postmenopausal Hormone Receptor Positive HER2 negative Advanced Breast Cancer patients relapse after adjuvant Non-steroidal Aromatase Inhibitors

Exemestane

NCT02072512

PROOF

Goserelin

A Phase III, Randomized, Open label, Parallel-group, Multi-Centre study to compare the Efficacy of Goserelin combined with Fulvestrant 500 mg and Anastrozole 1mg as First line endocrine therapy for Pre- or Peri-menopausal patients having Hormone Receptor Positive Advanced Breast Cancer After or During Adjuvant Endocrine therapy

Fulvestrant

Anastrozole

NCT02107703

MONARCH 2

Fulvestrant

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

Abemaciclib

NCT02422615

MONALEESA 3

Ribociclib

A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment

Fulvestrant

NCT02690480

FLIPPER

Fulvestrant

A Randomized, Double-blind, Parallel-group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant 500mg With Placebo and Fulvestrant 500mg in Combination With Palbociclib as First Line Treatment for Postmenopausal Women With Hormone Receptor-positive Metastatic Breast Cancer, Who Have Completed at Least 5 Years of Adjuvant Endocrine Therapy and Remained Disease Free for More Than 12 Months Following Its Completion or Have “de Novo” Metastatic Disease

Palbociclib

NCT02028507

PEARL

Palbociclib

Phase III Study of Palbociclib in Combination With Endocrine Therapy (Exemestane or Fulvestrant) Versus Chemotherapy (Capecitabine) in Hormonal Receptor (HR) Positive/HER2 Negative Metastatic Breast Cancer (MBC) Patients With Resistance to Non-steroidal Aromatase Inhibitors

Exemestane

Fulvestrant

Capecitabine

NCT02491983

PARSIFAL

Palbociclib

A Randomized, Multicenter, Open-label, Phase II Trial to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With HER2 Negative, ER+ Metastatic Breast Cancer

Fulvestrant

Letrozole

NCT02536742

PYTHIA

Palbociclib

A Phase II Study of Palbociclib Plus Fulvestrant Versus Placebo Plus Fulvestrant for Pretreated Patients With ER+/HER2- Metastatic Breast Cancer

Fulvestrant

NCT01633060

BELLE 3

BKM120

A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment

Fulvestrant

NCT02340221

SANDPIPER

Taselisib

A Phase III, Double-Blind, Placebo Controlled, Randomized Study of Taselisib plus Fulvestrant vs Placebo plus Fulvestrant in Postmenopausal women with Estrogen Receptor-Positive and HER2-Negative Locally Advanced or Metastatic Breast Cancer who have Disease Recurrence or Progression during or after Aromatase Inhibitor Therapy

Fulvestrant

NCT02216786

MANTA

Fulvestrant

A Randomized Phase II Study of Fulvestrant in Combination With the Dual mTOR Inhibitor AZD2014 or Everolimus or Fulvestrant Alone in Estrogen Receptor-positive Advanced or Metastatic Breast Cancer ()

AZD2014

Everolimus