Estrogen receptor (ER)

Clinical trials

Active trials (177)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 87 recruiting · 47 active phase 3 · 688 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–50 of 177 active studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT05646862	A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

Literature

Linked publications (6)

Publications linked to the scope gene(s) through PubMed entity edges; 25 per page, newest first.

pubmedPublishedShowing 1–6 of 6 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial.
· J Clin Oncol · 2022 · PMID 35584336 · validated civic_curation pubmed
The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study.
· Lancet Oncol · 2015 · PMID 25524798 · validated civic_curation pubmed
The Genetic Landscape and Clonal Evolution of Breast Cancer Resistance to Palbociclib plus Fulvestrant in the PALOMA-3 Trial.
· Cancer Discov · 2018 · PMID 30206110 · validated civic_curation pubmed

ESR1 Mutation + PIK3CA Mutation + RB1 MutationPIK3CA RB1 ESR11
Fulvestrant + PalbociclibCombination	Malignant Breast Neoplasm	Predictive	B	Supports Resistance	3	accepted	EID12045 In this phase III trial (PALOMA-3), patients with ER+, HER2- advanced breast cancer were treated with CDK4/6 inhibitors. Patients were randomized to receive palbociclib plus fulvestrant (P+F) or place… (full text at CIViC) PMID 30206110 · O'Leary et al., 2018 · Open in CIViC	civic

ESR1 Mutation + PIK3CA Mutation + RB1 MutationPIK3CA RB1 ESR11

Fulvestrant + PalbociclibCombination

Predictive

Supports Resistance

accepted

EID12045

In this phase III trial (PALOMA-3), patients with ER+, HER2- advanced breast cancer were treated with CDK4/6 inhibitors. Patients were randomized to receive palbociclib plus fulvestrant (P+F) or place… (full text at CIViC)

PMID 30206110 · O'Leary et al., 2018 · Open in CIViC

ESR1 L536Q2
Hormone Therapy	Malignant Breast Neoplasm	Predictive	D	Supports Resistance	3	accepted	EID242 MCF7 cell lines harboring the L536Q mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy. PMID 24185512 · Toy et al., 2013 · Open in CIViC	civic
Fulvestrant + TamoxifenSubstitutes	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	5	accepted	EID290 Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the L536Q ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC) PMID 24185510 · Robinson et al., 2013 · Open in CIViC	civic

ESR1 L536Q2

Predictive

Supports Resistance

accepted

EID242

MCF7 cell lines harboring the L536Q mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy.

PMID 24185512 · Toy et al., 2013 · Open in CIViC

Fulvestrant + TamoxifenSubstitutes

Predictive

Supports Sensitivity Response

accepted

EID290

Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the L536Q ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC)

PMID 24185510 · Robinson et al., 2013 · Open in CIViC

ESR1 D538G3
Hormone Therapy	Malignant Breast Neoplasm	Predictive	D	Supports Resistance	3	accepted	EID243 MCF7 cell lines harboring the D538G mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy. PMID 24185512 · Toy et al., 2013 · Open in CIViC	civic
Letrozole + PalbociclibCombination	Malignant Breast Neoplasm	Predictive	C	Does Not Support Sensitivity Response	2	accepted	EID4814 In a study of 16 patients with metastatic breast cancer (NCT02142868) treated with palbociclib in combination with letrozole, patients with ESR1 mutations (5/16), including ESR1 D538G (n=2), detected … (full text at CIViC) PMID 28978004 · Gyanchandani et al., 2017 · Open in CIViC	civic
Fulvestrant + TamoxifenSubstitutes	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	5	accepted	EID291 Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the N538G ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC) PMID 24185510 · Robinson et al., 2013 · Open in CIViC	civic

ESR1 D538G3

Predictive

Supports Resistance

accepted

EID243

MCF7 cell lines harboring the D538G mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy.

PMID 24185512 · Toy et al., 2013 · Open in CIViC

Letrozole + PalbociclibCombination

Predictive

Does Not Support Sensitivity Response

accepted

EID4814

In a study of 16 patients with metastatic breast cancer (NCT02142868) treated with palbociclib in combination with letrozole, patients with ESR1 mutations (5/16), including ESR1 D538G (n=2), detected … (full text at CIViC)

PMID 28978004 · Gyanchandani et al., 2017 · Open in CIViC

Fulvestrant + TamoxifenSubstitutes

Predictive

Supports Sensitivity Response

accepted

EID291

Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the N538G ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC)

PMID 24185510 · Robinson et al., 2013 · Open in CIViC

ESR1 Y537C2
Hormone Therapy	Malignant Breast Neoplasm	Predictive	D	Supports Resistance	3	accepted	EID244 MCF7 cell lines harboring the Y537C mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy. PMID 24185512 · Toy et al., 2013 · Open in CIViC	civic
Fulvestrant + TamoxifenSubstitutes	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	5	accepted	EID292 Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the Y537C ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC) PMID 24185510 · Robinson et al., 2013 · Open in CIViC	civic

ESR1 Y537C2

Predictive

Supports Resistance

accepted

EID244

MCF7 cell lines harboring the Y537C mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy.

PMID 24185512 · Toy et al., 2013 · Open in CIViC

Fulvestrant + TamoxifenSubstitutes

Predictive

Supports Sensitivity Response

accepted

EID292

Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the Y537C ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC)

PMID 24185510 · Robinson et al., 2013 · Open in CIViC

ESR1 Y537N2
Hormone Therapy	Malignant Breast Neoplasm	Predictive	D	Supports Resistance	3	accepted	EID245 MCF7 cell lines harboring the Y537N mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy. PMID 24185512 · Toy et al., 2013 · Open in CIViC	civic
Fulvestrant + TamoxifenSubstitutes	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	5	accepted	EID293 Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the Y537N ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC) PMID 24185510 · Robinson et al., 2013 · Open in CIViC	civic

ESR1 Y537N2

Predictive

Supports Resistance

accepted

EID245

MCF7 cell lines harboring the Y537N mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy.

PMID 24185512 · Toy et al., 2013 · Open in CIViC

Fulvestrant + TamoxifenSubstitutes

Predictive

Supports Sensitivity Response

accepted

EID293

Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the Y537N ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC)

PMID 24185510 · Robinson et al., 2013 · Open in CIViC

ESR1 Y537S2
Hormone Therapy	Malignant Breast Neoplasm	Predictive	D	Supports Resistance	3	accepted	EID246 MCF7 cell lines harboring the L537S mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy. PMID 24185512 · Toy et al., 2013 · Open in CIViC	civic
Fulvestrant + TamoxifenSubstitutes	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	5	accepted	EID294 Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the Y537S ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC) PMID 24185510 · Robinson et al., 2013 · Open in CIViC	civic

ESR1 Y537S2

Predictive

Supports Resistance

accepted

EID246

MCF7 cell lines harboring the L537S mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy.

PMID 24185512 · Toy et al., 2013 · Open in CIViC

Fulvestrant + TamoxifenSubstitutes

Predictive

Supports Sensitivity Response

accepted

EID294

Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the Y537S ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC)

PMID 24185510 · Robinson et al., 2013 · Open in CIViC

ESR1 Overexpression1
Letrozole + PalbociclibCombination	Malignant Breast Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID1541 A phase 2 clinical trial evaluated 165 patients with oestrogen receptor positive and HER2-negative breast cancer such that 84 patients received combination therapy of palbociclib plus letrozole and 81… (full text at CIViC) PMID 25524798 · Finn et al., 2015 · Open in CIViC	civic

ESR1 Overexpression1

Letrozole + PalbociclibCombination

Predictive

Supports Sensitivity Response

accepted

EID1541

A phase 2 clinical trial evaluated 165 patients with oestrogen receptor positive and HER2-negative breast cancer such that 84 patients received combination therapy of palbociclib plus letrozole and 81… (full text at CIViC)

PMID 25524798 · Finn et al., 2015 · Open in CIViC

ESR1 S463P1
Aromatase Inhibitor	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	D	Supports Resistance	2	accepted	EID1727 ESR1 S463P variants were observed after extensive treatment with hormonal therapy (aromatase inhibition). Expression of the S463P mutant was found to induce modest activity in the absence of hormone. … (full text at CIViC) PMID 24185512 · Toy et al., 2013 · Open in CIViC	civic

ESR1 S463P1

Aromatase Inhibitor

Estrogen Receptor-positive Breast CancerUNRESOLVED

Predictive

Supports Resistance

accepted

EID1727

ESR1 S463P variants were observed after extensive treatment with hormonal therapy (aromatase inhibition). Expression of the S463P mutant was found to induce modest activity in the absence of hormone. … (full text at CIViC)

PMID 24185512 · Toy et al., 2013 · Open in CIViC

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Fulvestrant	US FDA	Malignant Breast Neoplasm	HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. (1)	approved	Apr 25, 2002	openfda
Fulvestrant	US FDA	Malignant Breast Neoplasm	Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. (1)	approved	Apr 25, 2002	openfda
Imlunestrant	US FDA	Malignant Breast Neoplasm	INLURIYO is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 ( ESR1 )-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. INLURIYO TM is an estrogen receptor antagonist indicated for: treatment of adults with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy ( 1 )	approved	Sep 25, 2025	openfda
Inavolisib	US FDA	Malignant Breast Neoplasm	ITOVEBI, in combination with palbociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy [see Clinical Studies (14.1) ] . ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. ( 1 , 14.1 )	approved	Oct 10, 2024	openfda
Lapatinib	US FDA	Malignant Breast Neoplasm	TYKERB ® is indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. TYKERB is a kinase inhibitor indicated in combination with: ( 1 ) capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.	approved	Mar 13, 2007	openfda
Letrozole	CA Health Canada	—	Marketed in Canada as M-LETROZOLE (DIN 02549972) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 25, 2025	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as AG-LETROZOLE TABLETS (DIN 02543419) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 20, 2024	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as JAMP LETROZOLE TABLETS (DIN 02541912) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 20, 2024	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as LETROZOLE (DIN 02524244) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 18, 2022	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as NRA-LETROZOLE (DIN 02520486) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 25, 2022	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as AG-LETROZOLE (DIN 02374439) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Aug 3, 2026	Feb 3, 2022	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as MINT-LETROZOLE (DIN 02508109) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 20, 2021	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as LETROZOLE (DIN 02504472) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 19, 2021	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as CCP-LETROZOLE (DIN 02459884) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 3, 2023	Jul 24, 2017	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as VAN-LETROZOLE (DIN 02428156) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 7, 2019	Jun 8, 2015	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as NAT-LETROZOLE (DIN 02421585) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 3, 2015	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as RIVA-LETROZOLE (DIN 02398656) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 11, 2014	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as TEVA-LETROZOLE (DIN 02343657) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 8, 2013	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as ZINDA-LETROZOLE (DIN 02378213) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Jul 17, 2018	Jun 18, 2013	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as AURO-LETROZOLE (DIN 02404400) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Apr 24, 2015	Jun 12, 2013	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as LETROZOLE (DIN 02402025) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 14, 2013	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as BIO-LETROZOLE (DIN 02392496) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 12, 2013	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as MAR-LETROZOLE (DIN 02373424) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 8, 2013	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as APO-LETROZOLE (DIN 02358514) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 11, 2012	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as TARO-LETROZOLE (DIN 02372282) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Nov 22, 2022	Oct 4, 2011	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as JAMP-LETROZOLE (DIN 02373009) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Aug 3, 2026	Sep 30, 2011	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as MYL-LETROZOLE (DIN 02372169) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jun 28, 2016	Sep 8, 2011	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as LETROZOLE (DIN 02348896) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jun 25, 2014	Aug 29, 2011	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as ACH-LETROZOLE (DIN 02338459) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 3, 2010	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as MED-LETROZOLE (DIN 02322315) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince May 25, 2018	Apr 28, 2010	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as PMS-LETROZOLE (DIN 02309114) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 28, 2010	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as LETROZOLE (DIN 02348969) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jun 18, 2018	Apr 28, 2010	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as LETROZOLE (DIN 02347997) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Dec 10, 2013	Apr 28, 2010	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as SANDOZ LETROZOLE (DIN 02344815) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 27, 2010	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as FEMARA (DIN 02231384) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 18, 1997	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as STASON-LETROZOLE (DIN 02431335) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jun 27, 2018	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as CO LETROZOLE (DIN 02352052) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Sep 1, 2017	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as LETROZOLE SUN (DIN 02375273) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jul 11, 2022	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as LETROZOLE TABLETS (DIN 02381958) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Mar 10, 2023	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as PHL-LETROZOLE (DIN 02316366) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Sep 13, 2017	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as DOM-LETROZOLE (DIN 02316374) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince May 30, 2025	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as ACCEL-LETROZOLE TABLETS USP (DIN 02406330) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince May 19, 2017	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as MYLAN-LETROZOLE (DIN 02322544) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Nov 2, 2016	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as IPG-LETROZOLE (DIN 02370794) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as PRIVA-LETROZOLE (DIN 02504286) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jul 29, 2022	—	health-canada-dpd
Letrozole	US FDA	—	Efficacy supplement 2010-04-30 (see label)	approved	Apr 30, 2010	openfda
Letrozole	US FDA	—	Efficacy supplement 2010-03-02 (see label)	approved	Mar 2, 2010	openfda
Letrozole	US FDA	—	Efficacy supplement 2010-03-02 (see label)	approved	Mar 2, 2010	openfda
Letrozole	US FDA	—	Efficacy supplement 2005-12-28 (see label)	approved	Dec 28, 2005	openfda
Letrozole	US FDA	—	Efficacy supplement 2004-10-29 (see label)	approved	Oct 29, 2004	openfda

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source

Fulvestrant

US FDA

HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. (1)

approved

Apr 25, 2002

Fulvestrant

US FDA

Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. (1)

approved

Apr 25, 2002

Imlunestrant

US FDA

INLURIYO is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 ( ESR1 )-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. INLURIYO TM is an estrogen receptor antagonist indicated for: treatment of adults with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy ( 1 )

approved

Sep 25, 2025

Inavolisib

US FDA

ITOVEBI, in combination with palbociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy [see Clinical Studies (14.1) ] . ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. ( 1 , 14.1 )

approved

Oct 10, 2024

Lapatinib

US FDA