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. 88 recruiting · 47 active phase 3 · 689 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 101–150 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
NCT07062965	A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.	recruiting

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
Letrozole	US FDA	—	Efficacy supplement 2003-02-26 (see label)	approved	Feb 26, 2003	openfda
Letrozole	US FDA	—	Efficacy supplement 2003-01-17 (see label)	approved	Jan 17, 2003	openfda
Letrozole	US FDA	—	Efficacy supplement 2001-01-10 (see label)	approved	Jan 10, 2001	openfda
Letrozole	US FDA	Malignant Breast Neoplasm	Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.	approved	Jul 25, 1997	openfda
Letrozole	US FDA	Malignant Breast Neoplasm	Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy.	approved	Jul 25, 1997	openfda
Letrozole	US FDA	Malignant Breast Neoplasm	First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer.	approved	Jul 25, 1997	openfda
Olaparib	EU EMA	—	Ovarian cancer Lynparza is indicated as monotherapy for the: maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. Lynparza in combination with bevacizumab is indicated for the: maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability (see section 5.1). Breast cancer Lynparza is indicated as: monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1). monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1). Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy. Adenocarcinoma of the pancreas Lynparza is indicated as: monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. Prostate cancer Lynparza is indicated as: monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated (see section 5.1). Endometrial cancer Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.
Olaparib	US FDA	Hormone Receptor-Positive Breast Carcinoma	for the treatment of adult patients with deleterious or suspected deleterious gBRCA m, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.	approved	Aug 17, 2017	openfda
Palbociclib	CA Health Canada	—	Marketed in Canada as PMS-PALBOCICLIB (DIN 02552140) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 27, 2024	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as PMS-PALBOCICLIB (DIN 02552132) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 27, 2024	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as PMS-PALBOCICLIB (DIN 02552124) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 27, 2024	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as TARO-PALBOCICLIB (DIN 02547643) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 17, 2024	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as TARO-PALBOCICLIB (DIN 02547635) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 17, 2024	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as TARO-PALBOCICLIB (DIN 02547651) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 17, 2024	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as IBRANCE (DIN 02493543) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 21, 2020	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as IBRANCE (DIN 02493551) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 21, 2020	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as IBRANCE (DIN 02493535) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 21, 2020	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as IBRANCE (DIN 02453150) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jun 6, 2024	Apr 20, 2016	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as IBRANCE (DIN 02453169) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jun 6, 2024	Apr 19, 2016	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as IBRANCE (DIN 02453177) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jun 6, 2024	Apr 19, 2016	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as NAT-PALBOCICLIB (DIN 02570130) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as NAT-PALBOCICLIB (DIN 02570157) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as NAT-PALBOCICLIB (DIN 02570149) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Palbociclib	EU EMA	Malignant Breast Neoplasm	Palbociclib Viatris is indicated for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic breast cancer. in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1). In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone‑releasing hormone (LHRH) agonist.	approved	Jun 19, 2026	ema
Palbociclib	EU EMA	Malignant Breast Neoplasm	Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.	approved	Nov 9, 2016	ema
Palbociclib	US FDA	—	Efficacy supplement 2026-06-24 (see label)	approved	Jun 24, 2026	openfda
Palbociclib	US FDA	—	Efficacy supplement 2026-06-24 (see label)	approved	Jun 24, 2026	openfda
Palbociclib	US FDA	—	Efficacy supplement 2025-09-16 (see label)	approved	Sep 16, 2025	openfda
Palbociclib	US FDA	—	Efficacy supplement 2025-09-16 (see label)	approved	Sep 16, 2025	openfda
Palbociclib	US FDA	—	Efficacy supplement 2025-04-23 (see label)	approved	Apr 23, 2025	openfda
Palbociclib	US FDA	—	Efficacy supplement 2025-04-23 (see label)	approved	Apr 23, 2025	openfda
Palbociclib	US FDA	—	Efficacy supplement 2023-09-06 (see label)	approved	Sep 6, 2023	openfda
Palbociclib	US FDA	—	Efficacy supplement 2023-09-06 (see label)	approved	Sep 6, 2023	openfda
Palbociclib	US FDA	—	Efficacy supplement 2022-12-13 (see label)	approved	Dec 13, 2022	openfda
Palbociclib	US FDA	—	Efficacy supplement 2022-12-13 (see label)	approved	Dec 13, 2022	openfda
Palbociclib	US FDA	Malignant Breast Neoplasm	in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA‑authorized test, following recurrence on or after completing adjuvant endocrine therapy.	approved	Nov 1, 2019	openfda
Palbociclib	US FDA	Malignant Breast Neoplasm	for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: o an aromatase inhibitor as initial endocrine-based therapy	approved	Nov 1, 2019	openfda
Palbociclib	US FDA	Malignant Breast Neoplasm	in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2‑positive locally advanced or metastatic breast cancer following induction treatment.	approved	Nov 1, 2019	openfda
Palbociclib	US FDA	—	; or o fulvestrant in patients with disease progression following endocrine therapy.	approved	Nov 1, 2019	openfda
Palbociclib	US FDA	—	Efficacy supplement 2019-09-09 (see label)	approved	Sep 9, 2019	openfda
Palbociclib	US FDA	—	Efficacy supplement 2019-04-04 (see label)	approved	Apr 4, 2019	openfda
Palbociclib	US FDA	—	Efficacy supplement 2018-02-06 (see label)	approved	Feb 6, 2018	openfda
Palbociclib	US FDA	—	Efficacy supplement 2017-03-31 (see label)	approved	Mar 31, 2017	openfda
Palbociclib	US FDA	—	Efficacy supplement 2016-02-19 (see label)	approved	Feb 19, 2016	openfda
Palbociclib	US FDA	—	; or o fulvestrant in patients with disease progression following endocrine therapy.	approved	Feb 3, 2015	openfda
Palbociclib	US FDA	Malignant Breast Neoplasm	in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2 positive locally advanced or metastatic breast cancer following induction treatment.	approved	Feb 3, 2015	openfda
Palbociclib	US FDA	Malignant Breast Neoplasm	for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: o an aromatase inhibitor as initial endocrine-based therapy	approved	Feb 3, 2015	openfda
Palbociclib	US FDA	Malignant Breast Neoplasm	in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-authorized test, following recurrence on or after completing adjuvant endocrine therapy.	approved	Feb 3, 2015	openfda
Ribociclib	EU EMA	Malignant Breast Neoplasm	Early breast cancer Kisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence (see section 5.1 for selection criteria). In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or metastatic breast cancer Kisqali is indicated for the treatment of women with HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.	approved	Aug 22, 2017	ema
Ribociclib	US FDA	Malignant Breast Neoplasm	Early Breast Cancer KISQALI is indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.	approved	Mar 13, 2017	openfda

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source

US FDA

—

Efficacy supplement 2003-02-26 (see label)

approved

Feb 26, 2003

US FDA

—

Efficacy supplement 2003-01-17 (see label)

approved

Jan 17, 2003

US FDA

—

Efficacy supplement 2001-01-10 (see label)

approved

Jan 10, 2001

US FDA

Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.

approved

Jul 25, 1997

US FDA

Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy.

approved

Jul 25, 1997

US FDA

First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer.

approved

Jul 25, 1997