Drug · Small Molecule

Fulvestrant

CI-DRUG-00000253Explore in graph →NCIt C1379 CHEMBL1358 CIViC Approved

Regulatory

Approvals (37)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory2 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	Malignant Breast Neoplasm	Fulvestrant is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on antiestrogen therapy.	approved	Jan 8, 2018	ema
EU EMA	Malignant Breast Neoplasm	Faslodex is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.	approved	Mar 9, 2004	ema

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 16 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	138	65	67	371	37	CA, EU, US	Apr 25, 2002	1997-05
Malignant Breast Neoplasm	Approved	Phase 4	82	41	48	241	12	EU, US	Apr 25, 2002	1997-05
Malignant Ovarian Neoplasm	Phase2	Phase 2	8	6	0	17	0	—	—	2007-06
Malignant Lung Neoplasm	Phase2	Phase 2	7	5	0	15	0

Curated evidence

Clinical evidence (58)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–50 of 58 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
ESR1 Mutation1
Aromatase Inhibitor +

Clinical trials

Trials with this intervention (384)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–100 of 384 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
NCT03959891	AKT Inhibitor, Ipatasertib, With Endocrine and CDK 4/6 Inhibitor for Patients With Metastatic Breast Cancer (TAKTIC)	active not recruiting	Phase 1	77	Massachusetts General HospitalOTHER	1	Aug 19, 2026	clinicaltrials
NCT07408089	Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer(KOMODO-1)

Molecule

Record

Kind: Small Molecule
Mechanism: Estrogen receptor alpha antagonist; Estrogen receptor degrader
Targets: 1 gene
UNII: 22X328QOC4
Aliases: 7a-[9-[(4,4,5,5,5,-Pentafluoropentyl)sulphinyl]nonyl]-estra-1,3,5(10)-triene-3,17b-diol, ACT FULVESTRANT, APO-FULVESTRANT, CLIGAVYX, Faslodex, FASLODEX, Faslodex(ICI 182,780), Fulvestrant, Fulvestrant mylan, ICI 182,780, ICI 182780, ICI-182780, ICI182780, NSC-759879, TEVA-FULVESTRANT, ZD 9238, ZD-9238, ZD9238

Data updated 19 hours agoSource updated unknown

Identifiers

Codes (27)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L02BA03	FULVESTRANT
DIN (Health Canada)	02248624	FASLODEX

PIK3CA H1047R2
Everolimus + FulvestrantCombination	HER2-Positive Breast CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	2	accepted	EID1623 Case report of a 44-year-old patient with recurrent HER2-positive breast cancer. The primary tumor was HR positive; however, the metastatic tumor was HR negative. The patient was resistant to classica… (full text at CIViC) PMID 27445490 · Sun et al., 2016 · Open in CIViC	civic
Capivasertib + FulvestrantCombination	HER2 Negative Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12196 In a phase 3 trial (NCT04305496) of 708 patients with advanced HR+ HER2- breast cancer, the combination of the AKT inhibitor capivasertib and the estrogen receptor degrader fulvestrant resulted in sig… (full text at CIViC) PMID 37256976 · Turner et al., 2023 · Open in CIViC	civic

CCDC170 Fusion3
Dasatinib + FulvestrantCombination	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	3	submitted	EID11514 Protein-based assays showed that ESR1::CCDC170 fusion expressing cells had increased protein expression of HER2 and SRC, as well as increased HER2 phosphorylation. The ESR1::CCDC170 fusion, E2-E7 and … (full text at CIViC) PMID 32771039 · Li et al., 2020 · Open in CIViC	civic
Fulvestrant + LapatinibCombination	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	3	submitted	EID11513 Protein-based assays showed that ESR1::CCDC170 fusion expressing cells had increased protein expression of HER2 and SRC, as well as increased HER2 phosphorylation. The ESR1::CCDC170 fusion, E2-E7 and … (full text at CIViC) PMID 32771039 · Li et al., 2020 · Open in CIViC	civic
Fulvestrant + TamoxifenSubstitutes	Malignant Breast Neoplasm	Predictive	D	Supports Resistance	4	submitted	EID11510 The ESR1::CCDC170 fusion, E2-E7 and E2-E10 variants, were expressed in T47D luminal breast cancer cells and these cells were implanted in athymic nude mice to produce xenografts. Tamoxifen treatment r… (full text at CIViC) PMID 32771039 · Li et al., 2020 · Open in CIViC	civic

FGFR1 Amplification3
Erdafitinib + Fulvestrant + PalbociclibCombination	Malignant Breast Neoplasm	Predictive	B	Does Not Support Sensitivity Response	1	submitted	EID12485 Hormone-receptor positive HER2-negative (HR+) breast cancers can harbor alterations in fibroblast growth factor receptors (FGFRs), particularly FGFR1 amplification, which is associated with poor progn… (full text at CIViC) PMID 40627530 · Gonzalez-Ericsson et al., 2025 · Open in CIViC	civic
Fulvestrant + Palbociclib + RogaratinibCombination	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	5	accepted	EID12503 To determine if there is a causal relationship between hormonal blockade (a frequent treatment for tumors in the adjuvant setting) and FGFR1 amplification/overexpression, this study used two non-FGFR1… (full text at CIViC) PMID 33579347 · Mouron et al., 2021 · Open in CIViC	civic
Fulvestrant + LucitanibCombination	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	B	Supports Sensitivity Response	2	submitted	EID12751 In a neoadjuvant letrozole study of ER+/HER2− breast cancer (n = 72), FGFR1 amplification was enriched in endocrine-resistant tumors (9/21, 43%) versus sensitive (3/40, 7%) and intermediate (1/11, 10%… (full text at CIViC) PMID 28751448 · Formisano et al., 2017 · Open in CIViC	civic

PIK3CA C420R2
Alpelisib + FulvestrantCombination	Malignant Breast Neoplasm	Predictive	A	Supports Sensitivity Response	4	accepted	EID11275 In this randomized, phase III trial, 572 patients with HR-positive, HER2-negative advanced breast cancer who had received endocrine therapy previously underwent randomization, including 341 patients w… (full text at CIViC) PMID 31091374 · André et al., 2019 · Open in CIViC	civic
Capivasertib + FulvestrantCombination	HER2 Negative Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12183 In a phase 3 trial (NCT04305496) of 708 patients with advanced HR+ HER2- breast cancer, the combination of the AKT inhibitor capivasertib and the estrogen receptor degrader fulvestrant resulted in sig… (full text at CIViC) PMID 37256976 · Turner et al., 2023 · Open in CIViC	civic

PIK3CA E542K2
Alpelisib + FulvestrantCombination	Malignant Breast Neoplasm	Predictive	A	Supports Sensitivity Response	3	accepted	EID7315 In a phase 3 trial, 572 patients with hormone receptor positive, HER2 receptor negative advanced breast cancer who previously received endocrine therapy were allocated to alpelisib plus fulvestrant or… (full text at CIViC) PMID 31091374 · André et al., 2019 · Open in CIViC	civic
Capivasertib + FulvestrantCombination	HER2 Negative Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	2	submitted	EID12184 In a phase 3 trial (NCT04305496) of 708 patients with advanced HR+ HER2- breast cancer, the combination of the AKT inhibitor capivasertib and the estrogen receptor degrader fulvestrant resulted in sig… (full text at CIViC) PMID 37256976 · Turner et al., 2023 · Open in CIViC	civic