Drug · Small Molecule

Tamoxifen

CI-DRUG-00000572Explore in graph →NCIt C62078 CHEMBL83 CIViC Approved

Regulatory

Approvals (31)

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

openfdaRegulatory5 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2018-09-25 (see label)	approved	Sep 25, 2018	openfda
US FDA	Malignant Breast Neoplasm	For treatment of adult patients with estrogen receptor-positive metastatic breast cancer	approved	Oct 29, 2005	openfda
US FDA	Malignant Breast Neoplasm	For adjuvant treatment of adult patients with early stage estrogen receptor- positive breast cancer	approved	Oct 29, 2005	openfda
US FDA	Malignant Breast Neoplasm	To reduce the incidence of breast cancer in adult women at high risk	approved	Oct 29, 2005

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 days 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	55	29	116	287	31	CA, US	Dec 31, 1989	1987-09
Malignant Breast Neoplasm	Approved	Phase 4	35	19	93	201	3	US	Oct 29, 2005	1987-09
Malignant Ovarian Neoplasm	Phase3	Phase 3	1	0	3	10	0	—	—	1996-09
Malignant Prostate Neoplasm	Phase3	Phase 3	1	0	1	4	0

Curated evidence

Clinical evidence (23)

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

civicCuratedShowing 1–23 of 23 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
AGR2 EXPRESSION1
Tamoxifen	Malignant Breast Neoplasm

Clinical trials

Trials with this intervention (306)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 301–306 of 306 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
NCT00077168	Adjuvant Radiation Therapy Compared With Observation After Surgery in Treating Women With Estrogen Receptor Positive or Progesterone Receptor Positive Ductal Carcinoma In Situ of the Breast Who Are Receiving Tamoxifen or Anastrozole	unknown	Phase 2	2,000	Institute of Cancer Research, United KingdomOTHER	1	Feb 9, 2009	clinicaltrials
NCT00228930	Tamoxifen Pharmacogenetics and Clinical Effects

Molecule

Record

Kind: Small Molecule
Mechanism: Estrogen receptor alpha modulator
Targets: 1 gene
UNII: 7FRV7310N6
Aliases: 1-p-beta-dimethylamino-ethoxyphenyl-trans-1,2-diphenylbut-1-ene, APO-TAMOX, DOM-TAMOXIFEN, ICI-47699, Mammaton, MYLAN-TAMOXIFEN, NOLVADEX, NOLVADEX-D, Novaldex, NSC-727681, PENTA-TAMOXIFEN, PMS-TAMOXIFEN, SOLTAMOX, TAMOFEN, TAMONE, Tamoplex, TAMOPLEX, Tamoxifen, Tamoxifen Citrate, TAMOXIFEN CITRATE, Tamoxifene, TAMOXIFENE -, Tamoxifeno, TEVA-TAMOXIFEN, TMX

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (53)

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

System	Code	Label
ATC (WHO)	L02BA01	TAMOXIFEN
DIN (Health Canada)	00810444	TAMONE TAB 10MG

CCND1 Amplification1
Tamoxifen	Malignant Breast Neoplasm	Predictive	B	Does Not Support Resistance	3	accepted	EID858 In this retrospective analysis, CCND1 amplification was analyzed in 442 patients. No interaction with treatment was observed. PMID 24367492 · Keilty et al., 2013 · Open in CIViC	civic

CCND1 Amplification1

Tamoxifen

Malignant Breast Neoplasm

Predictive

Does Not Support Resistance

accepted

EID858

In this retrospective analysis, CCND1 amplification was analyzed in 442 patients. No interaction with treatment was observed.

PMID 24367492 · Keilty et al., 2013 · Open in CIViC

CCDC170 Fusion3
Dasatinib + TamoxifenCombination	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	4	submitted	EID11512 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
Lapatinib + TamoxifenCombination	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	4	submitted	EID11511 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