Clinical trial · Interventional
Study of Tamoxifen in Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression
Phase II Study of Hormone Therapy With Tamoxifen in Patients With Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-arm, unicentric, single-stage clinical study of tamoxifen for patients with well differentiated neuroendocrine tumors and radiological progression with positive (\> 1 percent) HR (estrogen and / or progesterone) expression by IHC. It will evaluate if Tamoxifen exerts antitumor action in patients with well differentiated NET and positive for the expression of HR, estrogen and / or progesterone.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Estrogen Receptor Positive Tumor | — | UNRESOLVED | — |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
| Progesterone Receptor Positive Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tamoxifen
- description
- The participants will receive tamoxifen 20mg orally once daily with a glass of water. Each cycle will be defined for 42 days (6 weeks).
- interventionNames
- Drug: Tamoxifen
Primary outcomes (1)
- measure
- Disease control rate
- timeFrame
- at 24 weeks after initiation of tamoxifen (at the end of cycle 6 - each cycle is 28 days)
- description
- Defined by absence of radiological progression in conventional imaging examinations by RECIST 1.1. Isolated increase of biomarker (chromogranin A) or specific hormone will not be considered progression.
Secondary outcomes (5)
- measure
- Progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age greater than or equal to 18 years * Histological diagnosis of well differentiated NET (typical and atypical lung carcinoids, NET G1, NET G2 of all gastroenteropancreatic sites and pancreatic NET G3 according to WHO 2017 classification) 20 advanced / metastatic, inoperable, with no possibility of curative treatment * Immunohistochemical expression ≥ 1 percent for estrogen and / or progesterone receptor * Disease with radiological progression (at least 10 percent tumor volume growth) in the last 12 months before day 1 cycle 1. * No possibility of established treatments due to lack of access, risk of toxicities or without clinical indication. Patients who meet criteria for watchful waiting (low-dose disease and non-functioning NET) may be included. * Measurable disease * ECOG performance scale 0 to 2. * Adequate organic function as defined by the following criteria: * serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of local laboratory normality (LSN-LL); * Total serum bilirubin ≤ 2.0 x ULN-LL; * Absolute neutrophil count ≥ 1,500 / mm\^3; * Platelet count ≥ 80,000 / mm\^3; * Hemoglobin ≥ 9.0 g / dL; * Estimated creatinine clearance by the MDRD equation ≥ 30ml / min * Albumin ≥ 3.5 g / dL; * INR ≤ 1.5 * Term of free and informed consent signed by the patient or legal representative. Exclusion Criteria: * Patients already on tamoxifen, but other prior treatment are allowed * Patients with aggressive disease requiring cytotoxic therapy or locoregional therapies (eg hepatic embolization) * A history of serious clinical or psychiatric illness that, by clinical judgment, may involve participation risk in this study * Patients participating in other protocols with experimental drugs. * Patients with oral food difficulties. * Patients who underwent major recent surgery less than 4 weeks previously. * Patients receiving chemotherapy or other oncologic therapy for less than 3 weeks. * Patients who use oral anticoagulation * Previous history of deep vein thrombosis or pulmonary embolism in the last 12 months. * Pregnant or lactating patients. * Patients with postmenopausal vaginal bleeding with no defined etiology. * Patients with breast cancer who need to use tamoxifen for this neoplasm * Another synchronous neoplasm that requires systemic treatment
References
Publications (23)
- BACKGROUNDYao JC, Hassan M, Phan A, Dagohoy C, Leary C, Mares JE, Abdalla EK, Fleming JB, Vauthey JN, Rashid A, Evans DB. One hundred years after "carcinoid": epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol. 2008 Jun 20;26(18):3063-72. doi: 10.1200/JCO.2007.15.4377. PMID 18565894
- BACKGROUNDCaplin ME, Buscombe JR, Hilson AJ, Jones AL, Watkinson AF, Burroughs AK. Carcinoid tumour. Lancet. 1998 Sep 5;352(9130):799-805. doi: 10.1016/S0140-6736(98)02286-7. PMID 9737302
- BACKGROUNDModlin IM, Pavel M, Kidd M, Gustafsson BI. Review article: somatostatin analogues in the treatment of gastroenteropancreatic neuroendocrine (carcinoid) tumours. Aliment Pharmacol Ther. 2010 Jan 15;31(2):169-88. doi: 10.1111/j.1365-2036.2009.04174.x. Epub 2009 Oct 21. PMID 19845567
- BACKGROUNDCaplin ME, Pavel M, Ruszniewski P. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Oct 16;371(16):1556-7. doi: 10.1056/NEJMc1409757. No abstract available. PMID 25317881
- BACKGROUNDRinke A, Muller HH, Schade-Brittinger C, Klose KJ, Barth P, Wied M, Mayer C, Aminossadati B, Pape UF, Blaker M, Harder J, Arnold C, Gress T, Arnold R; PROMID Study Group. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol. 2009 Oct 1;27(28):4656-63. doi: 10.1200/JCO.2009.22.8510. Epub 2009 Aug 24. PMID 19704057
- BACKGROUNDViale G, Doglioni C, Gambacorta M, Zamboni G, Coggi G, Bordi C. Progesterone receptor immunoreactivity in pancreatic endocrine tumors. An immunocytochemical study of 156 neuroendocrine tumors of the pancreas, gastrointestinal and respiratory tracts, and skin. Cancer. 1992 Nov 1;70(9):2268-77. doi: 10.1002/1097-0142(19921101)70:93.0.co;2-x.