Overview

Study of Tamoxifen in Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression

Status:
Recruiting
Trial end date:
2025-03-13
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AC Camargo Cancer Center
Treatments:
Hormones
Tamoxifen
Criteria
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