HORMONET: Phase II Study of Hormone Therapy With Tamoxifen in Patients With Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression

STATUS

Recruiting
End date

Jun 28, 2023
participants needed

15
sponsor

H. Lee Moffitt Cancer Center and Research Institute

Send

Updated on 28 October 2022

See if I qualify

platelet count

measurable disease

neutrophil count

who 2017

pancreatic net

Summary

This is a single-arm, single-stage clinical study of tamoxifen for patients with well-differentiated neuroendocrine tumors and radiological progression with positive (> 1%) HR (estrogen and/or progesterone) expression by immunohistochemistry (IHC).

Details

Condition	Neuroendocrine Tumors, Progesterone Receptor Positive Tumor, Estrogen Receptor Positive Tumor
Treatment	Tamoxifen 20 mg
Clinical Study Identifier	NCT04123262
Sponsor	H. Lee Moffitt Cancer Center and Research Institute
Last Modified on	28 October 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 (ULN-LL); (up to 5xULN for participants with liver metastases)
	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
	Participants already on tamoxifen, but other prior treatment are allowed
	Participants 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
	Participants participating in other protocols with experimental drugs
	Participants with oral food difficulties
	Participants who underwent major recent surgery less than 4 weeks previously
	Participants receiving chemotherapy or other oncologic therapy for less than 3 weeks
	Participants who use oral anticoagulation
	Previous history of deep vein thrombosis or pulmonary embolism in the last 12 months
	Pregnant or lactating participants
	Participants with postmenopausal vaginal bleeding with no defined etiology
	Participants with breast cancer who need to use tamoxifen for this neoplasm
	Another synchronous neoplasm that requires systemic treatment

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

HORMONET: Phase II Study of Hormone Therapy With Tamoxifen in Patients With Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression