Study of Tamoxifen in Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression (HORMONET)
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|ClinicalTrials.gov Identifier: NCT03870399|
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors Progesterone Receptor Positive Tumor Estrogen Receptor Positive Tumor||Drug: Tamoxifen||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A single-arm, unicentric, single-stage clinical study|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Hormone Therapy With Tamoxifen in Patients With Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression|
|Actual Study Start Date :||March 13, 2019|
|Estimated Primary Completion Date :||March 13, 2022|
|Estimated Study Completion Date :||March 13, 2025|
The participants will receive tamoxifen 20mg orally once daily with a glass of water. Each cycle will be defined for 42 days (6 weeks).
The treatment to be used will be tamoxifen 20mg orally once daily.
- Disease control rate [ Time Frame: at 24 weeks after initiation of tamoxifen (at the end of cycle 6 - each cycle is 28 days) ]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.
- Progression-free survival [ Time Frame: Through study completion, an average of 5 years ]Defined by time from tamoxifen day 1 cycle 1 to death from any cause or radiological progression by RECIST 1.1, whichever occurs first. Patients alive and without progression at the time of study analysis will be censored for time-to-event analysis.
- Rate of Biochemical response [ Time Frame: Through study completion, an average of 5 years ]Defined by at least 30 percent drop in the marker (chromogranin and / or specific hormone) at any time of treatment in relation to pre-treatment value
- Radiological response rate [ Time Frame: Through study completion, an average of 5 years ]Assessed by RECIST criteria 1.1
- Disease control rate [ Time Frame: Through study completion, an average of 5 years ]defined by absence of radiological progression by RECIST 1.1 criteria, according to the intensity of expression by immunohistochemistry (IHC) of HR and also according to primary site (pancreas, gastrointestinal or lung)
- Incidence of Treatment-related Adverse Events [ Time Frame: Through study completion, an average of 5 years ]Frequency of adverse events of grades 2 or more by Common Adverse Event Toxicity Criteria (CTCAE) version 5.0
- PET-CT gallium-68 intake variation [ Time Frame: Through study completion, an average of 3 years ]Evaluate possible variations in intensity of intake between PET-CT gallium-68 pre-treatment and 12 weeks after initiation of tamoxifen as a continuous variable for each capture lesion.
- PET-CT gallium-68 number variation [ Time Frame: Through study completion, an average of 3 years ]Evaluate possible variations in number of sites with intake between PET-CT gallium-68 pre-treatment and 12 weeks after initiation of tamoxifen as a continuous variable for each capture lesion.
- CTC positivity rate [ Time Frame: Through study completion, an average of 3 years ]Evaluate the percentage of CTC positivity in NET.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870399
|Contact: Rachel SP Riechelmann, Phd||+55 11 2180-5000 ext firstname.lastname@example.org|
|Contact: Mauro DS Donadio, Dr||+55 11 2180-5000 ext email@example.com|
|Principal Investigator:||Rachel SP Riechelmann, Phd||Fundacao Antonio Prudente|