Abstract 3534
Background
Patients (pts) with advanced neuroendocrine tumors (NET) represent an unmet medical need, what motivates the development of new treatments. Prior retrospective study conducted by our group showed that among 96 NET, immunohistochemistry (IHC) expression for estrogen (ER) and progesterone receptors (PR) were observed in 20.8% and 18.8% of cases, respectively. Additionally, an old clinical trial (Mortel C, 1984) suggested antitumor effects of estrogen/progesterone-directed therapies in NET pts. Yet the effects of an antiestrogen agent in NET pts whose tumor express ER and/or PR are unknown. Hence we will conduct a clinical trial to test the efficacy of tamoxifen in ER/PR positive NET pts.
Trial design
Single-arm phase II multicenter trial of tamoxifen 20mg PO continuously until intolerance and/or tumor progression. Eligible pts must be ≥ 18 years old, have histologically confirmed advanced, irresectable well-differentiated lung or gastroeteropancreatic NET, IHC expression of ER and/or PR ≥ 1%, documented progression in the prior 12 months, measurable disease, prior treatments with standard therapies and/or no indication to start new treatment due to lack of access, risk of toxicities or without clinical indication (patients who meet criteria for watchful waiting may be included), ECOG 0-2, adequate organ function. Main exclusion criteria are: aggressive disease requiring cytotoxic therapy, use of oral anticoagulants, previous history of deep vein thrombosis or pulmonary embolism in the last 12 months, postmenopausal vaginal bleeding with no defined etiology. The primary endpoint is disease control rate (DCR) at week 24 as per RECIST 1.1. Secondary endpoints are progression-free survival, biochemical response, response rate. Exploratory evaluations: circulating tumor cells kinetics (qualitative and quantitative) and PET-CT gallium-68 intake intensity variation (at baseline and at week 24). Sample size assumptions: the H0 is DCR at week 24 of 50% and H1, 70%; with a type I error of 10%, power of 80% and attrition rate of 30%, the final sample size will be 22 pts.
Clinical trial identification
NCT03870399.
Editorial acknowledgement
Legal entity responsible for the study
Rachel Riechelmann.
Funding
AC Camargo Cancer Center.
Disclosure
M. Barros: Honoraria (self): Novartis. J.F. Rego: Honoraria (self): Novartis. R.P. Riechelmann: Honoraria (self): Novartis. All other authors have declared no conflicts of interest.
Resources from the same session
3695 - A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation
Presenter: Heinz Josef Lenz
Session: Poster Display session 2
Resources:
Abstract
4250 - Phase II study of avelumab in combination with cetuximab as a rechallenge strategy in pre-treated RAS wild type metastatic colorectal cancer patients: CAVE (cetuximab-avelumab) Colon.
Presenter: Erika Martinelli
Session: Poster Display session 2
Resources:
Abstract
5234 - The ORCHESTRA trial; A phase III trial of adding tumor debulking to systemic therapy versus systemic therapy alone in multi-organ metastatic colorectal cancer (mCRC).
Presenter: Lotte Bakkerus
Session: Poster Display session 2
Resources:
Abstract
5294 - EMERGE: Epigenetic Modulation of the Immune Response in Gastrointestinal cancers
Presenter: Elizabeth Cartwright
Session: Poster Display session 2
Resources:
Abstract
913 - Phase III, international, multicenter, randomized, open-label trial of adjuvant nab-paclitaxel plus gemcitabine (nab-P/G) vs gemcitabine (G) alone for surgically resected pancreatic adenocarcinoma (APACT): subgroup analyses
Presenter: Margaret Tempero
Session: Poster Display session 2
Resources:
Abstract
1668 - FOLFIRINOX in locally advanced (LA) and borderline resectable (BR) pancreatic adenocarcinoma : update of the AGEO cohort.
Presenter: Edouard Auclin
Session: Poster Display session 2
Resources:
Abstract
2559 - Impact of adjuvant treatment with nab-paclitaxel and gemcitabine (nab-P+GEM) vs gemcitabine alone (GEM) on health-related quality of life (QoL) in patients (pts) with surgically resected pancreatic adenocarcinoma (PA) in the Adjuvant Pancreatic Adenocarcinoma Clinical Trial (APACT)
Presenter: Hanno Riess
Session: Poster Display session 2
Resources:
Abstract
4897 - Early detection of pancreatic ductal adenocarcinoma using methylation signatures in circulating tumor DNA
Presenter: Xiao-ding Liu
Session: Poster Display session 2
Resources:
Abstract
1755 - Evaluation of minimal important difference (MID) for the European Organisation for Research and Treatment of Cancer (EORTC) Pancreatic Cancer Module (PAN26) in patients with surgically resected pancreatic adenocarcinoma
Presenter: Michele Reni
Session: Poster Display session 2
Resources:
Abstract
2876 - Multispectral analysis of lymphocyte complexity in periampullary adenocarcinoma
Presenter: Sebastian Lundgren
Session: Poster Display session 2
Resources:
Abstract