FUlvestrant in Gynecological Cancers That Are Potentially Hormone Sensitive: the FUCHSia Study (FUCHSia)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    200
  • sponsor
    Frederic Amant
Updated on 3 February 2022
cancer
estrogen
measurable disease
carcinoma
progestin
endocrine therapy
metastasis
hormone therapy
liver metastasis
tamoxifen
ovarian cancer
sarcoma
endometrial carcinoma

Summary

In this phase 2 clinical trial, the aim is to evaluate the efficacy of the ER-antagonist Fulvestrant in women with estrogen receptor positive (ER+) low grade gynecological cancers. The primary objective of the study is to determine the response rate (RR) upon Fulvestrant treatment, comprising either partial or complete response, as determined by RECIST v1.1 criteria for each tumor type. The secondary objectives are to: (1) determine progression-free survival (PFS) upon Fulvestrant treatment, after 3 years, in each tumor type group (2) assess clinical benefit (CB) upon Fulvestrant treatment, comprising complete response, partial response and stable disease, as determined by RECIST v1.1 criteria, in each tumor type group (3) assess duration of response in each tumor type group (4) assess safety and tolerability of Fulvestrant administration in each tumor type group (5) assess quality of life (QoL) and symptoms in each tumor type group. As exploratory objectives, the aim is to: (1) evaluate the feasibility of 16-18F-fluoro-17-estradiol (18F-FES) PET imaging for detection of ER expression (2) determine the value of sequential 18F-FES PET scans in predicting response to Fulvestrant (3) collect tumor biopsies and cf-DNA from patients enrolled in the trial. These samples will be subsequently characterized at the genetic level, to identify adaptive response mechanisms to Fulvestrant treatment.

Details
Condition Endometrial Stromal Sarcoma, Adenosarcoma of Uterus, Leiomyosarcoma Uterus, Endometrial Cancer, Sex Cord Stromal Tumor, Serous Ovarian Tumor
Treatment fulvestrant
Clinical Study IdentifierNCT03926936
SponsorFrederic Amant
Last Modified on3 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent prior admission to the study
Age 18 years at the moment of signing the informed consent
Recurrent or metastatic low grade uterine sarcomas (low grade endometrial stromal sarcoma, low grade adenosarcoma without sarcomatous overgrowth and low grade leiomyosarcoma), low-grade endometrial carcinomas, sex cord stromal tumors (granulosa cell tumors...) and low grade serous ovarian cancer
Measurable disease, according to RECIST v1.1 criteria, assessed by CT scans
ER-positive tumors based on immunohistochemistry, assessed using the Allred scoring system (based on intensity and percentage of positive cells, see Appendix 4), and archival tissue available
At least and maximum of 1 prior line of hormonal therapy (tamoxifen, progestins and/or aromatase inhibitors). Response on 1st line hormonal therapy must have lasted for at least 3 months
Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
Demonstrate adequate organ function: platelets > 100 x 10E9/L, serum total bilirubin < 1.5x Upper Limit of Normal (ULN) (patients with confirmed Gilbert's syndrome may be included in the study), alanine transaminase or aspartate transaminase < 2.5x ULN if no demonstrable liver metastases or < 5x ULN in presence of liver metastases
Post-menopausal status as defined by (i) age 60 or more, or (ii) age 45-59 and satisfying the following criteria: amenorrhea for at least 12 months and FSH in postmenopausal range, or (iii) 18 years of age and having had a bilateral oophorectomy
Be willing to receive 18F-FES PET scan. Exceptions will be made in case of (i) patients living far from one of the imaging centers and for whom travelling would be a too high burden for their physical conditions; (ii) patients who received tamoxifen within 8 weeks prior to study Day 1. These patients will be enrolled, but they will not receive a FES PET scan
Be willing to donate a core tumor biopsy if technically feasible

Exclusion Criteria

Any other active malignancy or primary malignancy diagnosed within the previous 5 years, except for adequately treated squamous or basal cell carcinoma of the skin or in situ cervical carcinoma
Patients currently receiving (and unwilling to discontinue) any estrogen replacement therapy
Patients participating in a study or having participated in a study of an investigational agent and received study therapy (or used an investigational device) within 4 weeks prior to study Day 1
Patients who received prior chemo- or targeted therapy within 4 weeks prior to study Day 1 or who has not recovered from adverse events (i.e., adverse event not resolved to Grade 1 or baseline), due to a previously administered agent
Patients with no archival tissue available, except for patients from whom an additional fresh core biopsy can be obtained for ER assessment
Any other disease, metabolic dysfunction, physical examination or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interfere with obtaining informed consent
Any condition not permitting compliance with the study protocol
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