NCT04008563: B-FiERCE

Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium

Recruiting now NA Last updated 14 March 2025

What this trial tests

NA trial testing Bariatric Surgery in Endometrial Cancer in 36 participants. Currently enrolling.

Timeline

14 May 2021

Primary endpoint
31 October 2025

31 March 2027

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	14 May 2021
Primary completion	31 October 2025
Estimated completion	31 March 2027
Sites	1 location across Canada

Drugs / interventions tested

• Bariatric Surgery

Conditions studied

• Endometrial Cancer — all drugs for Endometrial Cancer →
• Atypical Hyperplasia — all drugs for Atypical Hyperplasia →
• Bariatric Surgery Candidate — all drugs for Bariatric Surgery Candidate →

Sponsor

University Health Network, Toronto

Who can join

Adults 18 to 41, female only, with Endometrial Cancer or Atypical Hyperplasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A growing population of young women with obesity are developing atypical hyperplasia (pre-cancer) and endometrial cancer. Progestin is the standard treatment for women who wish to preserve fertility, but this approach does not address the underlying cause of endometrial cancer/atypical hyperplasia (obesity); thus response rates are low and recurrence rates are high. Significant weight loss by bariatric surgery, in combination with progestin therapy may result in greater and more durable response rates.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fertility-sparing treatment in early endometrial cancer: current state and future strategies.
   Obermair A, Baxter E, Brennan DJ, McAlpine JN, et al · · 2020 · cited 62× · PMID 32689770 · DOI 10.5468/ogs.19169
2. Endometrial Cancer in Reproductive Age: Fertility-Sparing Approach and Reproductive Outcomes.
   Mutlu L, Manavella DD, Gullo G, McNamara B, et al · · 2022 · cited 61× · PMID 36358604 · DOI 10.3390/cancers14215187
3. Fertility-Sparing Approaches in Atypical Endometrial Hyperplasia and Endometrial Cancer Patients: Current Evidence and Future Directions.
   Contreras NA, Sabadell J, Verdaguer P, Julià C, et al · · 2022 · cited 60× · PMID 35269674 · DOI 10.3390/ijms23052531
4. The Perspectives of Fertility Preservation in Women with Endometrial Cancer.
   Knez J, Al Mahdawi L, Takač I, Sobočan M. · · 2021 · cited 22× · PMID 33546293 · DOI 10.3390/cancers13040602
5. The role of obesity and bariatric surgery-induced weight loss in breast cancer.
   Bohm MS, Sipe LM, Pye ME, Davis MJ, et al · · 2022 · cited 19× · PMID 35870055 · DOI 10.1007/s10555-022-10050-6
6. Progestin Resistance and Corresponding Management of Abnormal Endometrial Hyperplasia and Endometrial Carcinoma.
   Lv M, Chen P, Bai M, Huang Y, et al · · 2022 · cited 17× · PMID 36551694 · DOI 10.3390/cancers14246210
7. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer.
   Agnew H, Kitson S, Crosbie EJ. · · 2023 · cited 16× · PMID 36971688 · DOI 10.1002/14651858.cd012513.pub3
8. Molecular Prognosticators Guiding Fertility-Sparing Surgery in Early-Stage Endometrial Cancer: A Comprehensive Review.
   Shaikh S, Haque S, Khalifey HT, Samour HA, et al · · 2025 · PMID 41300969 · DOI 10.3390/cancers17223602