Eligard (leuprolide acetate)

P2, N=37, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended

P1, N=14, Recruiting, Roswell Park Cancer Institute | Not yet recruiting --> Recruiting

P2, N=180, Recruiting, Weill Medical College of Cornell University | Trial primary completion date: Feb 2025 --> Dec 2025

P2, N=33, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Jul 2024

P2, N=70, Not yet recruiting, Ohio State University Comprehensive Cancer Center

P1, N=14, Not yet recruiting, Roswell Park Cancer Institute

P3, N=280, Recruiting, University Medical Center Groningen | Trial completion date: Dec 2022 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2024

P1/2, N=93, Active, not recruiting, Praful Ravi, MB BCHir, MRCP | Recruiting --> Active, not recruiting

P2/3; N=493; Recruiting; Sponsor:Cancer Research Antwerp

P2, N=29, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Dec 2024

P2, N=37, Recruiting, National Cancer Institute (NCI) | Initiation date: Oct 2024 --> Feb 2024

P2, N=28, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Jan 2025

P=N/A, N=960, Completed, Bayer | Active, not recruiting --> Completed

P2, N=37, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting

P=N/A, N=300, Active, not recruiting, Chinese University of Hong Kong | Recruiting --> Active, not recruiting | N=600 --> 300

P2, N=70, Recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Aug 2027 | Trial primary completion date: Dec 2023 --> Aug 2027

P2, N=118, Active, not recruiting, Dana-Farber Cancer Institute

P3, N=250, Enrolling by invitation, Tolmar Inc.

P2, N=37, Not yet recruiting, National Cancer Institute (NCI)

P2, N=20, Recruiting, National Cancer Institute (NCI) | Initiation date: Jan 2024 --> Jul 2023

P2, N=25, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Apr 2025 | Trial primary completion date: Dec 2023 --> Apr 2025

P2, N=50, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting

P2, N=20, Recruiting, National Cancer Institute (NCI) | Initiation date: Oct 2023 --> Jan 2024

P2, N=20, Recruiting, National Cancer Institute (NCI) | Initiation date: Jul 2023 --> Oct 2023

P2, N=20, Recruiting, National Cancer Institute (NCI) | Initiation date: Apr 2023 --> Jul 2023

In pts with high-risk BCR, enza + ADT and enza mono demonstrated a statistically significant and clinically meaningful improvement in MFS vs pbo + ADT. The safety profile of enza was consistent with results from previous clinical studies.

P3; Recruiting --> Active, not recruiting | N=810 --> 27

P2, N=33, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023

P3, N=250, Recruiting, Tolmar Inc. | Trial completion date: Jun 2024 --> Apr 2025 | Trial primary completion date: Jun 2024 --> Apr 2025

Eligible subjects will enter the 48 week Treatment Period in 2 groups: those receiving tamoxifen concurrently with TOL2506 or those who initiate therapy with an aromatase inhibitor (AI; letrozole, anastrozole, or exemestane) beginning 6 weeks after the first administration of TOL2506, if E2 < 20 pg/mL has been achieved. Secondary endpoints include suppression of LH, E2 (< 20 pg/mL for tamoxifen cohort and < 2.72 pg/mL for AI cohort) and absence of menses at weeks 6, 12, 24, 36, and 48. NCT04906395

P2, N=70, Recruiting, City of Hope Medical Center | Active, not recruiting --> Recruiting | N=20 --> 70

P2, N=20, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting | N=70 --> 20

Eligible subjects will enter the 48 week treatment period in 2 groups: those receiving tamoxifen concurrently with TOL2506 or those who initiate therapy with an aromatase inhibitor (AI; letrozole, anastrozole, or exemestane) beginning 6 weeks after the first administration of TOL2506, if E2 < 20 pg/mL has been achieved. Achievement of ovarian suppression will be defined as ≥ 90% of subjects with luteinizing hormone (LH) levels < 4 IU/L at Week 6. Secondary endpoints include suppression of LH, E2 (< 20 pg/mL for tamoxifen cohort and < 2.72 pg/mL for AI cohort) and absence of menses at weeks 6, 12, 24, 36, and 48.

P3, N=250, Recruiting, Tolmar Inc. | Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Jun 2024

P2, N=70, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023

P3, N=250, Recruiting, Tolmar Inc. | Not yet recruiting --> Recruiting | Trial completion date: Sep 2023 --> Dec 2023 | Trial primary completion date: Sep 2023 --> Dec 2023

P3, N=250, Not yet recruiting, Tolmar Inc.

The phase 2 LEO study showed that everolimus (EVE) plus letrozole (LET) with ovarian suppression increased progression-free survival (PFS) in tamoxifen-exposed premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer with visceral metastases...Patients who were exposed to or progressed on tamoxifen as adjuvant/palliative treatments were randomly assigned (2:1) to the EVE (leuprorelin+LET+EVE, n=92) or LET (leuprorelin+LET, n=45) arm...EVE+LET with ovarian suppression prolonged PFS in patients with baseline visceral or bone metastases and offered bone-protective effects in the overall study population. However, these clinical benefits did not translate into an OS benefit.

Background: In phase II LEO study, everolimus (EVE) plus letrozole (LET) with ovarian suppression resulted in longer progression-free survival (PFS) in tamoxifen-exposed premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer with visceral metastases... EVE plus LET with ovarian-suppression prolonged PFS in patients with baseline visceral or bone metastases and offered bone-protective effect in the overall study population. However, these clinical benefits were not translated into an OS benefit.

P2, N=40, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022

P2, N=70, Not yet recruiting, City of Hope Medical Center

As PET-CT revealed recurrence of multiple bone and lung metastases and solitary liver metastasis which did not seem to be life-threatening, palliative radiation therapy and endocrine therapy with leuprorelin and anastrozole(LA)were started. LA therapy could be maintained for a total of 30 months until metastatic recurrence on liver and bone emerged. LA endocrine therapy may be effective for patients with premenopausal hormone-positive breast cancer even if the difficult situation such as tamoxifen intolerance.