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

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

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

LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.

While no immunoassay is likely to be perfect in all clinical situations, results for the 5 hCG immunoassays evaluated suggest that all are adequate for use of hCG as a tumor marker in gestational trophoblastic disease and select germ cell tumors. Further harmonization of hCG methods is needed as serial testing for biochemical tumor monitoring must still be performed using a single method. Additional studies are needed to assess the utility of quantitative hCG as a tumor marker in other malignant disease.

P1, N=23, Completed, Luye Pharma Group Ltd. | Active, not recruiting --> Completed

P3, N=188, Completed, Luye Pharma Group Ltd. | Recruiting --> Completed

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

P3; N=188; Recruiting; Sponsor:Luye Pharma Group Ltd.

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.

P3, N=0, Withdrawn, AstraZeneca | N=168 --> 0 | Not yet recruiting --> Withdrawn

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=50, Recruiting, Washington University School of Medicine | Trial completion date: Jun 2025 --> Jan 2028 | Trial primary completion date: Jun 2021 --> Jun 2023

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.

N=160 --> 0 | Trial completion date: Nov 2024 --> Jan 2021 | Not yet recruiting --> Withdrawn | Trial primary completion date: Nov 2024 --> Jan 2021

EVE plus LET with ovarian-suppression resulted in longer PFS in tamoxifen-exposed HR+, HER2- metastatic breast cancer patients with visceral metastasis.

P2, N=40, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021

P3, N=608, Active, not recruiting, National Cancer Institute (NCI) | Trial primary completion date: Jan 2021 --> May 2020

This study showed the important roles of ERα in tumor progression and endocrine therapies of pancreatic cancer in women.

Poorly differentiated neuroendocrine carcinoma of the breast is rare and has a poor prognosis. Currently, there is no standard treatment for this disease. Studies show estrogen receptor and progesterone receptor of neuroendocrine carcinoma of the breast are often highly expressed. In the case, it can be observed that estrogen receptor and progesterone receptor are highly expressed. Therefore, neoadjuvant endocrine therapy may be considered in neuroendocrine carcinoma of the breast when the mass is large and the patient refuses neoadjuvant chemotherapy. We hope to provide an attractive evidence for neoadjuvant endocrine therapy of neuroendocrine carcinoma of the breast. However, more cases are still being needed for research.

Better clinical responses were observed in pre-menopausal patients after 24 weeks of NCT compared to those observed after NET.

At its current price, adding ribociclib to endocrine therapy is unlikely to be cost-effective in Singapore for HR+, HER2- ABC. Results from this study are useful to inform future funding decisions for CDK4/6 inhibitors alongside other factors including clinical effectiveness, safety, and budget impact considerations.

P2, N=26, Terminated, Washington University School of Medicine | N=48 --> 26 | Trial completion date: Dec 2021 --> Sep 2020 | Recruiting --> Terminated | Trial primary completion date: Oct 2021 --> Aug 2020; Futility

When a patient exhibits diarrhea while undergoing radiotherapy for PC, clinicians should be aware of the possibility of UC in addition to radiation colitis, and colonoscopy should be considered.

The addition of 2 years of OFS to TAM significantly improved DFS compared with TAM alone in patients who remained premenopausal or resumed ovarian function after chemotherapy.

CDK4/6i+F500 is likely the best treatment option in both endocrine-sensitive and endocrine-resistant diseases for PFS, and in endocrine-sensitive patients for OS. Concerning OS in endocrine-resistant patients, capivasertib+F500 and CDK4/6i+F500 are likely the best treatments.

Due to liver dysfunction, antiandrogens, both bicalutamide and flutamide, were stopped...Leuprorelin acetate was replaced by goserelin acetate...Androgen deprivation therapy is the standard treatment for patients with advanced prostate cancer and luteinizing hormone-releasing hormone aims to suppress serum testosterone to castrate range. We recommend assessing the serum testosterone levels during luteinizing hormone-releasing hormone agonist therapy for monitoring treatment efficacy and verifying progression when the PSA level increases.

To establish non-inferiority of gonadotropin-releasing hormone degarelix compared with goserelin in suppressing and maintaining castrate testosterone levels from Day 28 to Day 364 in Chinese patients with prostate cancer. PSA-PFS was significantly higher with degarelix, suggesting improved disease control. Both treatments were well tolerated.

The RP2Ds of alpelisib and buparlisib were 350 mg and 100 mg, respectively. No unexpected safety findings were reported. Although an early-phase study, data suggest that alpelisib plus endocrine therapy may be a potentially efficacious treatment that warrants further evaluation for premenopausal patients with HR+, HER2- ABC.

Funding: Novartis Pharmaceuticals Corporation. Clinical trial identification: NCT02941926.

Methods Pts in ML-3 (≤ 1 ET for ABC) were randomized 2:1 to RIB or PBO (both + fulvestrant)...Funding: Novartis Pharmaceutical Corporation. Clinical trial identification: NCT02422615 (September 19, 2018); NCT02278120 (February 26, 2019).

The 120-month progression-free survival confirmed the results from the primary analysis. Salvage radiotherapy combined with short-term androgen suppression significantly reduced risk of biochemical or clinical progression and death compared with salvage radiotherapy alone. The results of the GETUG-AFU 16 trial confirm the efficacy of androgen suppression plus radiotherapy as salvage treatment in patients with increasing PSA concentration after radical prostatectomy for prostate cancer.

Determination of molecular subtypes by IHC is an independent prognostic factor for recurrence and death in premenopausal women with early-stage, hormone receptor-positive breast cancer but is not predictive for outcome of adjuvant treatment with tamoxifen/goserelin or CMF.

P2, N=50, Recruiting, Washington University School of Medicine | Trial completion date: Jul 2024 --> Jun 2025 | Trial primary completion date: Jun 2020 --> Jun 2021