Soltamox (tamoxifen citrate) / Jazz - LARVOL DELTA

TALES: Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial (clinicaltrials.gov) - P3 | N=309 | Recruiting | Sponsor: University of California, San Francisco | N=144 ➔ 309 | Trial completion date: Jan 2025 ➔ Mar 2026 | Trial primary completion date: Jan 2025 ➔ Mar 2026

Enrollment change • Trial completion date • Trial primary completion date • Infertility • Sexual Disorders

PRO30178: Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Node-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=37 | Completed | Sponsor: Medical College of Wisconsin | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PGR

SOFT: Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (clinicaltrials.gov) - P3 | N=3066 | Completed | Sponsor: ETOP IBCSG Partners Foundation | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Nov 2024 | Trial primary completion date: May 2014 ➔ Nov 2024

Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • PGR

Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=81 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Feb 2025 ➔ Feb 2026

Trial completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • NCOA3

Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery (clinicaltrials.gov) - P2 | N=74 | Not yet recruiting | Sponsor: University of Chicago | Initiation date: Jan 2025 ➔ Jan 2026

Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

EMPRESS: Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10% (clinicaltrials.gov) - P2 | N=92 | Completed | Sponsor: MedSIR | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

MCN_Tam: Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: University of Nebraska | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Oncology • Pancreatic Cancer

EMPRESS: Preoperative Window Opportunity Study with Giredestrant or Tamoxifen in Premenopausal Women with ER+/HER2[-] & Ki67≥10% (clinicaltrials.gov) - P2 | N=92 | Active, not recruiting | Sponsor: MedSIR | Recruiting ➔ Active, not recruiting | Trial primary completion date: Nov 2024 ➔ Feb 2025

Enrollment closed • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer (clinicaltrials.gov) - P2/3 | N=260 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Oct 2024 ➔ Oct 2025

Trial completion date • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor • BRAF

Chemotherapy Before Surgery and Tissue Sample Collection in Patients With Stage IIA-IIIC Breast Cancer (clinicaltrials.gov) - P=N/A | N=31 | Terminated | Sponsor: Albert Einstein College of Medicine | N=132 ➔ 31 | Active, not recruiting ➔ Terminated; Interventional component of study terminated prior to full enrollment

Enrollment change • Trial termination • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

Tamoxifen Reduces Ipsilateral Breast Recurrence in Good-Risk Ductal CIS (OncLive) - P3 | N=636 | NCT00003857 | P2 | N=711 | NCT00002934 | "An ancillary analysis of the phase 3 NRG/RTOG 9804 (NCT00003857) and ECOG-ACRIN E5194 (NCT00002934) trials showed that tamoxifen (Soltamox) was associated with a reduced risk of 15-year ipsilateral breast recurrence (IBR) in patients with good-risk ductal carcinoma in situ (DCIS) treated without radiation therapy (RT)....Findings showed that treatment with tamoxifen elicited a statistically significant reduction in 15-year overall IBR by 11.4% (95% CI, 7.9%-15.5%) with tamoxifen vs 19.0% (95% CI, 15.3%-22.9%) without it (HR, 0.52; 95% CI, 0.35-0.77; P = .001). The 15-year risk of DCIS IBR was not significantly impacted by tamoxifen (5.5%) compared with those who did not receive it (8.1%; HR, 0.61; 95% CI, 0.34-1.08). For those with invasive IBR, there was a significant reduction with tamoxifen use (6.0%) compared with those who did not (11.5%; HR, 0.47; 95% CI, 0.27-0.80; P = .005)."

Breast Cancer

Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered Through Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast (clinicaltrials.gov) - P2 | N=100 | Completed | Sponsor: Northwestern University | Recruiting ➔ Completed | Phase classification: P2b ➔ P2

Phase classification • Trial completion • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER

Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery (clinicaltrials.gov) - P2 | N=74 | Not yet recruiting | Sponsor: University of Chicago | Initiation date: Jul 2024 ➔ Jan 2025

Surgery • Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

PRO30178: Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Node-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=37 | Active, not recruiting | Sponsor: Medical College of Wisconsin | Trial completion date: Jul 2024 ➔ Mar 2025

Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PGR

Umbrella Trial Testing Integrative Subtype Targeted Therapeutics in Estrogen Receptor Positive, HER2-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=19 | Active, not recruiting | Sponsor: Stanford University | Recruiting ➔ Active, not recruiting | N=150 ➔ 19

Enrollment change • Enrollment closed • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer (clinicaltrials.gov) - P3 | N=394 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jul 2024 ➔ May 2025

Metastases • Trial completion date • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • PGR

MCN_Tam: Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: University of Nebraska | Initiation date: May 2024 ➔ Sep 2024

Trial initiation date • Hepatology • Oncology • Pancreatic Cancer

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer (clinicaltrials.gov) - P3 | N=5018 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2024 ➔ Oct 2032

Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: Johns Hopkins University | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • PGR

Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery (clinicaltrials.gov) - P2 | N=74 | Not yet recruiting | Sponsor: University of Chicago

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

MCN_Tam: Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: University of Nebraska

New P1 trial • Hepatology • Oncology • Pancreatic Cancer

Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=81 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: May 2024 ➔ Feb 2025

Metastases • Trial completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • NCOA3

EMPRESS: Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10% (clinicaltrials.gov) - P2 | N=92 | Recruiting | Sponsor: MedSIR

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

ASPIRE: Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis (clinicaltrials.gov) - P2 | N=38 | Completed | Sponsor: Emory University | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer (clinicaltrials.gov) - P2/3 | N=260 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Oct 2023 ➔ Oct 2024

Trial completion date • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor • BRAF