Soltamox (tamoxifen citrate) / Jazz - LARVOL DELTA

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer (clinicaltrials.gov) - P3 | N=5083 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | N=10000 ➔ 5083 | Trial completion date: Feb 2023 ➔ Mar 2024

Enrollment change • 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

Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer (clinicaltrials.gov) - P2 | N=8 | Completed | Sponsor: Irada Ibrahim-zada | Active, not recruiting ➔ Completed

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

TALES: Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial (clinicaltrials.gov) - P3 | N=309 | Recruiting | Sponsor: University of California, San Francisco | Trial completion date: Mar 2026 ➔ Mar 2028 | Trial primary completion date: Mar 2026 ➔ Mar 2028

Trial completion date • Trial primary completion date • Breast Cancer • Infertility • Oncology • Sexual Disorders

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 | Trial completion date: May 2027 ➔ May 2029 | Trial primary completion date: Nov 2026 ➔ Nov 2028

Trial completion date • Trial primary completion date • Oncology • Pancreatic Cancer

PIKALO-1: First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=880 | Recruiting | Sponsor: Eli Lilly and Company | N=178 ➔ 880

Enrollment change • First-in-human • Monotherapy • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PIK3CA

ETHAN - ET for Male BC (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Jose Pablo Leone | Trial primary completion date: Apr 2026 ➔ Apr 2027

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

A011203: 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 2026 ➔ Feb 2027

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

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: Oct 2032 ➔ Jan 2027

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

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer (clinicaltrials.gov) - P3 | N=10000 | Recruiting | Sponsor: National Cancer Institute (NCI) | N=5000 ➔ 10000

Clinical • 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, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer (clinicaltrials.gov) - P3 | N=5000 | Recruiting | Sponsor: National Cancer Institute (NCI) | N=4000 ➔ 5000

Clinical • 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, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer (clinicaltrials.gov) - P3 | N=10000 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • ER • HER-2 • PGR

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer (clinicaltrials.gov) - P3 | N=10000 | Recruiting | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Recruiting

Enrollment open • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • ER • HER-2 • PGR

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer (clinicaltrials.gov) - P3 | N=10000 | Recruiting | Sponsor: National Cancer Institute (NCI)

New P3 trial • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • ER • HER-2 • PGR

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

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer (clinicaltrials.gov) - P3 | N=10000 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Feb 2022 ➔ Feb 2023 | Trial primary completion date: Feb 2022 ➔ Feb 2023

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 • 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 | Recruiting | Sponsor: University of Chicago | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer (clinicaltrials.gov) - P1 | N=4 | Terminated | Sponsor: Jennifer Lee Caswell-Jin | Phase classification: P1b ➔ P1

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

Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer (clinicaltrials.gov) - P2 | N=19 | Completed | Sponsor: Jennifer Lee Caswell-Jin | Suspended ➔ Completed

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

Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer (clinicaltrials.gov) - P2 | N=8 | Active, not recruiting | Sponsor: Irada Ibrahim-zada | Recruiting ➔ Active, not recruiting | N=70 ➔ 8 | Trial completion date: Oct 2036 ➔ Jun 2026 | Trial primary completion date: Oct 2026 ➔ Dec 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

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

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

Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer (clinicaltrials.gov) - P2 | N=19 | Suspended | Sponsor: Stanford University | Active, not recruiting ➔ Suspended

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

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