Skip to content

Letrozol STADA® 2

DRUG5 trials

Sponsors

F. Hoffmann-La Roche AG, Verastem Inc., Celcuity Inc.

Conditions

Endocrine-Sensitive phosphatidylinositol 3-kinase (PIK3CA)-MutatedEstrogen Receptor-PositiveHER2-Negative Early Breast CancerHER2-negativeHR-positiveHormone Receptor-PositiveMetastatic breast cancerRecurrent Low-Grade Serous Ovarian Cancer (LGSOC)

Phase 1

Phase 3

A Phase 3, Randomized, Open-Label Study of Combination Therapy with Avutometinib plus Defactinib Versus Investigator’s Choice of Treatment in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP301)
RecruitingCTIS2023-508204-38-00
Verastem Inc.Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Start: 2024-07-02Target: 183Updated: 2026-01-06
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared with Physician’s Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, Her2-Negative Early Breast Cancer
Active, not recruitingCTIS2023-507172-44-00
F. Hoffmann-La Roche AGEstrogen Receptor-Positive, HER2-Negative Early Breast Cancer
Start: 2021-09-10Target: 1482Updated: 2025-11-25
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients with Endocrine-Sensitive PIK3CA -Mutated, Hormone Receptor-Positive, HER2- Negative Advanced Breast Cancer
RecruitingCTIS2024-516162-11-00
F. Hoffmann-La Roche AGEndocrine-Sensitive phosphatidylinositol 3-kinase (PIK3CA)-Mutated, Hormone Receptor-Positive, human epidermal growth factor receptor 2- (HER2-) negative advanced breast cancer
Start: 2025-07-14Target: 176Updated: 2025-11-10
VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib with Endocrine Therapy and Palbociclib vs Endocrine Therapy and Ribociclib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer
Not yet recruitingCTIS2024-518933-28-01
Celcuity Inc.advanced breast cancer (ABC) without any prior systemic anticancer therapy for ABC, advanced breast cancer (ABC) without any prior systemic anticancer therapy for ABC Study 2: Endocrine-sensitive, HER2-negative +2
Target: 229Updated: 2026-10-28