Faslodex 250 mg solution for injection.
Sponsors
Grupo Espanol De Investigacion En Cancer De Mama, F. Hoffmann-La Roche AG, Carrick Therapeutics Limited, AstraZeneca AB, Astrazeneca AB
Conditions
Advanced Breast Cancer in older patientsBreast cancer patients including those with locally advanced (unresectable) or metastatic HER2-positiveER-positive and HER2-negative metastatic or locally advanced breast cancer with either a germline or somatic BRCA mutationEstrogen Receptor (ER)-PositiveEstrogen receptor (ER)-positiveHER2-NegativeHER2-negative advanced breast cancerHR+/HER2-Negative Locally Advanced or Metastatic Breast cancer with PIK3CA
mutation
Phase 1
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients with Metastatic Breast Cancer (MORPHEUS-panBC)
RecruitingCTIS2023-503629-20-00
Start: 2018-06-27Target: 50Updated: 2025-08-14
A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination with Other Anti-cancer Agents in Patients with Metastatic HER2-low Breast Cancer (DESTINY-Breast08)
Active, not recruitingCTIS2023-505690-33-00
Start: 2022-03-11Target: 12Updated: 2026-01-21
Phase 2
CT7001_002 (SUMIT-BC) - An open-label Interventional, Multicenter, Randomized, Phase 2 Study of Fulvestrant with or without Samuraciclib in Participants with Metastatic or Locally Advanced Hormone Receptor Positive and Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
CompletedCTIS2023-503903-27-00
Start: 2023-10-11End: 2025-09-02Target: 24Updated: 2025-07-17
C4251003- A Phase 2 Basket Study of Tucatinib in Combination with Trastuzumab in Subjects with Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations.
Active, not recruitingCTIS2024-511481-37-00
Start: 2021-07-12Target: 29Updated: 2025-06-17
Phase II neoadjuvant study evaluating capivasertib plus fulvestrant vs fulvestrant in patients with primary high-risk lobular breast cancer- LOBSTER
RecruitingCTIS2023-509292-17-00
Start: 2024-11-08Target: 120Updated: 2026-01-09
Phase 2a Study of ZW25 in Combination with Palbociclib Plus Fulvestrant
CompletedCTIS2023-508135-30-00
Start: 2019-12-09End: 2025-06-30Target: 86Updated: 2025-03-25
DOLAF : An international multicenter phase II trial of Durvalumab (MEDI4736) plus OLAparib plus Fulvestrant in metastatic or locally advanced ER-positive, HER2-negative breast cancer patients selected using criteria that predict sensitivity to olaparib
Active, not recruitingCTIS2024-516847-23-00
Start: 2019-08-27Target: 172Updated: 2026-01-12
A randomized, double-blind, parallel-group, multicentre, phase II study to compare the efficacy and tolerability of fulvestrant (FaslodexTM) 500mg with placebo and fulvestrant (FaslodexTM) 500mg in combination with PD-0332991 (Palbociclib) as first line treatment for postmenopausal women with hormone receptor-positive metastatic breast cancer, who have completed at least 5 years of adjuvant endocrine therapy and remained disease free for more than 12 months following its completion or have de novo metastatic disease. "The FLIPPER Study"
RecruitingCTIS2024-516132-10-00
Start: 2016-02-05Target: 189Updated: 2025-09-26
Phase 3
A Phase Ib/III, Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)
RecruitingCTIS2023-504997-39-00
Start: 2021-06-14Target: 214Updated: 2026-01-26
IMPlementing geriatric assessment for dose Optimization of CDK 4/6-inhibitors in older bReasT cAncer patieNTs – a pragmatic randomized-controlled trial (IMPORTANT trial)
RecruitingCTIS2023-506620-87-00
Start: 2024-01-25Target: 495Updated: 2025-07-10
A Phase III, Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared with Fulvestrant, both Combined with a CDK4/6 Inhibitor, in Patients with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer with Resistance to Prior Adjuvant Endocrine Therapy
RecruitingCTIS2022-502980-39-00
Start: 2024-01-25Target: 296Updated: 2026-01-13
A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2−) Breast Cancer Following Recurrence or Progression On or After Treatment with an Aromatase Inhibitor (CAPItello-291)
Active, not recruitingCTIS2023-505042-25-00
Start: 2020-05-05Target: 366Updated: 2025-11-25
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared with the Physician’s Choice of Endocrine Therapy Plus Everolimus in Patients with Estrogen Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer
Active, not recruitingCTIS2023-506821-12-00
Start: 2023-10-12Target: 59Updated: 2025-12-17
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients with PIK3CA -Mutant, Hormone Receptor-Positive, HER2 -Negative Locally Advanced or Metastatic Breast Cancer
Active, not recruitingCTIS2023-505812-39-00
Start: 2020-08-28Target: 91Updated: 2025-11-12
C4391022 - AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR’S CHOICE OF THERAPY IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY
CompletedCTIS2023-506487-13-00
End: 2025-02-13Target: 174Updated: 2024-12-17