Clinical trials: ER+ Breast Cancer
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1…
- Conditions
- HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors, HR+ HER2- Breast Cancer
- Trial name
- NCT07029399
- Testing
- NKT5097 CDK2/CDK4 dual degrader, Fulvestrant, Letrozole
- Where
- 19 sites in United States
- Volunteers
- 361 people
- Sponsor
- NiKang Therapeutics, Inc.
ER-Negative PR-Negative HER2-Negative Breast Cancer
Evaluation of Pharmacodynamic Effects of IT-pIL12-EP in Patients With TNBC
Intratumoral plasmid IL-12 electroporation (IT-pIL12-EP) will be administered to approximately 10 patients with triple negative breast cancer (TNBC) with cutaneous or subcutaneous disease.
- Trial name
- TNBC (NCT02531425)
- Testing
- IT-pIL12-EP
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- OncoSec Medical Incorporated
Advanced Breast Cancer, Metastatic Breast Cancer
A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg
This study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer.
- Trial name
- FINDER II (NCT00313170)
- Testing
- Fulvestrant
- Where
- 34 sites in Belgium, Canada and 6 more
- Volunteers
- 144 people
- Sponsor
- AstraZeneca
Breast Cancer
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
The purpose of this study is to determine the safety and efficacy of PF-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people with breast cancer: HR-positive…
- Trial name
- FourLight-3 (NCT06760637)
- Testing
- PF-07220060, letrozole, abemaciclib
- Where
- 460 sites in United States, Argentina and 28 more
- Volunteers
- 1,035 people
- Sponsor
- Pfizer
Breast Neoplasms
A Phase II Trial of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in Participants With Breast Cancer (MK-8669-064)
The purpose of the study is to evaluate the efficacy of the triplet of ridaforolimus, dalotuzumab and exemestane compared to the combination of ridaforolimus and exemestane in post-menopausal participants with breast cancer.
- Trial name
- NCT01605396
- Testing
- Ridaforolimus, Dalotuzumab, Exemestane
- Volunteers
- 80 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer
Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2…
- Trial name
- VIKTORIA-1 (NCT05501886)
- Testing
- Gedatolisib, Palbociclib, Fulvestrant
- Where
- 235 sites in United States, Argentina and 21 more
- Volunteers
- 701 people
- Sponsor
- Celcuity Inc
Breast Cancer
A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer
This study will evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GDC-9545 as a single agent and in combination with palbociclib and/or luteinizing hormone-releasing…
- Trial name
- NCT03332797
- Testing
- GDC-9545, Palbociclib, LHRH Agonist
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 181 people
- Sponsor
- Genentech, Inc.
Breast Cancer
Optimal Duration of Pre-operative Treatment With Letrozole and to Correlate Clinical Efficacy With Appropriate Surrogate Markers
This study will assess optimal duration of pre-operative treatment with letrozole and to correlate clinical efficacy with appropriate surrogate markers.
- Trial name
- NCT00535418
- Testing
- Letrozole
- Volunteers
- 35 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer
STAGE 1: To determine the safety of enobosarm 9 milligram (mg) once daily (QD) used in combination with a CDK 4/6 inhibitor [Verzenio® (abemaciclib) tablets, for oral use, 150 mg twice daily (BID)].
- Trial name
- VERU-024 (NCT05065411)
- Testing
- Enobosarm & Abemaciclib Combo, non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant
- Where
- 30 sites in United States
- Volunteers
- 5 people
- Sponsor
- Veru Inc.
Breast Neoplasms
Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant
The purpose of this study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women with estrogen receptor positive (ER+), human…
- Trial name
- NCT02374099
- Testing
- CC-486, Fulvestrant
- Where
- 35 sites in United States, Belgium and 4 more
- Volunteers
- 97 people
- Sponsor
- Celgene
Triple Negative Locally Advanced Non-resectable Breast Cancer, Metastatic Breast Cancer
Randomized Phase II Study of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative Locally Advanced Non-resectable and/or Metastatic Breast Cancer
The purpose of this study was to estimate the response rate of ixabepilone monotherapy, and the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with triple negative (estrogen receptor [ER]…
- Trial name
- NCT00633464
- Testing
- ixabepilone, ixabepilone + cetuximab
- Where
- 19 sites in Austria, Czechia and 5 more
- Volunteers
- 79 people
- Sponsor
- R-Pharm
Breast Cancer
Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer
Primary Objectives: Dose Escalation: To assess the incidence rate of dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) as well as the recommended dose (RD) of amcenestrant administered as monotherapy…
- Trial name
- AMEERA-1 (NCT03284957)
- Testing
- Amcenestrant, Palbociclib, Alpelisib
- Where
- 25 sites in United States, Belgium and 8 more
- Volunteers
- 136 people
- Sponsor
- Sanofi
Breast Cancer
Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer
This study is being carried out to see if treatment with ZD1839 (Gefitinib) combined with Arimidex (Anastrozole) has improved efficacy over Arimidex alone in preventing progression of metastatic breast cancer.
- Trial name
- NCT00077025
- Testing
- Gefitinib, Anastrozole
- Where
- 27 sites in United States, Colombia and 2 more
- Volunteers
- 174 people
- Sponsor
- AstraZeneca
Breast Cancer
CYP2D6 Genotypes and Breast Cancer Clinical Outcomes in the Indonesian Population
The utilization of tamoxifen is considerably high in Indonesia, with about 170,000 tamoxifen prescriptions filed in 2015. It is metabolized by the enzyme CYP2D6, resulting in its active metabolite, endoxifen, which has been…
- Trial name
- NCT05501158
- Testing
- Tamoxifen
- Where
- Indonesia
- Volunteers
- 150 people
- Sponsor
- Nalagenetics Pte Ltd
Advanced ER+/HER2- Breast Cancer
Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients
This study is a multi-center, open label, phase Ib/II clinical trial aimed at evaluating the safety, preliminary efficacy characteristic and PK characteristics of QLS1304 in combined with endocrine therapy in ER+/HER2- breast…
- Trial name
- NCT07235176
- Testing
- QLS1304 tablet+Fulvestrant or QLC1401, QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Breast Neoplasms, Breast Cancer
Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive…
- Conditions
- Breast Neoplasms, Breast Cancer, Estrogen-receptor Positive Breast Cancer, Cancer, Breast
- Trial name
- NCT03250676
- Testing
- H3B-6545
- Where
- 39 sites in United States, France and 1 more
- Volunteers
- 151 people
- Sponsor
- Eisai Inc.
Advanced Estrogen Receptor Positive HER2- Breast Cancer
GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer
The primary objectives of the Phase 1b Dose Escalation part of this study are to characterize the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant and to determine the maximum tolerated dose (MTD)…
- Trial name
- NCT02983604
- Testing
- GS-5829, Exemestane, Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 14 people
- Sponsor
- Gilead Sciences
Breast Cancer
A Rollover Protocol of Elacestrant, in Combination With Onapristone, for Patients With ER+, PR+, HER2- Advanced or Metastatic Breast Cancer
This is a rollover study for patients enrolled in the discontinued ELONA clinical trial (ONA-XR-103) with the primary objective to characterize the safety of elacestrant in combination with onapristone either alone or in…
- Trial name
- NCT06938711
- Testing
- Elacestrant, Onapristone
- Where
- United States
- Sponsor
- Context Therapeutics Inc.
Early Breast Cancer, Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-)
A Study of a Medicine Called Atirmociclib in Combination With Giredestrant in Adult Participants With ER-positive, HER2-negative Early-stage Breast Cancer
This Phase 3 study will evaluate whether atirmociclib plus giredestrant improves invasive breast cancer-free survival compared with giredestrant alone in adults with ER-positive, HER2-negative early breast cancer at medium or…
- Trial name
- NCT07890597
- Testing
- Atirmociclib, giredestrant
- Volunteers
- 3,800 people
- Sponsor
- Pfizer
Breast Cancer
Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole
To evaluate safety and efficacy (measured by clinical tumor response) of letrozole daily dose, 2.5 mg in postmenopausal patients with primary (untreated) breast cancer.
- Trial name
- NCT00237224
- Testing
- Letrozole
- Where
- Mexico
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals