Clinical trials: ER-positive Breast Cancer
ER+ HER2- Advanced Breast Cancer
A Phase 1 Study of AZD9833 in Japanese Women With ER Positive, HER2 Negative Advanced Breast Cancer
This is a Phase 1, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AZD9833 in Japanese women with endocrineresistant ER+ HER2- breast cancer that is not amenable to…
- Trial name
- NCT04541433
- Testing
- AZD9833
- Where
- 3 sites in Japan
- Volunteers
- 10 people
- Sponsor
- AstraZeneca
Breast Cancer
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment…
- Trial name
- COMPLEEMENT-1 (NCT02941926)
- Testing
- Ribociclib, Letrozole, Goserelin
- Where
- 495 sites in United States, Argentina and 36 more
- Volunteers
- 3,246 people
- Sponsor
- Novartis Pharmaceuticals
Healthy Volunteers
A Study to Assess the Rel Bioavailability, Food Effect and Absolute Bioavailability on the Pharmacokinetics of AZD9833
AstraZeneca AB is developing the test medicine, AZD9833, for the potential treatment of oestrogen receptor (ER) positive breast cancer.
- Trial name
- NCT04546347
- Testing
- [14C]AZD9833 Solution for Infusion, (NMT 22.8 kBq/5mL), AZD9833 film-coated tablet A Dose 1, AZD9833 Oral Solution
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Advanced Solid Tumor, Metastatic Breast Cancer
A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
This is a multicenter, open label, nonrandomized, sequential dose escalation/dose ranging, multiple dose study designed to evaluate the safety, toxicity, and PK as well as preliminary efficacy of BTX-A51 alone and in combination…
- Trial name
- NCT04872166
- Testing
- BTX-A51
- Where
- 6 sites in United States
- Volunteers
- 112 people
- Sponsor
- Edgewood Oncology Inc.
Breast Cancer
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). In preclinical studies, it demonstrated strong activity against PI3K p110α in vitro and in vivo, and inhibited tumor cell…
- Trial name
- NCT04631835
- Testing
- HS-10352
- Where
- 3 sites in China
- Volunteers
- 54 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Breast Cancer, Locally Advanced Breast Cancer
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
- Conditions
- Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer
- Trial name
- OPERA-02 (NCT07085767)
- Testing
- Palazestrant, Ribociclib, Letrozole
- Where
- 200 sites in United States, Australia and 21 more
- Volunteers
- 1,000 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Metastatic Breast Cancer, ER-positive Breast Cancer
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
This is a Phase 1b open-label, 2-part study in 4 treatment groups. The 4 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).
- Conditions
- Metastatic Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05508906
- Testing
- Palazestrant, Ribociclib, Alpelisib
- Where
- 16 sites in United States, Australia
- Volunteers
- 190 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Breast Neoplasms
Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer
This non-interventional study will be conducted in several Eastern European countries to assess the safety, tolerability and efficacy of Aromasin® when it is administered in real-word setting in postmenopausal women with invasive…
- Trial name
- NCT01239745
- Testing
- Aromasin
- Where
- 11 sites in Croatia, Estonia and 1 more
- Volunteers
- 46 people
- Sponsor
- Pfizer
Breast Cancer
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.
In the phase I part, to determine the recommended doses (RD) and dosing regimens of [177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive…
- Trial name
- NeoB-Cap1 (NCT06247995)
- Testing
- [68Ga]Ga-NeoB, [177Lu]Lu-NeoB, Capecitabine
- Where
- 28 sites in United States, Australia and 11 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasm
SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer
This is a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant.
- Trial name
- STEM (NCT02970682)
- Testing
- SFX-01, Fulvestrant, Tamoxifen
- Where
- 10 sites in Belgium, France and 2 more
- Volunteers
- 60 people
- Sponsor
- Evgen Pharma
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
Metastatic Breast Cancer
4EVER - Efficacy, Safety, Health Economics, Translational Research of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer
The present multi-center, open-label, single-arm study aims to evaluate the efficacy and safety, quality of life and health resources utilization in postmenopausal women with hormone receptor positive breast cancer progressing…
- Trial name
- MACS2096 (NCT01626222)
- Testing
- Exemestane, Everolimus (RAD001)
- Where
- 84 sites in Germany
- Volunteers
- 301 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer
The progression free survival and efficacy of 250 mg ZD1839 in combination with a fixed dose of fulvestrant 250 mg im once a month will be evaluated in female patients with histologically-confirmed advanced or metastatic, ER…
- Trial name
- NCT00234403
- Testing
- gefitinib and fulvestrant
- Where
- 7 sites in Spain
- Volunteers
- 60 people
- Sponsor
- AstraZeneca
Breast Cancer
Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive and Estrogen Receptor/Progesterone Receptor Negative Breast Cancer to Evaluate the Efficiency and Safety of Treatment With Trastuzumab Plus (+) QL1209/Pertuzumab + Docetaxel.
This is a randomized, double-blind, multicenter trial，parallel control designed to evaluate treatment with trastuzumab + QL1209 + docetaxel compared with trastuzumab + pertuzumab + docetaxel in the participants with early-stage…
- Trial name
- NCT04629846
- Testing
- Trastuzumab, QL1209, Pertuzumab
- Where
- 2 sites in China
- Volunteers
- 517 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Breast Neoplasms
Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer
This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or…
- Trial name
- NCT00073528
- Testing
- Lapatinib, Letrozole
- Where
- 278 sites in United States, Argentina and 27 more
- Volunteers
- 1,286 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal…
- Trial name
- SOLAR-1 (NCT02437318)
- Testing
- Fulvestrant, Alpelisib
- Where
- 197 sites in United States, Argentina and 29 more
- Volunteers
- 572 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of ZN-c5 in Subjects With Breast Cancer
This is a Phase 1/2, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-c5 administered orally in subjects with advanced estrogen…
- Trial name
- NCT03560531
- Testing
- ZN-c5, Palbociclib
- Where
- 38 sites in United States, Belarus and 7 more
- Volunteers
- 181 people
- Sponsor
- Zeno Alpha Inc.
Breast Cancer
Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer
The purpose of this study is to determine if enzalutamide given in combination with exemestane is safe and effective in patients with advanced breast cancer.
- Trial name
- NCT02007512
- Testing
- Enzalutamide, exemestane
- Where
- 135 sites in United States, Belgium and 5 more
- Volunteers
- 247 people
- Sponsor
- Pfizer
Breast Cancer
Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients
This multicenter, prospectively designed study examines whether the Prosigna score influences physician and patient adjuvant treatment selection over and above currently used prognostic factors.
- Trial name
- NCT02625935
- Where
- 4 sites in United States
- Volunteers
- 206 people
- Sponsor
- NanoString Technologies, Inc.
Breast Cancer, Breast Carcinoma
Study to Compare Alisertib With Paclitaxel vs. Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer
The goal of this clinical research study is to learn if the study drug, alisertib (MLN8237), in combination with chemotherapy (paclitaxel), can shrink or slow tumor growth in women with hormone receptor (HR)-positive, human…
- Conditions
- Breast Cancer, Breast Carcinoma, Breast Tumors, Malignant Neoplasm of Breast
- Trial name
- NCT02187991
- Testing
- Paclitaxel, Alisertib
- Where
- United States
- Volunteers
- 169 people
- Sponsor
- US Oncology Research