Clinical trials: Estrogen Receptor Negative
Breast Neoplasms, Carcinoma, Ductal, Breast
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Receptors, Estrogen (for ER-positive Requirement)
- Trial name
- SIGNAL-ER 101 (NCT07214532)
- Testing
- ctDNA-Guided Treatment Strategy
- Where
- 49 sites in United States
- Volunteers
- 725 people
- Sponsor
- Natera, Inc.
Pigmentation, Gingiva
Post Gingival Depigmentation Assessment: Comparison of Surgical Stripping vs (Er,Cr:YSGG) Laser
The appearance and health of the gingiva significantly contribute to an aesthetically pleasing smile. Pink gingiva indicates healthy gums and is generally preferred over dark or mixed colors.
- Trial name
- NCT06075641
- Testing
- Gingival depigmentation
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- King Abdulaziz University
Breast Cancer
Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen…
- Trial name
- AMEERA-5 (NCT04478266)
- Testing
- SAR439859, Palbociclib, Letrozole
- Where
- 249 sites in United States, Argentina and 28 more
- Volunteers
- 1,068 people
- Sponsor
- Sanofi
Schizophrenia, Schizoaffective Disorder
A Study of QT and QTc Intervals in Patients Administered Extended Release Paliperidone or Quetiapine
The purpose of this study is to 1) determine whether the effect on QT interval corrected (QTcLD) for heart rate using the population specified linear derived method at steady state is comparable between 12 mg paliperidone…
- Trial name
- NCT00791622
- Testing
- Paliperidone ER
- Volunteers
- 110 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Schizophrenia
A Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug
The purpose of this study is to compare the patient satisfaction between continued administration of previous antipsychotics versus switched administration to paliperidone ER in non-satisfied patients with previous (paliperidone)
- Trial name
- NCT01592201
- Testing
- Paliperdidone ER, Aripiprazole, olanzapine and risperidone (Antipsychotics)
- Where
- 9 sites in South Korea
- Volunteers
- 13 people
- Sponsor
- Janssen Korea, Ltd., Korea
Breast Cancer, Metastatic Breast Cancer
2nd Line Treatment With Pemetrexed and Sorafenib for Recurrent or Metastatic Triple Negative Breast Cancer
This phase 2 clinical trial will evaluate the efficacy of the combination of pemetrexed and sorafenib in patients with recurrent or metastatic Triple Negative Breast Cancer (TNBC).
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT02624700
- Testing
- Experimental Arm A: Pemetrexed, Experimental Arm A: Sorafenib, Experimental Arm B: Pemetrexed
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Virginia Commonwealth University
Major Depressive Disorder
Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)
This is a phase 3, flexible-dose, open-label, multi-center study. The subjects who complete the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate in this study.
- Trial name
- NCT01485887
- Testing
- Venlafaxine ER
- Where
- 25 sites in Japan
- Volunteers
- 50 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Alcohol Abuse
Brief Intervention for Families of Teens Treated in the Emergency Department for an Alcohol-Related Event
The purpose of this study is to compare the effectiveness of a brief family intervention in reducing alcohol use and alcohol-related problems among families of underage drinkers (13-17 years old) who are treated in a hospital…
- Trial name
- NCT00247221
- Testing
- MI/Family Check-up, MI only
- Where
- United States
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Brown University
HER2-positive Breast Cancer, ER-positive Breast Cancer
Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy
Hormonal therapy administered before surgery in ER-positive and HER2-positive patients with breast cancer.
- Trial name
- Neohttp (NCT02345772)
- Testing
- fulvestrant 500 mg, Docetaxel, Trastuzumab (H, 8mg/kg
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Western Regional Medical Center
Breast Cancer, Solid Tumors, Adult
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid…
- Trial name
- PIKALO-1 (NCT05768139)
- Testing
- STX-478, Fulvestrant, Ribociclib
- Where
- 65 sites in United States, Belgium and 7 more
- Volunteers
- 880 people
- Sponsor
- Eli Lilly and Company
Healthy
Food Study Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR 500 mg
The objective of this study is to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administered under…
- Trial name
- NCT00648492
- Testing
- Metformin Hydrochloride ER Tablets 500 mg, Glucophage® XR 500 mg
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
ER-positive Breast Cancer, HER2-negative Breast Cancer
Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study)
A phase II single-arm trial of onapristone in combination with fulvestrant for women and men with ER-positive, PgR-positive or negative and HER2-negative locally advanced or metastatic breast cancer after progression on aromatase…
- Conditions
- ER-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Cancer
- Trial name
- NCT04738292
- Testing
- Onapristone, Fulvestrant
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- University of Wisconsin, Madison
Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with…
- Trial name
- NCT04546009
- Testing
- Giredestrant, Letrozole, Palbociclib
- Where
- 255 sites in United States, Argentina and 28 more
- Volunteers
- 992 people
- Sponsor
- Hoffmann-La Roche
Hot Flashes
Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
Depomed's Gabapentin Extended Release is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.
- Trial name
- NCT00511953
- Testing
- Gabapentin Extended Release tablets, Gabapentin
- Where
- 8 sites in United States
- Volunteers
- 108 people
- Sponsor
- Depomed
Attention Deficit Hyperactivity Disorder
Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHD
This study will evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD.
- Trial name
- NCT06431256
- Testing
- HLD200 methylphenidate hydrochloride capsules
- Where
- 13 sites in United States
- Volunteers
- 26 people
- Sponsor
- Ironshore Pharmaceuticals and Development, Inc
Aging
Transcriptomic Study of ER 4017 Topical Application in Elderly Subject
The stratum corneum (SC) is the superficial layer of the epidermis situated at the interface between the body and its outside environment. Its strategic position confers it a crucial role of protection against aggressions.
- Trial name
- NCT00818545
- Testing
- ER4017 (hydroxypropyltetrahydropyrantriol)
- Where
- France
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- L'Oreal
Breast Cancer, Infertility
Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer
RATIONALE: Goserelin may help prevent early menopause in patients undergoing chemotherapy for breast cancer. It is not yet known whether goserelin is effective in preventing early menopause in women undergoing chemotherapy for…
- Conditions
- Breast Cancer, Infertility, Menopausal Symptoms
- Trial name
- NCT00427245
- Testing
- cyclophosphamide, goserelin acetate, adjuvant therapy
- Where
- 66 sites in United Kingdom
- Volunteers
- 400 people
- Sponsor
- Anglo Celtic Cooperative Oncology Group
Depression, Major Depressive Disorder
Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder
The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).
- Trial name
- NCT01085812
- Testing
- Levomilnacipran ER
- Where
- 35 sites in United States, Canada
- Volunteers
- 734 people
- Sponsor
- Forest Laboratories
Brest Cancer ER+ and HER2 Negative
De-EscaLaTion of Aromatase Inhibitor Therapy: A Randomized Phase II Study of De-escalated Letrozole in Hormone Receptor-Positive Early Breast Cancer
This study is a randomized, open-label, phase II trial designed to evaluate whether alternate-day dosing of letrozole preserves antiproliferative activity compared with standard daily dosing in postmenopausal women with estrogen…
- Trial name
- DELTA (NCT07866430)
- Testing
- Letrozole
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- Montefiore Medical Center
Breast Carcinoma Metastatic in the Brain, Estrogen Receptor Negative
Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis
The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor activity against the breast cancer that has spread to the brain and also to determine the overall radiographic response rate in the CNS.
- Conditions
- Breast Carcinoma Metastatic in the Brain, Estrogen Receptor Negative, HER2/Neu Negative, HER2/Neu Positive
- Trial name
- NCT02774681
- Testing
- Cognitive Assessment, Palbociclib, Quality-of-Life Assessment
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Northwestern University