Clinical trials: Hormone Receptor Positive Tumor
Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced and/or metastatic hormone receptor…
- Trial name
- NCT04505826
- Testing
- OP-1250
- Where
- 19 sites in United States, Australia
- Volunteers
- 153 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Metastatic Breast Cancer
Phase II Study of GTx024 in Women With Metastatic Breast Cancer
The primary efficacy analysis will be the clinical benefit at 6 months as measured by a modified Response Evaluation Criteria in Solid Tumors RECIST classification.
- Trial name
- NCT01616758
- Testing
- GTx-024 9mg
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- GTx
Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC)
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical ([225Ac]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors…
- Conditions
- Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer
- Trial name
- NCT07020117
- Testing
- [225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)
- Where
- 14 sites in United States
- Volunteers
- 150 people
- Sponsor
- Aktis Oncology, Inc.
Vulvar Adenocarcinoma, PDAC - Pancreatic Ductal Adenocarcinoma
AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that…
- Conditions
- Vulvar Adenocarcinoma, PDAC - Pancreatic Ductal Adenocarcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma
- Trial name
- FOCUS-01 (NCT07454642)
- Testing
- AVA6103
- Where
- 7 sites in United States
- Volunteers
- 174 people
- Sponsor
- Avacta Life Sciences Ltd
Breast Cancer
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal…
- Trial name
- NCT05384119
- Testing
- TTI-101, Palbociclib, Aromatase inhibitor (AI)
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Tvardi Therapeutics, Incorporated
Breast Neoplasms, Neoplasms, Hormone-Dependent
The CAT Study: Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another…
- Trial name
- NCT00097344
- Testing
- Atamestane, Toremifene, Letrozole
- Where
- 104 sites in United States, Bulgaria and 3 more
- Volunteers
- 842 people
- Sponsor
- Intarcia Therapeutics
Advanced Hormone Receptor Positive (HR+) Breast Cancer
MAP Treatment Plan With Afinitor for Postmenopausal Women With Advanced HR+ Breast Cancer
The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide guidance to the Physician for the treatment and monitoring of patients in the Cohort MAP.
- Trial name
- NCT05108740
- Testing
- everolimus
- Sponsor
- Novartis Pharmaceuticals
Solid Tumor, TNBC - Triple-Negative Breast Cancer
TH1902 in Patients With Advanced Solid Tumors
Open label first-in-human study of TH1902 in solid cancer, with 4 sequential parts: Part 1 (dose escalation): patients with recurrent advanced solid tumors (all comers) that have relapsed or are refractory to standard…
- Conditions
- Solid Tumor, TNBC - Triple-Negative Breast Cancer, Hormone Receptor-positive Breast Cancer, Epithelial Ovarian Cancer
- Trial name
- NCT04706962
- Testing
- TH1902
- Where
- 6 sites in United States, Canada
- Volunteers
- 70 people
- Sponsor
- Theratechnologies
Breast Cancer
Trial of Chidamide in Combination With Exemestane in Patients With Advanced Breast Cancer
This study was to evaluate the efficacy and safety of Chidamide in combination with exemestane in postmenopausal patients with hormone-receptor positive advanced breast cancer.
- Trial name
- NCT02482753
- Testing
- Chidamide, exemestane
- Where
- 22 sites in China
- Volunteers
- 365 people
- Sponsor
- Chipscreen Biosciences, Ltd.
Breast Neoplasms
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib +…
- Trial name
- MONARCH 2 (NCT02107703)
- Testing
- Abemaciclib, Fulvestrant
- Where
- 146 sites in United States, Australia and 18 more
- Volunteers
- 669 people
- Sponsor
- Eli Lilly and Company
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
Study of XB010 in Subjects With Solid Tumors
This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic…
- Conditions
- Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer, Head and Neck Squamous Cell Cancer, NSCLC (Non-small Cell Lung Cancer)
- Trial name
- NCT06545331
- Testing
- XB010, Pembrolizumab
- Where
- 20 sites in United States, United Kingdom
- Volunteers
- 396 people
- Sponsor
- Exelixis
Breast Neoplasms, Neoplasms, Hormone-Dependent
Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer
Protocol 777-CLP-32 is the treatment and survival continuation protocol of Biomed 777-CLP-29, and will continue to compare combined hormonal therapy using the experimental aromatase inhibitor (AI) atamestane combined with the…
- Trial name
- NCT00267553
- Testing
- Atamestane, toremifene, letrozole
- Where
- 35 sites in United States, Canada and 2 more
- Volunteers
- 200 people
- Sponsor
- Intarcia Therapeutics
Breast Neoplasms
Study to Compare Neoadjuvant Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy and Quality of Life Assessment Under Adjuvant Therapy in Operable HER2+/HR+ Breast Cancer Patients
This is a prospective, phase IIa, multicenter, randomized, open-label study comparing a pre-surgical combination of trastuzumab and pertuzumab with concurrent weekly paclitaxel chemotherapy or endocrine therapy given for 12 weeks…
- Trial name
- TP-II (NCT03272477)
- Testing
- Perjeta Injectable Product, Herceptin, Tamoxifen
- Where
- Germany
- Volunteers
- 257 people
- Sponsor
- Palleos Healthcare GmbH
Breast Cancer
A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer
HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10352 plus…
- Trial name
- NCT05504213
- Testing
- HS-10352 combined with fulvestrant (Stage 1), HS-10352 combined with fulvestrant (Stage 2)
- Where
- China
- Volunteers
- 224 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
HR-positive, HER2-negative Breast Neoplasms
To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer
A randomized, double-blind, parallel-controlled, multicenter trial design was used in this study. Subjects who meet the criteria will be randomly divided into 2:1 groups to receive TBQ3616 capsule combined with Fulvestrant…
- Trial name
- NCT05365178
- Testing
- TQB3616 capsule, Fulvestrant injection
- Where
- 88 sites in China
- Volunteers
- 432 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Breast Cancer
ABCSG 8 - Adjuvant Treatment in Patients With Hormone Receptor-positive Breast Cancer With Good to Moderate Differentiation.
The purpose of this study is to assess the difference in event-free survival between postmenopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to…
- Trial name
- NCT00291759
- Testing
- Tamoxifen, Anastrozole
- Where
- 52 sites in Austria
- Volunteers
- 3,858 people
- Sponsor
- AstraZeneca
Breast Cancer
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments
This was a Phase II, multicenter, open-label, three-cohort, non-comparative study of alpelisib plus endocrine therapy (either fulvestrant or letrozole) in subjects (pre- and post-menopausal women and men) with HR-positive…
- Trial name
- BYLieve (NCT03056755)
- Testing
- Alpelisib, Fulvestrant, Letrozole
- Where
- 94 sites in United States, Argentina and 17 more
- Volunteers
- 383 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
- Trial name
- NCT02792725
- Testing
- Abemaciclib
- Where
- 10 sites in United States
- Sponsor
- Eli Lilly and Company
Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- ALISCA-Breast1 (NCT06369285)
- Testing
- Alisertib, Endocrine therapy
- Where
- 53 sites in United States, Portugal and 1 more
- Volunteers
- 225 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Neoplasms, Neoplasm Metastasis
A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with hormone therapy in Indian women with advanced breast cancer.
- Trial name
- NCT04707196
- Testing
- Abemaciclib, Nonsteroidal Aromatase Inhibitor (NSAI), Fulvestrant
- Where
- 15 sites in India
- Volunteers
- 200 people
- Sponsor
- Eli Lilly and Company