Clinical trials: Hormone Receptor (HR)-Positive Breast Cancer
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.
Advanced Breast Cancer, Metastatic Breast Cancer
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
NUV-422-03 is a randomized, non-comparative Phase 1/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant…
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, Breast Cancer, Breast Carcinoma
- Trial name
- NCT05191004
- Testing
- NUV-422, Fulvestrant
- Where
- 5 sites in United States
- Sponsor
- Nuvation Bio Inc.
Breast Cancer Female, HER2-positive Breast Cancer
Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer
This study is a single-arm, open-label, phase II study, comparing the efficacy and safety of pyrotinib plus trastuzumab and aromatase inhibitors, in the treatment of HR (hormone receptor)+/HER2 (human epidermal growth factor…
- Conditions
- Breast Cancer Female, HER2-positive Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, Metastatic Breast Cancer
- Trial name
- NCT04088110
- Testing
- Pyrotinib, Trastuzumab, Aromatase Inhibitors
- Where
- China
- Volunteers
- 77 people
- Sponsor
- Fuzhou General Hospital
Locally Advanced (Inoperable) or Metastatic Breast Cancer
Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
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…
- Trial name
- CAPItello-292 (NCT04862663)
- Testing
- Capivasertib, Fulvestrant, Palbociclib
- Where
- 225 sites in United States, Argentina and 21 more
- Volunteers
- 893 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
Metastatic Breast Cancer
Pyrotinib in Combination With Fulvestrant in Patients With HER2 Positive，HR-Positive Metastatic Breast Cancer
HR+/HER2+（Human epidermal growth factor receptor 2 positive and hormone receptor positive）metastatic breast cancer is a special subtype of HER2+breast cancer.
- Trial name
- NCT04034589
- Testing
- Pyrotinib combined with fulvestrant
- Where
- 2 sites in China
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Obesity (Disorder), Breast Cancer
Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors
This study will explore whether tirzepatide is a practical and acceptable treatment for postmenopausal females with a history of hormone receptor-positive breast cancer and obesity.
- Trial name
- NCT07257484
- Testing
- Tirzepatide
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Weill Medical College of Cornell University
Breast Cancer
A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer
The researcher are doing this study to find out whether benralizumab is effective at preventing skin rashes caused by alpelisib in people who have metastatic breast cancer. Skin rash is a common side effect of alpelisib.
- Trial name
- NCT05966584
- Testing
- Benralizumab, fulvestrant or AIs) and PI3K inhibition (alpelisib)
- Where
- 7 sites in United States
- Volunteers
- 1 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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.
HR+ / HER2- Advanced Breast Cancer
A Study of SH3765 Tablets in Combination With Fulvestrant in Patients With HR+/HER2- Advanced Breast Cancer.
Evaluate the efficacy and safety of the SH3765 tablet combined with fulvestrant in the treatment of patients with advanced HR-positive breast cancer
- Trial name
- NCT07557004
- Testing
- SH3765+Fulvestrant
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
Locally Advanced Breast Cancer, Hormone Receptor Positive，HER2-negative Breast Cancer
Select the Appropriate Population for Adding CDK4/6i to Neoadjuvant Endocrine Therapy
Select the appropriate population for adding CDK4/6 inhibitors therapy in high risk early HR+/HER2-breast cancer based on molecular detection
- Trial name
- NCT05809024
- Testing
- letrozole
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Yongsheng Wang
Breast Cancer, Breast Carcinoma
A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer
The purpose of this clinical study is to describe the patient population, breast cancer treatment, and breast cancer treatment results of adult female patients who have received palbociclib combination treatments for advanced or…
- Conditions
- Breast Cancer, Breast Carcinoma, Breast Neoplasms, Breast Tumors
- Trial name
- NCT05584644
- Testing
- Palbociclib plus hormonal treatment - first line treatment, Palbociclib plus hormonal treatment - second line treatment
- Where
- 6 sites in India
- Volunteers
- 150 people
- Sponsor
- Pfizer
HER2-positive Breast Cancer
Anti-HER2 Therapy + Fulvestrant/Capecitabine in Women With HR+, HER2+, Non-visceral Metastases Stage IV Breast Cancer
The purpose of this study is to evaluate the effectiveness of anti-HER2 therapy plus Fulvestrant or Capecitabine in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+)…
- Trial name
- FAVOR (NCT04337658)
- Testing
- Pertuzumab, Trastuzumab, Fulvestrant
- Where
- 2 sites in China
- Volunteers
- 493 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Breast Cancer, Hormone-receptor Positive Breast Cancer
Pyrotinib Plus Neoadjuvant Chemotherapy in HR+/HER2-, HER4-High Breast Cancer
This is a Phase II, single-center, double-blind, placebo-controlled, randomized study of Pyrotinib in combination with Doxorubicin/Epirubicin and Cyclophosphamide followed by Docetaxel/nab-Paclitaxel as neoadjuvant therapy for…
- Trial name
- NCT04872985
- Testing
- Pyrotinib, Epirubicin, Doxorubicin Hydrochloride Liposome Injection
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
HER2-positive Breast Cancer, HER2 Low
ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer
This is an open-label, single-arm, multi-site phase I/Ib trial with SYD985, an antibody-drug conjugate (ADC) targeting HER2 on the cell membrane, combined with paclitaxel.
- Conditions
- HER2-positive Breast Cancer, HER2 Low, SYD-985, SYD985
- Trial name
- NCT04602117
- Testing
- Vic-trastuzumab duocarmazine (SYD985) + paclitaxel
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- QuantumLeap Healthcare Collaborative
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Malignant Neoplasm in the Brain
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
This phase IIa trial studies how well dendritic cell vaccines against Her2/Her3 and pembrolizumab work for the treatment of triple negative breast cancer or HER2+ breast cancer or HER+ Breast cancer that has spread to the brain…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Malignant Neoplasm in the Brain, Metastatic Triple-Negative Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
- Trial name
- NCT04348747
- Testing
- Anti-HER2/HER3 Dendritic Cell Vaccine, Pembrolizumab
- Where
- 3 sites in United States
- Volunteers
- 23 people
- Sponsor
- Roswell Park Cancer Institute
Estrogen Receptor Positive, Progesterone Receptor Positive
Alisertib and Fulvestrant in Treating Patients With Hormone Receptor Positive Breast Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery
This phase I trial studies the side effects and best dose of alisertib when given together with fulvestrant in treating patients with hormone positive breast cancer that has spread to other parts of the body or has spread from…
- Conditions
- Estrogen Receptor Positive, Progesterone Receptor Positive, Recurrent Breast Carcinoma, Stage IIIB Breast Cancer
- Trial name
- NCT02219789
- Testing
- Alisertib, Fulvestrant, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Mayo Clinic
HR+ HER2- Breast Cancer
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants…
- Trial name
- NCT07558733
- Testing
- Serabelisib, Sapanisertib, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Faeth Therapeutics
Fasting Mimicking Diet, HER2-negative Breast Cancer
Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in Hormone Receptor Postive (HR+), HER2- Breast Cancer
In preclinical research, short-term fasting (STF) protects tumor-bearing mice against the toxic effects of chemotherapy, improves the CD8+ effector T-cell intratumor infiltration, while enhancing the chemotherapy efficacy.
- Conditions
- Fasting Mimicking Diet, HER2-negative Breast Cancer, Hormone Receptor-positive Breast Cancer, Pathological Complete Response
- Trial name
- DIRECT-2 (NCT05503108)
- Testing
- Fasting Mimicking diet program
- Where
- 7 sites in Netherlands
- Volunteers
- 10 people
- Sponsor
- Leiden University Medical Center
Early Breast Cancer, Adjuvant Therapy
Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients
This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast…
- Conditions
- Early Breast Cancer, Adjuvant Therapy, Hormone Receptor Positive / HER2-negative Breast Cancer
- Trial name
- NCT07101159
- Testing
- Dalpiciclib, Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
- Volunteers
- 200 people
- Sponsor
- Fujian Cancer Hospital