Clinical trials: Hormone Receptor Positive Early Breast Cancer
Breast Cancer
Epidemiology and Treatment of HR+/HER2- Breast Cancer in England
The aim of this study was to describe the epidemiology, treatment pathway, treatment access, wastage of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i), and health care resource use among adults with hormone receptor positive…
- Trial name
- ROTOR (NCT07498413)
- Where
- United Kingdom
- Volunteers
- 218,677 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer
RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes.
- Trial name
- SOLE (NCT00553410)
- Testing
- Letrozole
- Where
- 164 sites in United States, Australia and 18 more
- Volunteers
- 4,884 people
- Sponsor
- ETOP IBCSG Partners Foundation
Vaginal Atrophy
A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting
This is a phase II, prospective, randomized, double-blind, placebo-controlled, international (Spain and Sweden) and multicentre study to explore the safety of 0.005% estriol vaginal gel in women with early stage breast cancer in…
- Trial name
- BLISSAFE (NCT02413008)
- Testing
- estriol
- Where
- 6 sites in Spain, Sweden
- Volunteers
- 61 people
- Sponsor
- ITF Research Pharma, S.L.U.
Breast Cancer, Hormone Receptor-positive Breast Cancer
A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC
The 3 FDA-approved CDK4, 6 inhibitors, palbociclib, ribociclib, and abemciclib, all provided progression-free survival benefits when combined with endocrine therapy in advanced ER+/HER2- breast cancer.
- Conditions
- Breast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Therapy
- Trial name
- ORACLE-RIPA (NCT05766410)
- Testing
- Palbociclib, Ribociclib, Abemaciclib
- Where
- 2 sites in Taiwan
- Volunteers
- 60 people
- Sponsor
- National Taiwan University Hospital
Early Breast Cancer
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free…
- Trial name
- Adjuvant WIDER (NCT05827081)
- Testing
- Ribociclib, Letrozole, Ansastrozole
- Where
- 214 sites in United States, Argentina and 14 more
- Volunteers
- 1,466 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer Invasive
NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.
The goal of this clinical study is to learn if serplulimab is effective in early HR+/HER2- breast cancer. This trial serves a prospective parallel control cohort for HELEN-018 (NCT).
- Trial name
- NCT06781281
- Testing
- Serplulimab, NabPE
- Where
- China
- Volunteers
- 709 people
- Sponsor
- Henan Cancer Hospital
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
Breast Cancer
Breast Cancer Index (BCI) Registry
The purpose of the Breast Cancer Index (BCI) Registry study is to conduct a large scale, population-based prospective registry to evaluate long-term clinical outcome, clinical impact, medication adherence and quality of life in…
- Trial name
- NCT04875351
- Testing
- Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Test
- Where
- 105 sites in United States
- Volunteers
- 3,465 people
- Sponsor
- Biotheranostics, Inc.
Breast Cancer, HER2-low-expressing Breast Cancer
Phase II Neoadjuvant Pyrotinib Combined With Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial
This is a single-arm, prospective, non-randomized, single-center, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib combined with epirubicin and cyclophosphamide followed by docetaxel in HR…
- Conditions
- Breast Cancer, HER2-low-expressing Breast Cancer, Hormone Receptor-positive Breast Cancer, Neoadjuvant Therapy
- Trial name
- NCT05165225
- Testing
- Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
Effects of Physical Activity in Early Stage Hormone Receptor Positive Breast Cancer Patients
The advances in early detection coupled with improvements in treatments have led to an ever-increasing number of breast cancer survivors.
- Trial name
- NCT07539038
- Where
- Italy
- Volunteers
- 44 people
- Sponsor
- Centro di Riferimento Oncologico - Aviano
Early-stage Breast Cancer, HER2 Positive Breast Cancer
Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib
A Randomized Phase II Study to Evaluate the Incidence of Discontinuations due to Diarrhoea at 3 Cycles in patients with Early-stage HER2-positive (HER2+), Hormone Receptor-positive (HR+) Breast Cancer treated with Neratinib plus…
- Conditions
- Early-stage Breast Cancer, HER2 Positive Breast Cancer, Hormone Receptor Positive
- Trial name
- DIANER (NCT05252988)
- Testing
- Neratinib, Loperamide, Colesevelam
- Where
- 55 sites in Spain
- Volunteers
- 177 people
- Sponsor
- Spanish Breast Cancer Research Group
Hormone-receptor-positive Breast Cancer, Premenopausal Breast Cancer
Comparative Evaluation of Efficacy and Safety of Toremifene, Tamoxifen, and Aromatase Inhibitor Plus Ovarian Function Suppression in Hormone Receptor-Positive Early Breast Cancer Among Non-Low-Risk Premenopausal Women: A Real-World Study
This study aims to enroll premenopausal patients, with early breast cancer who are non-low-risk and hormone receptor-positive and have undergone prior surgical intervention at the Breast Cancer Center of Sun Yat-sen Memorial…
- Conditions
- Hormone-receptor-positive Breast Cancer, Premenopausal Breast Cancer, Breast Cancer Patients at Intermediate to High Risk, Ovarian Function Suppression Combined With Aromatase Inhibitor or Tamoxifen or Torimefen
- Trial name
- NCT05801705
- Testing
- Aromatase inhibitor, ovarian function suppression (Oophorectomy, Ovarian irradiation, Gonadotropin-releasing hormone agonist), Tamoxifen
- Where
- China
- Volunteers
- 700 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer Females
A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for Hormone Receptor-positive(HR+) Premenopausal Breast Cancer
The goal of this observational study is to observe the long-term prognosis of patients with early HR-positive premenopausal breast cancer.
- Trial name
- NCT07180914
- Volunteers
- 300 people
- Sponsor
- Zhejiang Cancer Hospital
Breast Cancer
Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer
It suggests in the Guideline that the postmenopausal women with breast cancer who have taken selective estrogen receptor modulators (SERMs) therapy for 2-3 years could benefit from changing endocrine therapy to aromatase…
- Trial name
- NCT02097459
- Testing
- Anastrozole, Tamoxifen, Toremifene
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Peking Union Medical College Hospital
Early-stage Breast Cancer
Study of Quality of Life and Hormone Levels in Premenopausal Participants With Early Breast Cancer Receiving Triptorelin Plus Additional Cancer Treatment
The main purpose of this study is to evaluate the quality of life of premenopausal participants with Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor-2 (HER2) negative breast cancer who are receiving, in…
- Trial name
- ROSE (NCT05377684)
- Where
- 22 sites in Italy
- Volunteers
- 450 people
- Sponsor
- Ipsen
Early-stage Breast Cancer
Randomized Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal Receptor-positive Patients
Primarily, this clinical investigation compared the efficacy of tamoxifen + aminoglutethimide vs. tamoxifen alone in terms of prognosis (overall survival) in postmenopausal patients with potentially curative, operated hormone…
- Trial name
- NCT00309491
- Testing
- Tamoxifen alone, Tamoxifen + Aminoglutethimide
- Volunteers
- 2,021 people
- Sponsor
- Austrian Breast & Colorectal Cancer Study Group
Breast Cancer
Serplulimab Plus Chemotherapy for Early-stage HR+/HER2- Breast Cancer
The goal of this clinical trial is to learn if serplulimab is effective in early HR+/HER2- breast cancer. It will also learn about the safety of serplulimab.
- Trial name
- NCT06394661
- Testing
- Serplulimab+NabPE
- Where
- China
- Volunteers
- 109 people
- Sponsor
- Henan Cancer Hospital
HR+/HER2- Early Breast Cancer
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer
The goal of this observational study is to evaluate how persistently patients with high-risk early breast cancer take abemaciclib 6 months after therapy start.
- Trial name
- PROSPER (NCT07531693)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Institut fuer Frauengesundheit
Hormone Receptor Positive HER-2 Negative Breast Cancer
Impact of Endocrine Therapy, Menstrual Cycle, PAM50, Ki67 on Treatment Decisions in HR+ and HER2- Breast Cancer
PEAK is a prospective, multicenter, non-interventional investigator-initiated trial (IIT) that aims to investigate the influence of the menstrual cycle phase on Ki67 in patients who either receive Tamoxifen, Aromatase inhibitors…
- Trial name
- NCT05878314
- Where
- Germany
- Volunteers
- 504 people
- Sponsor
- University Hospital Tuebingen
Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer
ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer
This is a Phase II, multicenter, randomized clinical trial evaluating a ctDNA-guided approach to de-escalate adjuvant chemotherapy in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer.
- Conditions
- Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer, Early-Stage Breast Cancer, HER2-negative Breast Cancer
- Trial name
- DNADalHR (NCT06970912)
- Testing
- Dalpiciclib + Aromatase Inhibitor with ctDNA-Guided Therapy, Taxane-Based Neoadjuvant Chemotherapy
- Where
- China
- Volunteers
- 393 people
- Sponsor
- Peking University People's Hospital