Clinical trials: Early Hormone Receptor-positive Breast Cancer
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
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer
To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in…
- Trial name
- NCT06038539
- Testing
- PERT-IJS plus trastuzumab, carboplatin and docetaxel, Perjeta plus trastuzumab, carboplatin and docetaxel
- Where
- India
- Volunteers
- 55 people
- Sponsor
- Biocon Biologics UK Ltd
Hormone Receptor Positive Early Breast Cancer
A Study to Compare the Steady-State Bioavailability of Injectable Letrozole SIE and Oral Letrozole in Post-Menopausal Women With Hormone Receptor Positive Early Breast Cancer
The study aims to compare the amount of the drug letrozole that gets into the bloodstream after multiple doses of the quarterly injection Letrozole SIE, versus multiple doses of the standard oral daily tablet of letrozole…
- Trial name
- SIE-1 (NCT07401381)
- Testing
- US-sourced oral Femara® + Letrozole SIE, EU sourced oral Femara® + Letrozole SIE
- Where
- 21 sites in United States, Serbia and 1 more
- Volunteers
- 120 people
- Sponsor
- Rovi Pharmaceuticals Laboratories
Breast Cancer
RADIANT: Pre-op Radiation With Abemaciclib and Letrozole
This phase 1b study investigates the safety and feasibility of combining pre-operative radiation therapy with Cyclin-Dependent Kinase 4 (CDK4/6) inhibitors in participants with hormone receptor positive/HER2 negative (HR+/HER2-)…
- Trial name
- NCT06139107
- Testing
- Abemaciclib, Letrozole
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Mridula George, MD
Leucogen, Ribociclib
the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast Cancer
This study is a multicenter, single-arm, open-label Phase II exploratory clinical trial designed to evaluate whether prophylactic use of leucogen can reduce the incidence of Grade 3 or higher neutropenia in early-stage HR+/HER2…
- Conditions
- Leucogen, Ribociclib, Neutropenia (Low White Blood Cell Count), Breast Cancer
- Trial name
- NCT07380646
- Testing
- Treat Regimen
- Where
- China
- Volunteers
- 97 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Early-Stage Breast Carcinoma, Hormone Receptor Positive Tumor
Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors
The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of the cdk 4/6 inhibitor palbociclib when added to standard endocrine treatment. Initially, patients receive endocrine treatment for 4 weeks.
- Trial name
- PREDIX LumA (NCT02592083)
- Testing
- Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin, Palbociclib
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Thomas Hatschek
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.
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
- 1,464 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Musculoskeletal Complications
S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy
RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone…
- Conditions
- Breast Cancer, Musculoskeletal Complications, Pain
- Trial name
- NCT01598298
- Testing
- duloxetine hydrochloride
- Where
- 714 sites in United States
- Volunteers
- 299 people
- Sponsor
- SWOG Cancer Research Network
Breast Neoplasm Female, Stage I Breast Cancer
Biomarker Study of the Antitumoral Activity of Denosumab in the Pre- Operative Setting of Early Breast Cancer
This is a biomarker study designed to test the preclinically generated hypothesis of anti-tumoral activity of denosumab in patients with early breast cancer candidates a tumour excision
- Conditions
- Breast Neoplasm Female, Stage I Breast Cancer, Stage II Breast Cancer, Hormone Receptor Negative Neoplasm
- Trial name
- D-BIOMARK (NCT03691311)
- Testing
- Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Institut Català d'Oncologia
Arthralgia, Breast Cancer
S0927:Omega3-Fatty Acid Supp in Treating Muscle&Bone Pain&Stiffness in Pts W/Stg I,II,III Brst Canc Rec'v Hormone Thpy
RATIONALE: An omega-3 fatty acid-enriched nutritional supplement may help improve muscle and bone pain and stiffness caused by hormone therapy in patients with breast cancer.
- Conditions
- Arthralgia, Breast Cancer, Pain
- Trial name
- NCT01385137
- Testing
- omega-3 fatty acid
- Where
- 292 sites in United States
- Volunteers
- 262 people
- Sponsor
- SWOG Cancer Research Network
Breast Cancer Female, Locally Advanced Breast Cancer
Neoadjuvant Study of Abemaciclib, Durvalumab, and an Aromatase Inhibitor Early Stage Breast Cancer
The purpose of this study is to test the efficacy, safety and tolerability of a combination of immunotherapy and anticancer drugs presurgery in patients with hormone-receptor positive breast cancer.
- Conditions
- Breast Cancer Female, Locally Advanced Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast
- Trial name
- NCT04088032
- Testing
- Abemaciclib, durvalumab and aromatase inhibitor
- Where
- United States
- Sponsor
- Alison Stopeck
Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer
Phase III Study ：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative
The study is to evaluate the efficacy and safety of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative.
- Trial name
- NCT04842617
- Testing
- SHR6390
- Where
- China
- Volunteers
- 5,274 people
- Sponsor
- Jiangsu HengRui Medicine 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
Phase 0 Study of Metronomic Oral Vinorelbine and Letrozole in HR+/HER2-negative Early Breast Cancer Patients (VENTANA)
VENTANA is a "window-of-opportunity" trial that will explore whether, similar to CDK4/6 inhibitors, Oral Metronomic Vinorelbine in combination with Letrozole induces a superior anti-proliferative effect than Letrozole alone.
- Trial name
- NCT02802748
- Testing
- Oral Vinorelbine, Letrozole
- Where
- 10 sites in Spain
- Volunteers
- 60 people
- Sponsor
- SOLTI Breast Cancer Research Group
Early Breast Cancer, Hormone Receptor Positive Tumor
Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer
Around 90% of breast cancer patients are diagnosed at an early stage and approximately 70% are hormone receptor-positive and HER2-negative (HR+/HER2-).
- Conditions
- Early Breast Cancer, Hormone Receptor Positive Tumor, HER2-negative Breast Cancer
- Trial name
- ONCO-Adher (NCT06650423)
- Where
- Slovenia
- Volunteers
- 319 people
- Sponsor
- Institute of Oncology Ljubljana
Breast Cancer Female, Endocrine Therapy
The Benefits of Continued Use of Ovarian Function Suppression After 5 Years
To observe and evaluate the clinical efficacy and safety of continuous use of OFS for premenopausal patients with early breast cancer after 5 years use of OFS.
- Trial name
- NCT06050109
- Testing
- OFS continues to use group after 5 years use, Immunohistochemical detection of HR status
- Where
- China
- Volunteers
- 1,200 people
- Sponsor
- Hongmei Zheng, PhD
Breast Cancer Stage III, Breast Cancer Stage II
The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment
To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer.
- Trial name
- NCT06810492
- Testing
- Ribociclib; abemaciclib; palbociclib; Dalpiciclib
- Volunteers
- 40 people
- Sponsor
- Hongmei Zheng, PhD
Breast Cancer Invasive, Hormone-receptor-positive Breast Cancer
Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer
This is a multi-center, open-lable, prospective, randomized phase III clinical trial to further validate the efficacy and safety of neoadjuvant pyrotinib combined with chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative)…
- Conditions
- Breast Cancer Invasive, Hormone-receptor-positive Breast Cancer, HER2 Low Breast Carcinoma, Early-stage Breast Cancer
- Trial name
- NCT06144944
- Testing
- Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel, Epirubicin or doxorubicin, cyclophosphamide, paclitaxel
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer
The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles.
- Trial name
- SABRE (NCT00082277)
- Testing
- Anastrozole, Risedronate Sodium
- Where
- 35 sites in United States, Canada and 6 more
- Volunteers
- 237 people
- Sponsor
- AstraZeneca