Clinical trials: Breast Cancer Stage III
Breast Cancer
A Phase III Clinical Study of HRS-6209 Plus Letrozole as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer
The purpose of this study is to investigate the efficacy and safety of HRS-6209 in combination with letrozole compared with dalpciclib or palbociclib in combination with aromatase inhibitor in patients with advanced or metastatic…
- Trial name
- NCT07894328
- Testing
- HRS-6209 + Letrozole, Dalpciclib/Palbociclib + Letrozole/Anastrozole
- Where
- China
- Volunteers
- 1,050 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
HER2-positive Breast Cancer
Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer
This study was a phase III, multicenter, triple-blind, equivalency clinical trial to determine the therapeutic efficacy and safety between Pertuzumab® (CinnaGen Co.) compared to originator pertuzumab in HER2-positive early breast…
- Trial name
- NCT04957212
- Testing
- Trastuzumab, Pertuzumab, Carboplatin
- Where
- 44 sites in Iran
- Volunteers
- 214 people
- Sponsor
- Cinnagen
Locally Advanced or Metastatic Breast Cancer
GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer
GB491-004 is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of GB491 in combination with fulvestrant in patients with HR-positive, HER2-negative locally advanced or…
- Trial name
- NCT05054751
- Testing
- GB491+ Fulvestrant
- Where
- 54 sites in China
- Volunteers
- 275 people
- Sponsor
- Genor Biopharma Co., Ltd.
Cancer-related Fatigue, Neutropenia, Malignant
PG2 Breast Cancer Evaluation in Adjuvant Medicine Study
Adjuvant chemotherapy usually is recommended after surgery for breast cancer patients who are at significant risk for disseminated disease. Chemotherapy has been demonstrated to reduce the risk of breast cancer recurrence.
- Trial name
- PG2 BEAM (NCT03314805)
- Testing
- Astragalus polysaccharides 500 mg, EC Chemotherapy
- Where
- 5 sites in Taiwan
- Volunteers
- 67 people
- Sponsor
- PhytoHealth Corporation
Breast Cancer Metastatic, BRCA 1 Gene Mutation
Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in…
- Conditions
- Breast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
- Trial name
- OlympiAD (NCT02000622)
- Testing
- Olaparib, Physician's choice chemotherapy
- Where
- 171 sites in United States, Bulgaria and 17 more
- Volunteers
- 302 people
- Sponsor
- AstraZeneca
Breast Cancer
Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.
The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a…
- Trial name
- CONFIRM (NCT00099437)
- Testing
- Fulvestrant
- Where
- 106 sites in United States, Belgium and 15 more
- Volunteers
- 736 people
- Sponsor
- AstraZeneca
Triple Negative Breast Cancer
to Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versus Placebo as Adjuvant Therapy in Patients With Triple Negative Breast Cancer (TNBC)
This study is a randomized, double-Blind,international multi-Centre, phase III clinical study to evaluate efficacy and safety of HLX10 in combination with chemotherapy versus placebo in combination with chemotherapy as…
- Trial name
- NCT04301739
- Testing
- HLX10, nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide
- Volunteers
- 522 people
- Sponsor
- Shanghai Henlius Biotech
Vaginal Atrophy in Breast Cancer Patients
Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced…
- Trial name
- NCT03740945
- Testing
- Prasterone (DHEA)
- Sponsor
- EndoCeutics Inc.
Breast Neoplasms, Fatigue
A Study to Evaluate the Efficacy and Safety of Orally Administered Extract of Orthosiphon Stamineus (NuvastaticTM-C5OSEW5050ESA) in Patient With Breast Cancer Undergoing Chemotherapy
The goal of this clinical trial is to determine whether Nuvastatic™ can reduce cancer-related fatigue and improve quality of life in adult female patients with breast cancer undergoing standard chemotherapy.
- Conditions
- Breast Neoplasms, Fatigue, Quality of Life, Chemotherapy, Adjuvant
- Trial name
- NuvastaticTM (NCT07669506)
- Testing
- Nuvastatic ™
- Where
- 7 sites in India
- Volunteers
- 180 people
- Sponsor
- Natureceuticals Sdn Bhd
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
Breast Cancer, Breast Neoplasms
A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer
This is a phase III, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of pertuzumab biosimilar HLX11 vs.
- Conditions
- Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer
- Trial name
- NCT05346224
- Testing
- HLX11, EU-Perjeta®
- Where
- 79 sites in China, Hungary and 2 more
- Volunteers
- 900 people
- Sponsor
- Shanghai Henlius Biotech
HER2-positive Early Breast Cancer
A Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese Participants With HER2-Positive Early Breast Cancer
This study will evaluate the pharmacokinetics, efficacy, and safety of the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) as compared with those of the pertuzumab intravenous (IV)…
- Trial name
- NCT04024462
- Testing
- Pertuzumab IV, Trastuzumab IV, Pertuzumab and Trastuzumab FDC SC
- Where
- 18 sites in China
- Volunteers
- 200 people
- Sponsor
- Hoffmann-La Roche
Triple-Negative Breast Cancer
A Trial Evaluating the Efficacy and Safety of EndoTAG®-1 in Combination With Paclitaxel and Gemcitabine Compared With Paclitaxel and Gemcitabine as First-line Therapy in Patients With Visceral Metastatic Triple-negative Breast Cancer
This is a prospective, multicenter, open-label, randomized, and controlled trial to test the superiority of EndoTAG®-1 in combination with paclitaxel and gemcitabine versus paclitaxel in combination with gemcitabine.
- Trial name
- NCT03002103
- Testing
- EndoTAG-1, Paclitaxel, Gemcitabine Hydrochloride
- Where
- 6 sites in Taiwan
- Volunteers
- 420 people
- Sponsor
- SynCore Biotechnology Co., Ltd.
Breast Cancer, Breast Neoplasms
Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer
This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.
- Conditions
- Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer, Stage II Breast Cancer
- Trial name
- NCT03556358
- Testing
- TX05 (trastuzumab), Herceptin®, Paclitaxel
- Where
- 146 sites in Belarus, Chile and 8 more
- Volunteers
- 809 people
- Sponsor
- Tanvex BioPharma USA, Inc.
Breast Cancer
Plant Extracted Natural Compounds Impact on Stage IV Breast Cancer Survival Time and Remission.
RATIONALE: Plant extracted natural compounds, in an adjunct therapy position, slow the growth and reproduction of Stage IV Breast Cancer tumor cells. May help eradicate different types of cancers.
- Trial name
- NCT00910884
- Testing
- laboratory biomarker analysis, therapeutic dietary intervention
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Brabant Research
HER2-positive Breast Cancer
A Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer
This trial is a registered phase III, randomized, open and multicenter study to evaluate the efficacy and safety of BL-M07D1 with or without Pertuzumab in the neoadjuvant treatment of HER2-positive breast cancer.
- Trial name
- NCT06891833
- Testing
- BL-M07D1, Pertuzumab, docetaxel
- Where
- 30 sites in China
- Volunteers
- 985 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
ER-Positive HER2-Negative Breast Cancer
A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone…
- Trial name
- SERENA-4 (NCT04711252)
- Testing
- AZD9833, Anastrozole, Palbociclib
- Where
- 263 sites in United States, Austria and 25 more
- Volunteers
- 1,371 people
- Sponsor
- AstraZeneca
Advanced Breast Cancer
A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer
This is a phase III clinical trial to evaluate the efficacy and safety of XZP-3287 in combination with Fulvestrant versus placebo combined with Fulvestrant in Patients who have HR positive and Her2 negative recurrent/metastatic…
- Trial name
- NCT05077449
- Testing
- XZP-3287+Fulvestrant
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
Breast Cancer
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal…
- Trial name
- SOLAR-1 (NCT02437318)
- Testing
- Fulvestrant, Alpelisib
- Where
- 197 sites in United States, Argentina and 29 more
- Volunteers
- 572 people
- Sponsor
- Novartis Pharmaceuticals
Neoplasms, Breast
Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2
This was a randomized, double-blind, placebo-controlled, multicenter, Phase III study to evaluate and compare the efficacy and safety of Lapatinib + Paclitaxel versus Placebo + Paclitaxel in men and women with ErbB2 amplified…
- Trial name
- NCT00281658
- Testing
- Lapatinib (GW572016) oral tablets, Paclitaxel infusion
- Where
- 54 sites in Brazil, China and 6 more
- Volunteers
- 444 people
- Sponsor
- Novartis Pharmaceuticals