Clinical trials: Premenopausal Breast Cancer
Breast Cancer
An Indirect Treatment Comparison of the Effectiveness of Ribociclib Combined With Non-steroidal Aromatase Inhibitors vs. Tamoxifen for the Adjuvant Treatment of Premenopausal Women With Hormon Receptor-positive, HER2-negative Early Breast Cancer
The purpose of this indirect treatment comparison (ITC) was to generate comparative evidence on the effectiveness and safety in premenopausal women of ribociclib+Non-steroidal Aromatase Inhibitor (NSAI)+Ovarian Function…
- Trial name
- IRINA (NCT07072013)
- Testing
- ribociclib
- Where
- Germany
- Volunteers
- 1,937 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
TOL2506A (OVELIA) is a Phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 in suppressing ovarian function in premenopausal women with HR+, HER2-negative breast cancer and men with HR+ breast cancer.
- Trial name
- NCT05645536
- Testing
- TOL2506, Tamoxifen, Letrozole tablets
- Where
- 46 sites in United States, Argentina and 4 more
- Volunteers
- 250 people
- Sponsor
- Tolmar Inc.
Advanced Breast Cancer, Early Breast Cancer
A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast Cancer
The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH) within each cohort.
- Trial name
- NCT07310420
- Testing
- ZOLADEX
- Where
- 26 sites in United States
- Volunteers
- 176 people
- Sponsor
- TerSera Therapeutics LLC
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
Study on Pre-menopausal Patients With Advanced ER and PR + BC Treated With Arimidex Plus Zoladex
The purpose of this study is to determine the efficacy and tolerance of the association of two drugs already marketed and used to treat your disease: Arimidex® 1 Mg per day per os and Zoladex® 3,6 Mg in injections under cutaneous…
- Trial name
- NCT00235937
- Testing
- Anastrozole and goserelin
- Where
- 7 sites in France
- Volunteers
- 45 people
- Sponsor
- AstraZeneca
Breast Cancer
Zoladex® 10.8 BC RWS
This is a multi-center, retrospective-prospective, observational, active-control, non-inferiority, real world study using hospital medical record data, with objectives to evaluate E2 suppressive effect of Zoladex® 10.8 mg is…
- Trial name
- NCT05184257
- Where
- 16 sites in China
- Volunteers
- 1,176 people
- Sponsor
- AstraZeneca
Breast Cancer
The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss
This study examines the safety and efficacy of zoledronic acid 4 mg., given every 3 months over 24 months (infusion at month 0, 3, 6, 9, 12, 15, 18 and 21) in improving bone mineral density in premenopausal women with hormone…
- Trial name
- NCT00375505
- Testing
- Zoledronic acid
- Where
- Germany
- Volunteers
- 70 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer Subjects
Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
The study is to assess the safety, efficacy and pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
- Trial name
- NCT06449027
- Testing
- T Leuprolide Injectable Emulsion, Leuprorelin Acetate Microspheres for Injection
- Where
- China
- Volunteers
- 211 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Breast Cancer, Ovarian Function
Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy
Primary objective of this study is to determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing adjuvant chemotherapy for primary invasive breast cancer by…
- Trial name
- PROOF (NCT00888082)
- Testing
- Goserelin acetate
- Where
- 3 sites in Turkey (Türkiye)
- Volunteers
- 102 people
- Sponsor
- AstraZeneca
Breast Cancer
Pharmacodynamic Study Goserelin 3.6mg Injection Administered Subcutaneously in Premenopausal Patients with Breast Cancer
A two arm, multi centric, randomized, open label, parallel, multiple dose pharmacodynamic study in premenopausal patients with advanced breast cancer.
- Trial name
- NCT03936933
- Testing
- Goserelin acetate 3.6 mg Injection, ZOLADEX® 3.6mg Injection
- Where
- India
- Volunteers
- 6 people
- Sponsor
- Eurofarma Laboratorios S.A.
HER2-positive, Adenocarcinoma
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.
- Conditions
- HER2-positive, Adenocarcinoma, Bile Duct Cancer, Biliary Tract Cancer
- Trial name
- NCT04660929
- Testing
- CT-0508, Pembrolizumab
- Where
- 7 sites in United States
- Volunteers
- 48 people
- Sponsor
- Carisma Therapeutics Inc
Breast Cancer
Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey: "QOL Survey in Premenopausal Breast Cancer Patients"
The purpose of this survey is to examine the effect on quality of life (QOL) improvement and convenience of switching to leuprorelin acetate 3 months depot 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit)…
- Trial name
- NCT02134977
- Testing
- Leuprorelin Acetate
- Volunteers
- 2,816 people
- Sponsor
- Takeda
Breast Neoplasms, Invasive Breast Cancer
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer.
- Conditions
- Breast Neoplasms, Invasive Breast Cancer, Estrogen-receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- EVANGELINE (NCT05607004)
- Testing
- (Z)-endoxifen, goserelin
- Where
- 14 sites in United States
- Volunteers
- 87 people
- Sponsor
- Atossa Therapeutics, Inc.
Premenopausal Breast Cancer
A Phase 3 Comparative Study of TAP-144-SR(6M) in Postoperative and Hormone Therapy-naïve Patients With Premenopausal Breast Cancer
Hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) will be evaluated against TAP-144-SR(3M) in postoperative and hormone therapy-naïve patients with premenopausal breast cancer
- Trial name
- NCT01546649
- Testing
- TAP-144-SR(6M), TAP-144-SR(3M)
- Where
- 15 sites in Japan
- Volunteers
- 167 people
- Sponsor
- Takeda
Premenopausal Breast Cancer
Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.
- Trial name
- NCT03209518
- Testing
- Leuprorelin acetate
- Where
- Japan
- Volunteers
- 312 people
- Sponsor
- Takeda
Breast Cancer
Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment
The purpose of this multi-centre, randomised, double-blind, parallel-group study is to compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative administration under goserelin acetate treatment for…
- Trial name
- NCT00605267
- Testing
- Tamoxifen, Anastrazole (Arimidex), Goserelin acetate (Zoladex)
- Where
- 4 sites in Japan
- Volunteers
- 197 people
- Sponsor
- AstraZeneca
Pre-menopausal Breast Cancer, PI3K Pathway Inhibition
A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer
Based on the evidence acquired in the post-menopausal setting with everolimus and on pre-clinical evidences supporting the investigation of PI3K inhibitors, such as alpelisib and buparlisib, in combination with endocrine therapy…
- Trial name
- B-YOND (NCT02058381)
- Testing
- alpelisib (BYL719), buparlisib (BKM120)
- Where
- 15 sites in Hong Kong, South Korea and 2 more
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib
This study was a companion study to CLEE011A2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.
- Trial name
- NCT03050398
- Testing
- Ribociclib, letrozole
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
This is a phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 to suppress ovarian function in premenopausal women with HR+, HER2-negative breast cancer.
- Trial name
- OVELIA (NCT04906395)
- Testing
- TOL2506, Tamoxifen, Letrozole Tablets
- Where
- 59 sites in United States, Argentina and 5 more
- Volunteers
- 250 people
- Sponsor
- Tolmar Inc.
Advanced Metastatic Breast Cancer
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a…
- Trial name
- MONALEESA-7 (NCT02278120)
- Testing
- Ribociclib, Tamoxifen, Letrozole
- Where
- 183 sites in United States, Argentina and 28 more
- Volunteers
- 672 people
- Sponsor
- Novartis Pharmaceuticals