- RecruitingPHASE1, PHASE2
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
This study is testing a new medicine called EP0062 for advanced breast cancer. It aims to find the safest and most effective dose, both alone and with other standard treatments, for women whose cancer has specific features.
For: Hormone Receptor-positive Breast Cancer · Hormone Receptor Positive HER-2 Negative Breast Cancer · Metastatic Breast CancerUnited States · Spain · United Kingdom - RecruitingPHASE3
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
This study is looking at a new drug, camizestrant, for people with a common type of early breast cancer. It aims to see if camizestrant, compared to usual hormone therapy, can better prevent the cancer from coming back.
For: Breast Cancer, Early Breast CancerUnited States · Argentina · Australia - Active not recruitingPHASE2
A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment
This study looks at a new drug, PF-07220060, combined with fulvestrant for advanced or metastatic breast cancer. It compares this combination to standard treatments to see if it's safe and effective for people whose cancer has progressed after previous therapies.
For: Advanced or Metastatic Breast CancerUnited States · Argentina · Australia - RecruitingPHASE2
A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)
This study is testing a new medicine, MK-5684, for breast, ovarian, and endometrial cancers. It aims to see if MK-5684, which blocks steroid hormones, can stop cancer from growing or spreading for longer than current standard treatments.
For: Malignant NeoplasmUnited States · Argentina · Brazil - RecruitingPHASE2
A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer
This study looks for tiny traces of cancer DNA in the blood to find early signs of breast cancer coming back. If found, it tests if a new treatment combination (Palbociclib and Fulvestrant) works better than standard treatment for ER-positive, HER2-negative breast cancer.
For: ER+ Breast Cancer · HER2-negative Breast CancerFrance · United Kingdom - RecruitingPHASE2
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
This study is testing a new combination treatment for advanced breast cancer. It combines a drug called belzutifan with fulvestrant, comparing it to standard hormone therapy. The goal is to see if this new approach is effective and safe for people whose cancer has spread and is hormone-sensitive.
For: Metastatic Breast CancerUnited States · Argentina · Canada - RecruitingPHASE3
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
This study compares a new medicine called palazestrant with standard treatments for advanced breast cancer that has grown despite previous hormone therapy. It's for men and women whose cancer is ER-positive and HER2-negative.
For: Breast Cancer · Advanced Breast Cancer · Metastatic Breast CancerUnited States · Argentina · Australia - RecruitingPHASE3
Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
This study looks at new drug combinations for advanced breast cancer. It compares saruparib and camizestrant with common existing treatments to see which works best for people with specific genetic changes (BRCA1, BRCA2, or PALB2m) in their cancer.
For: Advanced Breast CancerUnited States · Argentina · Australia - RecruitingPHASE3
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
This study is for people with advanced breast cancer that has a specific genetic change (PIK3CA). It's testing a new drug, Tersolisib, alongside other cancer medicines, to see if it's safe and helps treat the disease effectively.
For: Breast Neoplasms · Neoplasm MetastasisUnited States · Argentina · Australia - Active not recruitingPHASE3
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
This study looks at a new drug, imlunestrant, for early breast cancer. It compares it to standard hormone treatments like tamoxifen, anastrozole, letrozole, and exemestane. The goal is to see if imlunestrant works better for patients whose cancer is at higher risk of returning.
For: Breast NeoplasmsUnited States · Argentina · Australia - RecruitingPHASE3
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
This study is testing a new drug, Elacestrant, against standard hormone treatments for early breast cancer. It's for men and women whose cancer is ER-positive and HER2-negative, and has a high chance of coming back. The aim is to see if Elacestrant works better.
For: Breast CancerUnited States · Argentina · Australia - Active not recruitingPHASE3
Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)
This study looks at the best treatment for women with a common type of early breast cancer. It compares hormone therapy alone against hormone therapy plus chemotherapy, using a special test to help decide which is best for each woman.
For: Breast Adenocarcinoma · Hormone Receptor Positive · Stage IA Breast Cancer AJCC v7United States · Australia · Canada - Active not recruitingPHASE3
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)
This study looks at a new drug, giredestrant, with an existing drug, everolimus, for advanced breast cancer. It compares this combination to standard hormone therapy plus everolimus, for people whose cancer has grown despite previous treatments.
For: Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast CancerUnited States · Argentina · Germany - AuthorisedTherapeutic confirmatory (Phase III)
A phase III study comparing the concurrent versus the sequential administration of chemotherapy and aromatase inhibitors, as adjuvant treatment of post-menopausal patients with endocrine-responsive early breast cancer
This study is for women who have gone through menopause and have an early type of breast cancer that responds to hormones. Researchers are looking at the best way to give two important treatments: chemotherapy and hormone therapy. They want to see if giving them at the same time or one after the other is better.
For: Breast cancer is the most common form of cancer among women in North America · Europe and Latin America. Beacause nearly 80% of breast cancers are endocrine-responsive tumors · the majority of patients candidates for adjuvant chemotherapy (CT) are also candidates for endocrine therapy (ET).The optimal timing (i.e. concomitant vs sequential administration) for the integration of these two treatments has not been clearly defined yet.Italy - AuthorisedTherapeutic exploratory (Phase II)
Individualized everolimus therapy in metastatic breast cancer
This study looks at how different ways of taking Everolimus medicine affect quality of life for people with metastatic breast cancer. It compares taking the drug once a day versus in smaller doses throughout the day.
For: metastatic breast cancerHungary - AuthorisedTherapeutic confirmatory (Phase III)
OPTIMA YOUNG : Optimal Personalized Treatment of early breast cancer using Multi-parameter Analysis : focus on YOUNGer women
This study, OPTIMA YOUNG, is for younger women with a common type of early breast cancer. It looks at the best way to treat this cancer to stop it from coming back, by comparing different medications and how well they work.
For: Premenopausal patients with high-risk HR-positive/HER2-negative breast cancer (BC) defined by tumour size and axillary lymph node status. One of the following must apply: a. 1-3 lymph nodes involved AND any invasive tumour size. b. node negative (including micrometastases in at least 1 node [i.e. deposit >0.2-2mm diameter]) AND invasive tumour size ≥ 50mm.Poland · France · Italy - AuthorisedTherapeutic confirmatory (Phase III)
J6M-MC-JSGD: A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Tersolisib (LY4064809) Combined with a CDK4/6 Inhibitor and Endocrine Therapy in Adults with HR+, HER2- Advanced Breast Cancer with a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)
This study is for adults with advanced breast cancer that is HR+, HER2-, and has a specific gene change (PIK3CA mutation), who haven't had previous treatment for advanced disease. It tests a new drug called tersolisib alongside standard hormone therapy and other targeted drugs to see if it can help stop the cancer from growing.
For: Neoplasm Metastasis · Breast NeoplasmsGermany · Greece · France - AuthorisedTherapeutic exploratory (Phase II)
NoELA_No Endocrine therapy in small HR+ HER2- low relapse risk Luminal A early breast cancer, a single-arm de-escalation trial
This study looks at whether some postmenopausal women with a specific early breast cancer might not need hormone therapy. It aims to see if they stay healthy without it, focusing on preventing the cancer from coming back and understanding side effects.
For: Postmenopausal patients with small (pT1a-b pN0) hormone receptor positive (HR⁺) and HER2 negative (HER2⁻) early breast cancer with a Luminal A phenotype and at low risk of recurrence.France - RecruitingPHASE3
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
This study is testing a new medicine, PF-07248144, with an existing one, fulvestrant, for advanced breast cancer that has grown despite previous treatment. It aims to see if this combination is safe and effective.
For: Breast CancerUnited States · Australia · Belgium - RecruitingPHASE3
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
This study is testing a new drug, camizestrant, for early breast cancer that's hormone-sensitive. We want to see if it works better than standard hormone therapy in reducing the risk of cancer coming back, for people who have already had initial treatment.
For: Breast Cancer, Early Breast CancerUnited States · Argentina · Australia