Clinical trials: HR+ HER2- Breast Cancer
Breast Cancer, Chemotherapeutic Toxicity
AC vs TC in Patients With HR-positive, HER2-negative Early Breast Cancer
Anthracycline-paclitaxel sequential combination therapy is the standard regimen for perioperative chemotherapy in breast cancer. The strategy of perioperative chemotherapy is based on breast cancer subtype, i.e.
- Trial name
- NCT05302336
- Testing
- Liposomal doxorubicin + Cyclophosphamide vs Docetaxel + Cyclophosphamide
- Where
- China
- Volunteers
- 402 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Metastatic Breast Cancer
Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer
Neutropenia is a common complication from dalpiciclib. Mecapegfilgramtim (code name HHPG-19K), a long-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF), has been developed.
- Trial name
- NCT05463601
- Testing
- Mecapegfilgrastim, dalpiciclib, exemestane, fulvestrant, letrozole, tamoxifen
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Neoplasm, Neoplasm Metastasis
Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred…
- Trial name
- postMONARCH (NCT05169567)
- Testing
- Abemaciclib, Fulvestrant
- Where
- 138 sites in United States, Argentina and 15 more
- Volunteers
- 368 people
- Sponsor
- Eli Lilly and Company
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
Breast Cancer, CDK4/6 Inhibitor
Development of a New Remote Monitoring Model for Patients With HR+HER2- Breast Cancer in Treatment With CDK4/6 Inhibitors and Hormone Therapy
This study aims to develop and prospectively validate a questionnaire to select patients with breast cancer who need to access to hospital for clinical visit during treatment with CDK4/6i, to improve patients' quality of life and…
- Trial name
- VIRTUOSA (NCT07190651)
- Testing
- Home questionnaire
- Volunteers
- 50 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
HR Positive HER2 Negative Advanced Breast Cancer
Iribrine Plus Tucidinostat in the Treatment of HR+/HER2 Advanced Breast Cancer After CDK4/6 Inhibitor Failure
To explore the safety and efficacy of Eribulin plus Tucidinostat amine in patients with HR+/ HER2-advanced metastatic breast cancer
- Trial name
- NCT05335473
- Testing
- Eribulin and Tucidinostat
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Henan Cancer Hospital
HR+/HER2- Breast Cancer
BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease
The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole…
- Trial name
- KANDELA-302 (NCT07492641)
- Testing
- BGB-43395, Letrozole, Abemaciclib
- Where
- 241 sites in United States, Australia and 14 more
- Volunteers
- 1,056 people
- Sponsor
- BeOne Medicines
Metastatic HR+/HER2- Breast Cancer
Rash & Diarrhea Prophylaxis With Capivasertib
This is a randomized, multicenter, phase II clinical trial evaluating prophylactic strategies to mitigate common toxicities associated with capivasertib in combination with fulvestrant in participants with hormone…
- Trial name
- SAFE-CAP (NCT07426822)
- Testing
- Capivasertib, Loperamide, Fulvestrant
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Maryam Lustberg
Advanced HR-positive and HER2-negative Breast Cancer; CDK4/6 Inhibitor Treatment Failed
Dalpiciclib Combination With Fulvestrant and Compound Gossyfol Acetate Tablets in Women With CDK4/6 Inhibitor-refractory HR-positive HER-2 Negtive Metastatic Breast Cancer: a Phase 2 Clinical Trial.
This is a single-arm, Phase II clinical study to explore the efficacy and safety of dalpiciclib combined with fluvestrant and compound gossypol acetate tablets in advanced HR-positive and HER2-negative breast cancer after CDK4/6…
- Trial name
- NCT06133088
- Testing
- dalpiciclib; fluvestrant; compound gossypol acetate tablets
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Zhejiang Cancer Hospital
Breast Cancer, Invasive Breast Cancer
Window of Opportunity Trial of Entinostat in Patients With Newly Diagnosed Stage I-IIIC,TNBC
This study is investigational and is not designed to treat cancer. In other words, the study drug, entinostat, is not being given to treat cancer.
- Conditions
- Breast Cancer, Invasive Breast Cancer, ER-Negative PR-Negative HER2-Negative Breast Cancer
- Trial name
- NCT03361800
- Testing
- Entinostat
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1…
- Conditions
- HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors, HR+ HER2- Breast Cancer
- Trial name
- NCT07029399
- Testing
- NKT5097 CDK2/CDK4 dual degrader, Fulvestrant, Letrozole
- Where
- 19 sites in United States
- Volunteers
- 361 people
- Sponsor
- NiKang Therapeutics, Inc.
Breast Cancer, Early Stage
Ablation Compare With Surgery for Early Breast Cancer
Breast-conserving surgery has been widely used in clinical practice, but surgical incisions still impact postoperative patient satisfaction with breast appearance.
- Conditions
- Breast Cancer, Early Stage, Hormone Receptor Positive, Ablation
- Trial name
- NCT07484087
- Testing
- breast conserving surgery, cryo-thermal ablation
- Where
- China
- Volunteers
- 264 people
- Sponsor
- Peking University People's Hospital
HR+/HER2- Breast Cancer, Breast Neoplasms
Kumorixilib Plus Capecitabine and Letrozole for Neoadjuvant Treatment of HR-Positive HER2-Negative Breast Cancer
This study is a single-center, prospective, open-label exploratory clinical study to assess the efficacy and safety of kumorixilib combined with capecitabine and letrozole as neoadjuvant therapy in patients with HR+/HER2- stage…
- Trial name
- NCT07691333
- Testing
- Kumorixilib 180mg, Capecitabine 500mg, Letrozole 2.5mg
- Where
- 3 sites in China
- Volunteers
- 35 people
- Sponsor
- Fujian Cancer Hospital
Breast Cancer
A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Combination of Trastuzumab and Pertuzumab With or Without Concurrent Taxane Chemotherapy Given for Twelve Weeks in Patients With Operable HER2+/HR- Breast Cancer Within the ADAPT Protocol
Trial to evaluate efficacy of dual blockade with two anti-HER2 agents with or without chemotherapy backbone within the ADAPT trial.
- Trial name
- ADAPT (NCT01817452)
- Testing
- Trastuzumab, Pertuzumab, Paclitaxel
- Where
- Germany
- Volunteers
- 220 people
- Sponsor
- Women's Cancer Study Group GmbH
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Hormone Receptor (HR)-Positive Breast Cancer
Palbociclib With Everolimus + Exemestane In BC
This research study is studying a combination of targeted therapy and hormonal therapy as a possible treatment for breast cancer that has spread to other places in the body and is hormone receptor positive (HR+) and…
- Trial name
- NCT02871791
- Testing
- Palbociclib, Everolimus, Exemestane
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Dana-Farber Cancer Institute
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation…
- Trial name
- NCT04967248
- Testing
- Alpelisib, Fulvestrant
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer Female
Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC
The study investigates, whether the patient group with intermediate-risk early breast cancer benefits from treatment with ribociclib in combination with endocrine therapy compared to standard-of-care chemotherapy (followed by…
- Trial name
- ADAPTcycle (NCT04055493)
- Testing
- Ribociclib 200Mg Oral Tablet
- Where
- 86 sites in Germany
- Volunteers
- 1,684 people
- Sponsor
- Women's Cancer Study Group GmbH
Breast Cancer
RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based…
- Trial name
- NCT04460898
- Where
- United States
- Volunteers
- 195 people
- Sponsor
- Pfizer
Breast Cancer
Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole
This is a retrospective, multicenter, observational study in Japan. The primary objective is to evaluate overall survival (OS) in Japanese patients with HR+/HER2- advanced breast cancer who have been treated with palbociclib plus…
- Trial name
- NCT04735367
- Testing
- palbociclib plus letrozole
- Where
- 13 sites in Japan
- Volunteers
- 42 people
- Sponsor
- Pfizer
Advanced Breast Cancer
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
- Trial name
- MONALEESA-3 (NCT02422615)
- Testing
- Ribociclib, Fulvestrant
- Where
- 174 sites in United States, Australia and 28 more
- Volunteers
- 726 people
- Sponsor
- Novartis Pharmaceuticals