Clinical trials: HR+/HER2- Early Breast Cancer, open to volunteers
HR+/HER2+ Early Breast Cancer
Fovinaciclib Plus Aromatase Inhibitors and Dual HER2 Blockade in a Response-Adapted Neoadjuvant Strategy for HR-Positive/HER2-Positive Early Breast Cancer
This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant fovinaciclib in combination with aromatase inhibitors and dual HER2 blockade in patients with HR-positive/HER2-positive early…
- Trial name
- TAYLOR-003 (NCT07616427)
- Testing
- Fovinaciclib, Aromatase Inhibitors, Trastuzumab + Pertuzumab
- Where
- 3 sites in China
- Volunteers
- 100 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Breast Cancer, HR+/HER2- Early-Stage
Predicting Recurrence in HR+/HER2- Early Breast Cancer
Hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer constitutes approximately 70% of all breast cancer cases.
- Trial name
- NCT07484763
- Volunteers
- 500 people
- Sponsor
- Shengjing Hospital
Breast Cancer
Clinical Study of SHR-A1811 With or Without Letrozole in Neoadjuvant Therapy for Early-Stage HR-Positive, HER2-Low Breast Cancer
This is a prospective, randomized, multi-cohort, Phase II clinical trial. The study plans to enroll 120 patients with early-stage or locally advanced, HR-positive, HER2-low breast cancer.
- Trial name
- NCT07305246
- Testing
- SHR-A1811, Letrozole, TAC/AC-T
- Volunteers
- 120 people
- Sponsor
- First Hospital of China Medical University
HR+/HER2- Early Breast Cancer
Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative Breast Cancer
This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant culmerciclib in combination with aromatase inhibitors in patients with highly proliferative ER-positive/HER2-negative breast…
- Trial name
- TAYLOR-002 (NCT07616453)
- Testing
- Culmerciclib, Aromatase Inhibitors
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Breast Cancer, Early-Stage Breast Carcinoma
SOLIS: Single-Dose Radiotherapy With Omission of Lumpectomy for Intact Small Breast Cancers
SOLIS is a prospective, single-arm, single-institution pilot trial evaluating single-fraction stereotactic radiotherapy (24 Gy to the planning target volume with a simultaneous integrated boost of 30 Gy to the clinical target…
- Conditions
- Breast Cancer, Early-Stage Breast Carcinoma, Hormone Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
- Trial name
- SOLIS (NCT07844759)
- Testing
- Stereotactic Radiation Therapy, Endocrine Therapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Renaissance Institute of Precision Oncology and Radiosurgery
Breast Cancer Patients, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Hormonal Receptor (HR)-Positive HER2 Negative Breast Cancer Patients Treated With Preoperative ELacestrant and PULSAR Radiotherapy
This is a proof-of-concept phase II trial to assess the safety (as primary endpoint) and clinical efficacy of neoadjuvant therapy with Elacestrant and PULSAR.
- Conditions
- Breast Cancer Patients, Breast Cancer Early Stage Breast Cancer (Stage 1-3), HR+/HER2- Breast Cancer, Radiation Therapy
- Trial name
- HELP (NCT07005882)
- Testing
- Elacestrant, PULSAR
- Where
- Italy
- Volunteers
- 21 people
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
Female Breast Cancer
PROOFS-Registry - Premenopausal Women With Breast Cancer Optimally Treated With OFS
There is only limited data for premenopausal patients in general, as well as for differences in the use of OFS in the subgroups of pre- and perimenopausal patients, respectively.
- Trial name
- PROOFS (NCT05792150)
- Where
- 71 sites in Germany
- Volunteers
- 1,470 people
- Sponsor
- Women's Cancer Study Group GmbH
Breast Cancer
The Efficiency for Stage II-III HR+/HER2+ Early Breast Cancer Patient With Standard Neoadjuvant Therapy in Real World.
To observe the efficiency for patient with stage II-III HR+/HER2+ early breast cancer with standard neoadjuvant therapy, a retrospective, multicenter study in real world settings.
- Trial name
- NCT05263570
- Testing
- Standard Therapy
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shengjing Hospital
Breast Cancer
ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer
This study is a prospective, multicenter, open-label, randomized controlled clinical trial designed to determine whether ribociclib plus endocrine therapy (ET) is non-inferior to adjuvant chemotherapy followed by ribociclib plus…
- Trial name
- RACE (NCT07423611)
- Testing
- Aromatase inhibitor (± ovarian suppression) plus Ribociclib, 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy
- Where
- China
- Volunteers
- 388 people
- Sponsor
- Fudan University
Breast Cancer, Estrogen Receptor-Positive, HER2 Low Breast Cancer
A Study Evaluating the Efficacy and Safety of De Trastuzumab (T-DXd) in Combination with Immunotherapy for the Neoadjuvant Treatment of HR-positive HER2 Low-expressing Chinese Patients with Early-stage Breast Cancer
This is a prospective, open-label, multicenter, single-arm clinical study designed to compare the efficacy and safety of neoadjuvant treatment with T-DXd in combination with an immune checkpoint inhibitor in patients with primary…
- Trial name
- NCT06733233
- Testing
- T-DXd combined with immune checkpoint inhibitor
- Volunteers
- 23 people
- Sponsor
- Guangzhou Women and Children's Medical Center
Early Breast Cancer, Premenopausal Breast Cancer
Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests
Rationale: Around 70 to 80% of breast cancers are so-called "hormone-dependent" (HR+)/HER2-. For more than 50 years, studies have shown that chemotherapy and optimised hormonal treatments (hormone therapy), including a drug…
- Conditions
- Early Breast Cancer, Premenopausal Breast Cancer, HR+/HER2- Breast Cancer
- Trial name
- OPTIMA-YOUNG (NCT07106632)
- Testing
- test-directed treatment: allocated treatment will depend on the PAM50 score result (centrally assessed) : chemo-endocrine therapy or endocrine therapy alone, In the control arm, the treatment will be as standard of care : chemo-endocrine therapy
- Where
- 105 sites in Belgium, France and 5 more
- Volunteers
- 3,380 people
- Sponsor
- UNICANCER
Breast Cancer (Early Breast Cancer)
Skipping Hormone Therapy in Low-Risk Early Breast Cancer
The goal of this clinical trial is to determine whether a selected population of women with early-stage, low-risk breast cancer can avoid hormone therapy without increasing their risk of relapse.
- Trial name
- NoELA (NCT07661927)
- Testing
- Removing Endocrine Therapy
- Where
- 41 sites in France
- Volunteers
- 700 people
- Sponsor
- UNICANCER
Breast Cancer
CDK4/6 Inhibitor Intensification and Chemotherapy De-Escalation for Early-stage Luminal-HER2 Breast Cancer
The investigators designed a phase III clinical trial involving hormone receptor-positive and HER2-positive stage I breast cancer patients.
- Trial name
- Cinderella (NCT07213206)
- Testing
- CDK 4/6 inhibitor combined therapy (omit chemo), standard of care
- Volunteers
- 1,500 people
- Sponsor
- Fudan University
HR+/HER2- Early Breast Cancer
RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia
This is a non-interventional, prospective, single-arm, observational study describing the real-world effectiveness, safety, and PRO and HCRU data of ribociclib combined with adjuvant ET under conditions of routine clinical…
- Trial name
- NISLEESA (NCT06797531)
- Testing
- ribociclib
- Where
- 2 sites in Saudi Arabia
- Volunteers
- 177 people
- Sponsor
- Novartis Pharmaceuticals
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
Early-stage Breast Cancer, Hormone Receptor Positive Breast Carcinoma
Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer
This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer.
- Conditions
- Early-stage Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Invasive Breast Cancer, Stage II Breast Cancer
- Trial name
- NCT04553770
- Testing
- Anastrozole, Therapeutic Conventional Surgery, Trastuzumab Deruxtecan
- Where
- 9 sites in United States
- Volunteers
- 88 people
- Sponsor
- Jonsson Comprehensive Cancer Center
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 Diseases, Breast Neoplasms
Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study
This study is a multicenter, prospective, randomized, open-label clinical study to assess the efficacy and safety of endocrine combined with different doses and treatment duration of darisenatide adjuvant therapy in HR +/HER2…
- Conditions
- Breast Diseases, Breast Neoplasms, Dalpiciclib, Endocrine Breast Diseases
- Trial name
- NCT07581834
- Testing
- Dalpiciclib 125mg, Dalpiciclib 100mg, Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen
- Where
- 2 sites in China
- Volunteers
- 2,000 people
- Sponsor
- Fujian Cancer Hospital
Omitting Sentinel Lymph Node Biopsy in Early-stage Breast Cancer
De-escalation in Axillary Surgery for Early-stage Breast Cancer
The goal of this clinical trial is to determine if the omission of sentinel lymph node biopsy is safe for early-stage breast cancer patients in our institution (Clinical Hospital Centre Rijeka).
- Trial name
- RIDES (NCT07098507)
- Testing
- sentinel lymph node biopsy, omission of sentinel lymph node biopsy
- Where
- Croatia
- Volunteers
- 620 people
- Sponsor
- Clinical Hospital Center Rijeka
Breast Cancer
Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer
Brief Summary This is an open-label, randomized, phase II clinical study designed to evaluate neoadjuvant treatment regimens in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative…
- Trial name
- NCT07492394
- Testing
- entinostat, Dalpiciclib, Letrozole
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Hebei Medical University Fourth Hospital