Clinical trials: Hormone Receptor Positive Early Breast Cancer
Breast Cancer
Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy
Patients with estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) breast cancer do not achieve good responses with pre-operative chemotherapy.
- Trial name
- NCT05069038
- Testing
- Palbociclib 125mg
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- University of Nebraska
Early Breast Cancer
A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal…
- Trial name
- NATALEE (NCT03701334)
- Testing
- Ribociclib, Endocrine Therapy (ET)
- Where
- 387 sites in United States, Argentina and 18 more
- Volunteers
- 5,101 people
- Sponsor
- Novartis Pharmaceuticals
Hormone Receptor-Positive, HER2-Negative, Node Positive Breast Cancer
Neoadjuvant Letrozole in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative, Node Positive, Early-Stage Breast Cancer.
The goal of this clinical trial is to learn whether letrozole, a hormone therapy drug, is effective in treating early-stage, hormone receptor-positive, HER2-negative breast cancer that has spread to nearby lymph nodes in…
- Trial name
- NELOPHER (NCT07394946)
- Testing
- Letrozole
- Where
- Pakistan
- Volunteers
- 126 people
- Sponsor
- Cancer Care Hospital & Research Centre Foundation, Lahore
Breast Neoplasms, Breast Cancer
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early…
- Conditions
- Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma
- Trial name
- I-SPY (NCT01042379)
- Testing
- Standard Therapy, AMG 386 with or without Trastuzumab, AMG 479 (Ganitumab) plus Metformin
- Where
- 42 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- QuantumLeap Healthcare Collaborative
Breast Cancer, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
A Study to Determine the Efficacy of a Digital Self-management Support Tool to Improve the Quality of Life During Adjuvant HOrmonal Therapy for Patients With Early Breast Cancer
Randomized trial that compares a personalized digitally-enabled pathway delivered by a mobile application in addition to standard of care vs.
- Trial name
- HOPE (NCT06781996)
- Testing
- multimodal Resilience© digital companion, Standard supportive care
- Where
- France
- Volunteers
- 180 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
HR+/HER2- Early Breast Cancer
IMPLEMENTING PATIENTS' COMPETENCE IN ORAL EBC THERAPY PERSISTENCE
The goal of this interventional study is to evaluate the effect of standardized patient coaching on treatment adherence among patients taking abemaciclib.
- Trial name
- IMPACT PT (NCT07521202)
- Testing
- Standardized patient coaching
- Where
- Germany
- Volunteers
- 257 people
- Sponsor
- Institut fuer Frauengesundheit
Breast Neoplasms, Carcinoma, Ductal, Breast
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Receptors, Estrogen (for ER-positive Requirement)
- Trial name
- SIGNAL-ER 101 (NCT07214532)
- Testing
- ctDNA-Guided Treatment Strategy
- Where
- 49 sites in United States
- Volunteers
- 725 people
- Sponsor
- Natera, Inc.
Breast Cancer
Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer
This is an international, multi-center, randomized, double-blinded, placebo-controlled clinical study evaluating the efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone…
- Trial name
- EarLEE-2 (NCT03081234)
- Testing
- Ribociclib, Adjuvant endocrine therapy
- Sponsor
- Novartis Pharmaceuticals
Invasive Early Breast Cancer
A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer
The IES study (A5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen, who either continued the same treatment or switched to Aromasin® for a total treatment period of 5 years.
- Trial name
- NCT01121549
- Testing
- Aromasin
- Where
- 40 sites in Romania
- Volunteers
- 378 people
- Sponsor
- Pfizer
Breast Cancer
Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients
Primary objective: Determine the impact of the Oncotype DX Recurrence Score (RS) on the treatment recommendation made (administration of chemotherapy or not, in addition to hormonotherapy) in a HR+, N- or pN1(mi), Her2- breast…
- Trial name
- SWITCH (NCT01446185)
- Testing
- Oncotype DX breast cancer test
- Where
- 6 sites in France
- Volunteers
- 100 people
- Sponsor
- Genomic Health®, Inc.
Breast Cancer
Ax-003/Arimidex (Anastrozole) in the Adjuvant Therapy of Early Breast Cancer
The purpose of this study is the initial/followed by 5 year adjuvant therapy with Anastrozole.
- Trial name
- Ax-003 (NCT00638391)
- Testing
- Anastrozole
- Volunteers
- 1,600 people
- Sponsor
- AstraZeneca
Early Breast Cancer, Adjuvant Therapy
Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients
This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast…
- Conditions
- Early Breast Cancer, Adjuvant Therapy, Hormone Receptor Positive / HER2-negative Breast Cancer
- Trial name
- NCT07101159
- Testing
- Dalpiciclib, Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
- Volunteers
- 200 people
- Sponsor
- Fujian Cancer Hospital
Breast Cancer
Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer
This was an open label, multi-center protocol for U.S. patients enrolled in the study of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk early breast…
- Trial name
- EarLEE-1 (NCT03078751)
- Testing
- Ribociclib, Adjuvant endocrine therapy
- Where
- 33 sites in United States
- Volunteers
- 54 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Hormone Receptor Positive Tumor
A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer
The purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with…
- Conditions
- Breast Cancer, Hormone Receptor Positive Tumor, Early-Stage Breast Carcinoma
- Trial name
- neoMONARCH (NCT02441946)
- Testing
- Abemaciclib, Loperamide, Anastrozole
- Where
- 66 sites in United States, Austria and 8 more
- Volunteers
- 224 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Effects of Physical Activity in Early Stage Hormone Receptor Positive Breast Cancer Patients
The advances in early detection coupled with improvements in treatments have led to an ever-increasing number of breast cancer survivors.
- Trial name
- NCT07539038
- Where
- Italy
- Volunteers
- 44 people
- Sponsor
- Centro di Riferimento Oncologico - Aviano
Breast Cancer
Fulvestrant (Faslodex) + Anastrozole (Arimidex) vs Anastrozole
Postmenopausal women with hormone receptor positive and negative Her2 tumours. Before randomization, the patients will be stratified according to the center, positive nodes (0 vs. 1-3 vs.
- Trial name
- NCT00543127
- Testing
- Fulvestrant, Anastrozole
- Where
- 53 sites in Spain
- Volunteers
- 870 people
- Sponsor
- Spanish Breast Cancer Research Group
Breast Cancer, Breast Neoplasms
Tirzepatide Weight Loss for MRD+ Early Breast Cancer
This trial aims to asses if tirzepatide-induced weight loss will lead to metabolic and hormonal changes in hormone receptor-positive (HR+), human epidermal growth factor receptor-negative (HER2-), node-positive (N+) high risk…
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancers
- Trial name
- TRIM-EBC (NCT06517212)
- Testing
- Tirzepatide
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Baylor Research Institute
Early-stage Breast Cancer, HER2-positive Breast Cancer
Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab
Neratinib is an irreversible pan-HER tyrosine kinase inhibitor (TKI). Currently, no studies have investigated the use of macromolecular anti-HER2 agents combined with TKIs for the treatment of non-pCR HER2-positive breast cancer…
- Conditions
- Early-stage Breast Cancer, HER2-positive Breast Cancer, Adjuvant Treatment After Trastuzumab, RCB Classification 1-2
- Trial name
- NCT05760612
- Testing
- Trastuzumab and neratinib, Trastuzumab and Pertuzumab
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer, Adjuvant Treatment
Impact of Oncotype DX® on Treatment Recommendation and Its Economic Evaluation Under the Brazilian Society Perspective
155 Pérola Byington Hospital patients presenting early stage luminal BC were submitted to Oncotype Dx® evaluation. Changes in treatment recommendations and costs were obtained from Pérola Byington Hospital.
- Trial name
- NCT05100277
- Testing
- Oncotype DX® Assay, Cost
- Where
- Brazil
- Volunteers
- 155 people
- Sponsor
- Hospital Perola Byington
Early Breast Cancer
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive…
- Trial name
- NCT06341894
- Testing
- Dalpiciclib, Endocrine therapy
- Where
- China
- Volunteers
- 1,163 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University