Clinical trials: Early Breast Cancer
Breast Cancer
Breast VCEUS to Evaluate Early Response to Neoadjuvant Chemotherapy
1. Evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy and compare results to co-temporal volume change on grayscale ultrasound and post-treatment mammography findings…
- Trial name
- NCT01817374
- Testing
- 2D US grayscale plus quantitative VCEUS
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Alabama at Birmingham
Breast Cancer
Low-dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor-negative Early Breast Cancer
This randomized, phase III trial was designed to test the efficacy of a low-dose chemotherapy-maintenance regimen, hypothesized to have anti-angiogenic activity, administered following standard chemotherapy in patients with early…
- Trial name
- 22-00 (NCT00022516)
- Testing
- Cyclophosphamide, Methotrexate
- Where
- 36 sites in Australia, Belgium and 9 more
- Volunteers
- 1,086 people
- Sponsor
- ETOP IBCSG Partners Foundation
Breast Cancer
MRI in Evaluating Early Response to Chemotherapy in Women With Infiltrating Breast Cancer
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in learning how well chemotherapy works to kill breast cancer cells and allow doctors to plan better treatment.
- Trial name
- ISNA-Sein (NCT00462696)
- Testing
- Neoadjuvant chemotherapy
- Where
- France
- Volunteers
- 16 people
- Sponsor
- Institut Bergonié
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, Adjuvant Therapy
A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib
The purpose of this study is to describe the demographic and clinical profiles of patients with early-stage HER2+ breast cancer treated with neratinib as an extended adjuvant therapy as part of the Early Access Program (EAP) in…
- Conditions
- Breast Cancer, Adjuvant Therapy, HER2-positive Breast Cancer
- Trial name
- NEAR (NCT05599334)
- Where
- 25 sites in Belgium, Croatia and 3 more
- Volunteers
- 111 people
- Sponsor
- Pierre Fabre Medicament
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
A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer
This study is looking at whether Metformin, an agent that is commonly used to treat diabetes, can decrease or affect the ability of breast cancer cells to grow and whether Metformin will work with other therapies to keep cancer…
- Trial name
- NCT01101438
- Testing
- metformin hydrochloride
- Where
- 344 sites in United States, Canada and 2 more
- Volunteers
- 3,649 people
- Sponsor
- Canadian Cancer Trials Group
Early Stage Breast Cancer
Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer
The purpose of this study is to see whether taking denosumab for 12 months in women with a significant number of disseminated tumor cells in the bone marrow can reduce the number of these cells below a significant level.
- Trial name
- NCT01545648
- Testing
- Denosumab
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Hope Rugo, MD
Invasive Breast Carcinoma, Stage I Breast Cancer AJCC v7
The Effect of Simvastatin on Breast Cancer Cell Growth in Women With Stage I-II Breast Cancer
The purpose of this pilot phase II trial is to identify the molecular and genetic mechanisms by which statins influence breast cancer cell proliferation.
- Conditions
- Invasive Breast Carcinoma, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7
- Trial name
- NCT03454529
- Testing
- Laboratory Biomarker Analysis, Simvastatin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Michael Simon
Breast Cancer
Trial of Chemotherapy and Avastin as Treatment for Women With Breast Cancer at High Risk for Relapse
Women with breast cancer who are not eligible for breast conserving surgery or who have node-involvement are sometimes treated with chemotherapy up front, in hopes of allowing for a woman to keep her breast and decreasing the…
- Trial name
- NCT00462865
- Testing
- Gemcitabine and Capecitabine and Avastin
- Where
- 3 sites in United States
- Volunteers
- 18 people
- Sponsor
- Brown University
Ductal Breast Carcinoma in Situ, Invasive Ductal Breast Carcinoma
Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy
This pilot clinical trial studies caloric restriction in patients with stage 0-I breast cancer during surgery and radiation therapy. Reducing caloric intake may prevent disease progression in patients with breast cancer.
- Conditions
- Ductal Breast Carcinoma in Situ, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma, Lobular Breast Carcinoma in Situ
- Trial name
- CAREFOR (NCT01819233)
- Testing
- Behavioral dietary intervention, Therapeutic conventional surgery, Radiation therapy
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Breast Cancer, Hormone Changes
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect normal ovarian cells from the side effects of…
- Conditions
- Breast Cancer, Hormone Changes, Drug Toxicity
- Trial name
- NCT00090844
- Testing
- triptorelin
- Where
- 9 sites in United States
- Volunteers
- 49 people
- Sponsor
- University of South Florida
Breast Cancer
Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2
The goal of this clinical research study is to learn if and how well eribulin, given in combination with standard chemotherapy, can treat early-stage breast cancer compared to paclitaxel given in combination with standard…
- Trial name
- NCT01593020
- Testing
- Paclitaxel, Eribulin, 5-Fluorouracil
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- M.D. Anderson Cancer Center
Ductal Breast Cancer
Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer
The purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer.
- Trial name
- NCT00694577
- Testing
- Partial Breast Irradiation using 32 Gy / 8 fractions, Partial Breast Irradiation using 36 Gy / 9 fractions, Partial Breast Irradiation using 40 Gy /10 fractions
- Where
- 4 sites in United States
- Volunteers
- 324 people
- Sponsor
- Massachusetts General Hospital
Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma
Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer
This phase II trial studies how well hypofractionated radiation therapy works in treating patients with stage 0-IIB breast cancer.
- Conditions
- Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma, Stage 0 Breast Cancer, Stage I Breast Cancer
- Trial name
- NOVEMBER (NCT03345420)
- Testing
- Hypofractionated Radiation Therapy
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- University of Utah
HER2 Positive Early or Locally Advanced Breast Cancer
A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer
A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab biosimilar) and Herceptin® in Women with Newly…
- Trial name
- NCT02149524
- Testing
- Herceptin (trastuzuamb), SB3 (proposed trastuzumab biosimilar)
- Where
- Czechia
- Volunteers
- 875 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Breast Cancer
Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer
The purpose of this study is to determine if ribociclib in combination with letrozole for 24 weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative Endocrine Prognostic Index (PEPI) score of 0…
- Trial name
- FELINE (NCT02712723)
- Testing
- Letrozole, Ribociclib
- Where
- 13 sites in United States
- Volunteers
- 121 people
- Sponsor
- Qamar Khan
Breast Cancer
Evaluating Whether Integration of Prognostic and Predictive Algorithms Into Routine Clinical Practice Effect Whether Oncologists Order Multigene Assays in Patients With Early Stage Breast Cancer
A broad range of prognostic and predictive tools are available for patients with newly diagnosed early stage breast cancer. These range from free and publicly available mathematical algorithms, through to expensive genomic tests.
- Trial name
- REaCT-Algorith (NCT04131933)
- Where
- 6 sites in Canada
- Volunteers
- 602 people
- Sponsor
- Ottawa Hospital Research Institute
Breast Cancer, Overweight or Obesity
Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study
This is a single arm phase II study designed to determine the effects of pharmacotherapy and a remote behavioral weight loss intervention on weight loss in breast cancer survivors who are overweight or obese, and the impact of…
- Trial name
- A-NEW (NCT04499950)
- Testing
- Contrave, Behavioral Weight Loss
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins