Clinical trials: Early Breast Cancer
Early-Stage Breast Cancer
Trial to Evaluate Genomic Expression Profiles to Direct Preoperative Chemotherapy in Early Stage Breast Cancer
This multi-center randomized Phase II study assigned HER2-negative early-stage breast cancer patients to receive preoperative systemic chemotherapy in either a "genomic-guided" arm or a "non-guided arm." The "genomic-guided"…
- Trial name
- NCT00636441
- Testing
- Doxorubicin/Cyclophosphamide (AC) or Docetaxel/Cyclophosphamide (TC)
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Duke University
Metastatic Breast Cancer
Corrected QT Interval Effects of Trastuzumab Emtansine (T-DM1) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer and the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients With Early Disease Progression
This is a multicenter, open-label, single-arm Phase II study designed to evaluate the effect of T-DM1 on the duration of corrected QT (QTc) interval in patients with HER2-positive locally advanced or metastatic breast cancer and…
- Trial name
- NCT00943670
- Testing
- pertuzumab, Trastuzumab emtansine [Kadcyla]
- Volunteers
- 51 people
- Sponsor
- Genentech, Inc.
Breast Cancer
Study of Stereotactic Radiotherapy for Breast Cancer
This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.
- Trial name
- NCT03043794
- Testing
- Stereotactic Body Radiation Therapy SBRT
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Breast Cancer
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer
This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).
- Trial name
- NCT01047358
- Testing
- Aromasin
- Where
- 22 sites in South Korea
- Volunteers
- 206 people
- Sponsor
- Pfizer
Breast Neoplasms
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC
- Trial name
- NCT02771795
- Testing
- Herceptin (trastuzumab), SB3 (proposed trastuzumab biosimilar)
- Where
- 40 sites in Bulgaria, Czechia and 5 more
- Volunteers
- 538 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Breast Neoplasms
Lifestyle, Exercise, and Nutrition Study Early After Diagnosis
The proposed study is a randomized trial evaluating the impact of a dietary and physical activity guidelines intervention vs. usual care on adherence to breast cancer treatments, body composition, and changes in biomarkers in 172…
- Trial name
- NCT03314688
- Testing
- Dietary/Physical Activity intervention, Usual Care
- Where
- 2 sites in United States
- Volunteers
- 173 people
- Sponsor
- Yale University
Early Stage HER2+ Breast Cancer
An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide
An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide or other prophylactic measures.
- Trial name
- NCT02400476
- Testing
- Neratinib, Loperamide, Colestipol
- Where
- 58 sites in United States, Australia and 5 more
- Volunteers
- 563 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer, Breast Neoplasms
Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer
This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.
- Conditions
- Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer, Stage II Breast Cancer
- Trial name
- NCT03556358
- Testing
- TX05 (trastuzumab), Herceptin®, Paclitaxel
- Where
- 146 sites in Belarus, Chile and 8 more
- Volunteers
- 809 people
- Sponsor
- Tanvex BioPharma USA, Inc.
Ductal Breast Carcinoma In Situ, Estrogen Receptor Negative
Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery
This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells.
- Conditions
- Ductal Breast Carcinoma In Situ, Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative
- Trial name
- NCT01754519
- Testing
- Therapeutic Conventional Surgery, Radiation Therapy, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Roswell Park Cancer Institute
Early Breast Cancer
A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)
The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014 (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus Herceptin® (Trastuzumab-EU) approved in the EU in…
- Trial name
- NCT02187744
- Testing
- PF-05280014, Taxotere®, Paraplatin®
- Where
- 52 sites in United States, Belarus and 8 more
- Volunteers
- 226 people
- Sponsor
- Pfizer
Breast Neoplasms
Effect of Trastuzumab on Disease Free Survival in Early Stage HER2-Negative Breast Cancer Patients With ERBB2 Expressing Disseminated Tumor Cells
This phase II trial studies the efficacy of trastuzumab treatment in breast cancer patients with stage II-III human epidermal growth factor receptor 2 (HER2)-negative tumors and HER2-expressing bone marrow disseminated tumor…
- Trial name
- NCT01779050
- Testing
- Doxorubicin, Trastuzumab, Cyclophosphamide
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Washington University School of Medicine
Cardiac Toxicity, Malignant Neoplasm
MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum
This trial studies how well magnetic resonance imaging (MRI) works in detecting heart damage in patients with cancer receiving chemotherapy.
- Conditions
- Cardiac Toxicity, Malignant Neoplasm, Breast Cancer
- Trial name
- NCT01719562
- Testing
- Magnetic resonance imaging, Physical Activity, Healthy Living
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- Wake Forest University Health Sciences
Breast Cancer
Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer
RATIONALE: 1. . To compare the effects on breast cancer of three different combinations of drugs which are commonly used to treat this disease. 2. . It is not yet known which treatment regimen is most effective for breast cancer.
- Trial name
- NCT00014222
- Testing
- epoetin alfa, filgrastim, cyclophosphamide
- Where
- 78 sites in United States, Canada
- Volunteers
- 2,104 people
- Sponsor
- NCIC Clinical Trials Group
Breast Cancer, Breast Cancer, Early-Onset
Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10%
This study is a window of opportunity clinical trial to evaluate the efficacy of giredestrant (GDC-9545) or tamoxifen in estrogen receptor-positive (ER[+])/human epidermal growth factor receptor 2-negative (HER2[-]) primary…
- Trial name
- EMPRESS (NCT05659563)
- Testing
- Giredestrant, Tamoxifen
- Where
- 18 sites in France, Spain
- Volunteers
- 92 people
- Sponsor
- MedSIR
Breast Neoplasms
Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer
This study investigates the feasibility and safety of delivering radiation therapy only to part of the breast, (the tumor bed and selected areas) rather than the whole breast, for patients with early stage breast cancer.
- Trial name
- NCT00325598
- Testing
- Partial Breast Irradiation (PBI)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Washington University School of Medicine
Early-Stage Breast Cancer
Proton Therapy for Early Stage Breast Cancer
The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.
- Trial name
- NCT00614172
- Testing
- Proton radiation therapy
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Loma Linda University
Breast Cancer
What Matters Most: Choosing the Right Breast Cancer Surgery for You
What Matters Most is a study that aims to determine how best to help women of lower socioeconomic status make high-quality decisions about early stage breast cancer treatments.
- Trial name
- NCT03136367
- Testing
- Option Grid, Picture Option Grid
- Where
- 5 sites in United States
- Volunteers
- 571 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Breast Cancer, Cardiac Toxicity
Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00436566
- Testing
- trastuzumab, cyclophosphamide, doxorubicin hydrochloride
- Where
- United States
- Volunteers
- 122 people
- Sponsor
- Mayo Clinic
Breast Cancer, DCIS
CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI)
This study will prospectively evaluate the technical feasibility, acute toxicity, late effects and oncologic outcomes of CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI) in early stage breast cancer.
- Conditions
- Breast Cancer, DCIS, Invasive Ductal Carcinoma
- Trial name
- CK-SAPBI (NCT02365714)
- Testing
- CK Stereotactic Accelerated Partial Breast Irradiation
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Georgetown University
Breast Cancer
A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.
This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer.
- Trial name
- NCT00545688
- Testing
- Herceptin, Docetaxel, Pertuzumab
- Where
- 77 sites in Australia, Austria and 16 more
- Volunteers
- 417 people
- Sponsor
- Hoffmann-La Roche