Clinical trials: Early Breast Cancer (EBC)
Breast Cancer
Comparative Study of Oestradiol Suppression: Zoladex 10.8mg/3 Month vs. 3.6mg/Month in ER +ve EBC Pre-menopausal Patients
The primary purpose of this study is to establish if a 10.8 mg dose of ZOLADEX given 3 monthly is non-inferior to a 3.6 mg dose of ZOLADEX given monthly in terms of oestradiol suppression in patients with oestrogen receptor…
- Trial name
- NCT00303524
- Testing
- Goserelin acetate
- Where
- 22 sites in Japan
- Volunteers
- 170 people
- Sponsor
- AstraZeneca
Early Breast Cancer
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free…
- Trial name
- Adjuvant WIDER (NCT05827081)
- Testing
- Ribociclib, Letrozole, Ansastrozole
- Where
- 214 sites in United States, Argentina and 14 more
- Volunteers
- 1,464 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Treatment Patterns of Neratinib in HER2+ EBC in China
This is a multicenter, open-label, single-arm, non-interventional study to investigate the treatment patterns of Neratinib in HER2-positive early-stage breast cancer in China
- Trial name
- NCT05491057
- Testing
- Neratinib
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Pierre Fabre Medicament
Breast Cancer
An Observational Time and Motion Study of Trastuzumab Subcutaneous (SC) and Intravenous (IV) Formulations in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer (EBC)
This prospective, non-interventional time and motion study will evaluate the costs of healthcare resource utilization associated with the administration of trastuzumab (Herceptin) SC and IV formulations in HER2-positive EBC.
- Trial name
- NCT02658461
- Testing
- Trastuzumab
- Where
- 4 sites in United Kingdom
- Volunteers
- 36 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
In this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of…
- Trial name
- NCT00950300
- Testing
- 5-Fluorouracil, Cyclophosphamide, Docetaxel
- Where
- 106 sites in Argentina, Brazil and 24 more
- Volunteers
- 596 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study of SC Administration of Trastuzumab (Herceptin) by SID at Home in HER2-Positive EBC Participants
This single-arm, open-label, local multicenter study will evaluate the safety and tolerability of trastuzumab administered subcutaneously (SC) by a single-use injection device (SID) in participants with human epidermal growth…
- Trial name
- HOMERUS (NCT02040935)
- Testing
- Trastuzumab
- Where
- 17 sites in Netherlands
- Volunteers
- 128 people
- Sponsor
- Hoffmann-La Roche
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
Breast Cancer
10 Year Coronary Heart Disease (CHD) Risk Evaluation and Its Treatment Pattern Analysis in Postmenopausal Early Breast Cancer (EBC) Patients Taking Aromatase Inhibitors (AI)
10-year CHD risk evaluation and its treatment pattern analysis in postmenopausal early breast cancer patients taking aromatase inhibitors.
- Trial name
- NCT00885612
- Where
- 27 sites in South Korea
- Volunteers
- 1,114 people
- Sponsor
- AstraZeneca
Breast Cancer
Quality of Life in Chinese Postmenopausal HR(+) Early Breast Cancer (EBC) Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment
The purpose of the study is to evaluate quality of life (Qol) in postmenopausal HR (+) EBC patients during adjuvant AIs treatment in terms of: the change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline…
- Trial name
- BC Qol NIS (NCT01144572)
- Where
- 15 sites in China
- Volunteers
- 494 people
- Sponsor
- AstraZeneca
Breast Neoplasms
Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer.
- Trial name
- PrefHER (NCT01401166)
- Testing
- Herceptin, Single-Use Injection Device
- Where
- 75 sites in Canada, Denmark and 10 more
- Volunteers
- 488 people
- Sponsor
- Hoffmann-La Roche
Early Breast Cancer
A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)
This study involves a two-part design. Part 1 is designed to determine the optimal dose of subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in comparable exposure to intravenous (IV) Perjeta.
- Trial name
- NCT02738970
- Testing
- Trastuzumab, Pertuzumab
- Where
- 2 sites in New Zealand
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
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
A Study to Investigate the Tolerability of Subcutaneous (SC) Trastuzumab Administration in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early Breast Cancer (eBC) Using Either a Single-Use Injection Device or Manual Administration
This multicenter study in participants with HER2-positive eBC will investigate participants' pain and discomfort of SC trastuzumab (Herceptin) administered either via a single-use injection device (SID) or via vial for manual…
- Trial name
- ESCAPE (NCT02194166)
- Testing
- Trastuzumab, Paclitaxel, Docetaxel
- Where
- 7 sites in Belarus, Kazakhstan
- Volunteers
- 90 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study of Subcutaneous At Home Administration of Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2-positive (HER2+) Early Breast Cancer (eBC)
This single arm, multicenter study will evaluate the safety of assisted subcutaneous administration of trastuzumab in participants with HER2+ eBC.
- Trial name
- NCT01926886
- Testing
- Trastuzumab
- Where
- 23 sites in Belgium, Israel
- Volunteers
- 102 people
- Sponsor
- Hoffmann-La Roche