An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer
NCT02286362 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 510
Last updated 2017-09-27
Summary
This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice. Patients with HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with Herceptin SC in routine clinical practice use are eligible to participate. The total study duration is anticipated to be 38 months.
Conditions
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-01-14
- Primary Completion
- 2016-11-10
- Completion
- 2016-11-10
Countries
- France
Study Locations
More Related Trials
-
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)
NCT01926886 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Cardiac Safety in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin
NCT01152606 ·Status: COMPLETED
-
A Study of the Safety of Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Early and Locally Advanced Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
NCT01940497 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX
NCT06723990 ·Status: RECRUITING
-
Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer
NCT00045032 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.
NCT00545688 ·Status: COMPLETED ·Phase: PHASE2
-
H.E.R.O.S. Study: An Observational Study of the Cardiac Safety of Herceptin (Trastuzumab) in Patients With HER2-Positive Breast Cancer
NCT01991340 ·Status: COMPLETED
-
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
NCT02194166 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer
NCT02443467 ·Status: COMPLETED
-
Preoperative Herceptin and Navelbine for Breast Cancer
NCT00148681 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Participant Satisfaction and Safety With Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer
NCT01964391 ·Status: COMPLETED ·Phase: PHASE3
-
Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
NCT00270894 ·Status: COMPLETED ·Phase: PHASE2
-
Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
NCT01401166 ·Status: COMPLETED ·Phase: PHASE2
-
A Dose-Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Females
NCT00800436 ·Status: COMPLETED ·Phase: PHASE1
-
Recurrence Score-guiding Chemotherapy in Non-pCR HR Positive HER2 Negative Breast Cancer After Neoadjuvant Therapy
NCT03638648 ·Status: UNKNOWN ·Phase: PHASE2
-
Efficacy of Neoadjuvant Subcutaneous Trastuzumab-Pertuzumab in Algerian Women With Locally Advanced HER2 Positive Breast Cancer
NCT07166185 ·Status: RECRUITING
-
Evaluating 6-months of HER2-targeted Therapy in Patients With HER2 Positive Early-stage Breast Cancer That Achieve a Pathological Complete Response to Neoadjuvant Systemic Therapy
NCT04928261 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer
NCT00038402 ·Status: COMPLETED ·Phase: PHASE3
-
Safety of Herceptin/Trastuzumab in Metastatic Breast Cancer
NCT02424682 ·Status: COMPLETED
-
Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for HER2 Positive Early Breast Cancer Patients
NCT04750122 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast
NCT00496808 ·Status: COMPLETED ·Phase: NA
-
A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer
NCT03674112 ·Status: COMPLETED ·Phase: PHASE2
-
Probability of OncotypeDx to Reallocate As Low or High Risk of Recurrence Breast Cancer Patients with Uncertain Biology
NCT06363812 ·Status: COMPLETED
-
Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients
NCT04293393 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Efficacy Study of Herceptin to Treat HER2-negative CTC Breast Cancer
NCT01548677 ·Status: COMPLETED ·Phase: PHASE2