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
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|ClinicalTrials.gov Identifier: NCT01964391|
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : April 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Trastuzumab Drug: Doxorubicin Drug: Cyclophosphamide Drug: Paclitaxel Drug: Docetaxel Drug: Carboplatin Drug: Neo-adjuvant chemotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||174 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Multinational, Multicenter, Phase IIIb Study With Subcutaneous Administration of Trastuzumab in Patients With HER2-Positive Early Breast Cancer to Evaluate Patient Satisfaction|
|Actual Study Start Date :||February 21, 2014|
|Actual Primary Completion Date :||December 22, 2016|
|Actual Study Completion Date :||November 25, 2018|
In adjuvant setting trastuzumab will be administered in the following treatment regimens: (a) trastuzumab following surgery, chemotherapy (neo-adjuvant or adjuvant) and radiotherapy (if applicable); (b) trastuzumab following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel; (c) trastuzumab in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. In neo-adjuvant setting, trastuzumab will be administered in combination with neo-adjuvant chemotherapy followed by adjuvant trastuzumab, for locally advanced (including inflammatory) breast cancer or tumors greater than (>) 2 centimeters (cm) in diameter.
Trastuzumab will be administered subcutaneously at a fixed dose of 600 mg (irrespective of body weight) every 3 weeks for 1 year (adjuvant or neo-adjuvant plus adjuvant therapy).
Other Name: Herceptin
Doxorubicin will be administered in combination with trastuzumab and cyclophosphamide in the adjuvant setting as per local Product Information and the investigator's discretion.
Cyclophosphamide will be administered in combination with trastuzumab and doxorubicin in the adjuvant setting as per local Product Information and the investigator's discretion.
Paclitaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion.
Docetaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion.
Carboplatin will be administered in combination with trastuzumab and docetaxel in the adjuvant setting as per local Product Information and the investigator's discretion.
Drug: Neo-adjuvant chemotherapy
Neo-adjuvant chemotherapy will be administered according to local guidelines in combination with trastuzumab in the neo-adjuvant setting. The study protocol does not mention any specific neo-adjuvant chemotherapy drug names.
- Participant Satisfaction Questionnaire Score [ Time Frame: Week 52 ]
- Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to 4.5 years ]
- Healthcare Professional Experience and Satisfaction Questionnaire Score [ Time Frame: Week 52 ]
- Overall Survival (OS) [ Time Frame: Baseline until death from any cause (up to 4.5 years) ]
- Disease-Free Survival (DFS) [ Time Frame: Baseline until first documented disease or death, whichever comes first (up to 4.5 years) ]Diagnosis of breast cancer relapse will be made based on routine clinical, radiological and laboratory criteria. Acceptable methods of confirmation of recurrence include radiology, computed tomography (CT) scan, brain scan, ultrasound, or cytology, as per local practice. In case of uncertainty, disease relapse should be confirmed by histological or cytological examination of a suspicious lesion, if possible.
- Number of Days on Trastuzumab Treatment [ Time Frame: Baseline up to 1 year ]
- Total Daily Dose of Trastuzumab [ Time Frame: Baseline up to 1 year ]
- Cumulative Dose of Trastuzumab [ Time Frame: Baseline up to 1 year ]
- Duration of Treatment, Follow-up, and Safety Observation [ Time Frame: Baseline up to 4.5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964391
|Centre hospitalo-univerisitaire de Rouiba;Service d'oncologie médicale|
|Algiers, Algeria, 16016|
|Centre Anti Cancer Beau-fraisier;Service d'oncologie médicale|
|Algiers, Algeria, 16340|
|CHU Annaba; Service d'Oncologie Médicale|
|Annaba, Algeria, 23000|
|EHS Oncologie Emir Abdelkader Oran; Service d'Oncologie Médicale|
|Oran, Algeria, 31000|
|Casablanca, Morocco, 20052|
|Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie|
|Marrakech, Morocco, 40000|
|Institut National D'oncologie Sidi Med Benabdellah|
|Rabat, Morocco, 6213|
|International Medical Center (IMC)|
|Jeddah, Saudi Arabia, 21451|
|King Khaled Uni Hospital; Oncology|
|Riyadh, Saudi Arabia, 11472|
|Abderrahmen Mami Hospital; Medical Oncology department|
|Ariana, Tunisia, 2080|
|Habib Bourguiba Hospital; Oncology department|
|Sfax, Tunisia, 3029|
|Farhat Hached Hospital; Oncology department|
|Sousse, Tunisia, 4031|
|Institut Salah Azaïz; Service de Médecine Carcinologique|
|Tunis, Tunisia, 1029|
|Gazi University Medical Faculty; Department of İnternal Medicine|
|Ankara, Turkey, 06500|
|Akdeniz Univesity Medical Faculty|
|Antalya, Turkey, 07058|
|Dicle University Faculty of Medicine|
|Diyarbakir, Turkey, 21280|
|Trakya University Medical Faculty|
|Edirne, Turkey, 22030|
|Gaziantep Univ. Med. Fac.|
|Gaziantep, Turkey, 27310|
|İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi|
|İstanbul, Turkey, 34098|
|Bezmialem Vakif Univ Medical|
|Istanbul, Turkey, 34286|
|Marmara Uni Faculty of Medicine; Medical Oncology|
|Istanbul, Turkey, 34890|
|Ege University Medical Faculty|
|Izmir, Turkey, 35100|
|Hacettepe Uni Medical Faculty Hospital; Oncology Dept|
|Sıhhiye, Ankara, Turkey, 06100|
|Study Director:||Clinical Trials||Hoffmann-La Roche|