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This Phase IIIb, open-label, multinational, multicenter study will evaluate the participant's satisfaction and safety with subcutaneously administered trastuzumab in participants with HER2-positive early breast cancer. Participants will receive trastuzumab 600 milligrams (mg) administered subcutaneously every 3 weeks in the adjuvant or neo-adjuvant plus adjuvant setting for 18 cycles (1 year), unless disease progression or unacceptable toxicity occurs. The trastuzumab regimen could include mono- and/or combination therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction Questionnaire Score | Week 52 | |
| Percentage of Participants with Adverse Events (AEs) | Baseline up to 4.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Professional Experience and Satisfaction Questionnaire Score | Week 52 | |
| Overall Survival (OS) | Baseline until death from any cause (up to 4.5 years) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalo-univerisitaire de Rouiba;Service d'oncologie médicale | Algiers | 16016 | Algeria | |||
| Centre Anti Cancer Beau-fraisier;Service d'oncologie médicale |
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|
| Doxorubicin | Drug | 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 | Drug | 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 | Drug | Paclitaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion. |
|
| Docetaxel | Drug | Docetaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion. |
|
| Carboplatin | Drug | Carboplatin will be administered in combination with trastuzumab and docetaxel in the adjuvant setting as per local Product Information and the investigator's discretion. |
|
| Neo-adjuvant chemotherapy | Drug | 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. |
|
| Disease-Free Survival (DFS) |
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. |
| Baseline until first documented disease or death, whichever comes first (up to 4.5 years) |
| Number of Days on Trastuzumab Treatment | Baseline up to 1 year |
| Total Daily Dose of Trastuzumab | Baseline up to 1 year |
| Cumulative Dose of Trastuzumab | Baseline up to 1 year |
| Duration of Treatment, Follow-up, and Safety Observation | Baseline up to 4.5 years |
| Algiers |
| 16340 |
| Algeria |
| CHU Annaba; Service d'Oncologie Médicale | Annaba | 23000 | Algeria |
| EHS Oncologie Emir Abdelkader Oran; Service d'Oncologie Médicale | Oran | 31000 | Algeria |
| Clinique Littoral | Casablanca | 20052 | Morocco |
| Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie | Marrakesh | 40000 | Morocco |
| Institut National D'oncologie Sidi Med Benabdellah | Rabat | 6213 | Morocco |
| International Medical Center (IMC) | Jeddah | 21451 | Saudi Arabia |
| King Khaled Uni Hospital; Oncology | Riyadh | 11472 | Saudi Arabia |
| Abderrahmen Mami Hospital; Medical Oncology department | Aryanah | 2080 | Tunisia |
| Habib Bourguiba Hospital; Oncology department | Sfax | 3029 | Tunisia |
| Farhat Hached Hospital; Oncology department | Sousse | 4031 | Tunisia |
| Institut Salah Azaïz; Service de Médecine Carcinologique | Tunis | 1029 | Tunisia |
| Gazi University Medical Faculty; Department of İnternal Medicine | Ankara | 06500 | Turkey (Türkiye) |
| Akdeniz Univesity Medical Faculty | Antalya | 07058 | Turkey (Türkiye) |
| Dicle University Faculty of Medicine | Diyarbakır | 21280 | Turkey (Türkiye) |
| Trakya University Medical Faculty | Edirne | 22030 | Turkey (Türkiye) |
| Gaziantep Univ. Med. Fac. | Gaziantep | 27310 | Turkey (Türkiye) |
| İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi | Istanbul | 34098 | Turkey (Türkiye) |
| Bezmialem Vakif Univ Medical | Istanbul | 34286 | Turkey (Türkiye) |
| Marmara Uni Faculty of Medicine; Medical Oncology | Istanbul | 34890 | Turkey (Türkiye) |
| Ege University Medical Faculty | Izmir | 35100 | Turkey (Türkiye) |
| Hacettepe Uni Medical Faculty Hospital; Oncology Dept | Sıhhiye, Ankara | 06100 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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