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NCT01358877 · ClinicalTrials.gov registry record · Phase 3
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,804
- Enrollment target
NCT01358877 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 4,804 participants.
The verdict
NCT01358877, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,804 participants
- Enrollment target
Study Summary
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).
Interventions
- DRUG Cyclophosphamide
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Doxorubicin
- DRUG 5-Fluorouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,804 participants |
| Start Date | 2011-11-08 |
| Est. Completion | 2024-11-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01358877
The ClinicalTrials.gov registry entry for NCT01358877 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,804 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01358877 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01358877 about?
NCT01358877 is a clinical study titled "A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer". This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with ...
What is the current status of trial NCT01358877?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,804 participants. The study started on 2011-11-08. Estimated completion is 2024-11-28.
What interventions are being tested in trial NCT01358877?
The interventions under investigation include: Cyclophosphamide (DRUG), Carboplatin (DRUG), Docetaxel (DRUG), Doxorubicin (DRUG), 5-Fluorouracil (DRUG).
Who is sponsoring clinical trial NCT01358877?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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