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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01358877 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 4,804 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (522% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is \[i.e.\], an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); dis
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 |
What the finished NCT01358877 record still lists
NCT01358877 is an interventional study that assigns participants to a tested intervention. Its 4,804 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (522% higher).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01358877 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01358877's enrollment target sits among peer trials
4,804 53rd of 2000 higher than 1,948 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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