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A phase 3 trial of Cyclophosphamide, Docetaxel, Doxorubicin, Paclitaxel / nab-paclitaxel, Trastuzumab and Trastuzumab biosimilars in Breast cancer, run by National Cancer Institute (NCI), completed.
Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer is a phase 3 interventional study registered as NCT01275677 by National Cancer Institute (NCI), with 3270 participants recorded, started 2011-02-08 and reaching its primary completion in 2017-07-31. Interventions recorded: Cyclophosphamide, Docetaxel, Doxorubicin, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Paclitaxel, Quality-of-Life Assessment, Trastuzumab. Conditions recorded: HER2/Neu Positive, Progesterone Receptor Positive, Recurrent Breast Carcinoma, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7.
Linked to the drug Trastuzumab biosimilars because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
3,270 enrolled.
Figures from the ClinicalTrials.gov results section (first posted 2020-09-23), not from a publication
SourceFigures from the ClinicalTrials.gov results section (first posted 2020-09-23), not from a publication
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Percentage of Patients Alive and Free From Invasive Disease (IDFS)primary | Arm I (Chemotherapy) | 1,602 | 89.2% | - | - | link |
| Arm II (Chemotherapy, Trastuzumab) | 1,598 | 89.8% | ||||
| Percentage of Patients Alive (Overall Survival) | Arm I (Chemotherapy) | 1,603 | 96.3% | - | - | link |
| Arm II (Chemotherapy, Trastuzumab) | 1,602 | 94.8% |
Shares Trastuzumab, Doxorubicin, Cyclophosphamide, Paclitaxel / nab-paclitaxel and the tag pipeline.
Shares Trastuzumab biosimilars, Trastuzumab, Paclitaxel / nab-paclitaxel, Breast cancer (all types) and the tag pipeline.
Shares Trastuzumab biosimilars, Trastuzumab, Docetaxel, Breast cancer (all types) and the tag pipeline.
Shares Trastuzumab biosimilars, Trastuzumab and the tag pipeline.
Shares Trastuzumab, Docetaxel, Cyclophosphamide, Breast cancer (all types) and the tag pipeline.
Shares Docetaxel, Cyclophosphamide, Paclitaxel / nab-paclitaxel, Breast cancer (all types) and the tag pipeline.
Shares Docetaxel, Cyclophosphamide, Breast cancer (all types) and the tag pipeline.
Shares Paclitaxel / nab-paclitaxel, Breast cancer (all types) and the tag pipeline.