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A phase 3 trial of Carboplatin, Docetaxel, Goserelin / leuprolide, Pertuzumab, HLX11, Trastuzumab and Trastuzumab biosimilars in Breast cancer, run by National Cancer Institute (NCI), completed.
Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer is a phase 3 interventional study registered as NCT02003209 by National Cancer Institute (NCI), with 315 participants recorded, started 2014-02-18 and reaching its primary completion in 2016-10-31. Interventions recorded: Aromatase Inhibition Therapy, Carboplatin, Cytology Specimen Collection Procedure, Docetaxel, Goserelin Acetate, Laboratory Biomarker Analysis, Pertuzumab, Quality-of-Life Assessment, Therapeutic Conventional Surgery, Trastuzumab, Whole Breast Irradiation. Conditions recorded: HER2-Positive Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma, 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 IIIB 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.
315 enrolled.
Figures from the ClinicalTrials.gov results section (first posted 2023-06-12), not from a publication
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Percent of Patients With Pathological Complete Response (pCR) in the Breast and Post Therapy Lymph Nodesprimary | Arm I (Combination Chemotherapy, Surgery, Radiation) | 153 | 41.2% | - | - | link |
| Arm II (Chemo, Estrogen Deprivation, Surgery, Radiation) | 155 | 45.8% |
Shares Trastuzumab biosimilars, Trastuzumab, Docetaxel, Breast cancer (all types) and the tag pipeline.
Shares Pertuzumab, Trastuzumab, Carboplatin, Breast cancer (all types) and the tag pipeline.
Shares Trastuzumab biosimilars, Pertuzumab, Trastuzumab, Breast cancer (all types) and the tag pipeline.
Shares Trastuzumab biosimilars, Trastuzumab and the tag pipeline.
Shares Pertuzumab, Trastuzumab, Docetaxel and the tag pipeline.
Shares Pertuzumab, Trastuzumab, Docetaxel and the tag pipeline.
Shares Goserelin / leuprolide (ovarian function suppression), Breast cancer (all types) and the tag pipeline.
Shares Pertuzumab, Trastuzumab and the tag pipeline.