A Clinical Trial for Newly Diagnosed High Risk Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer : A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer(CheckMate 7FL: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 7FL) - Nivo/Placebo with Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in ER+/HER2-Breast Cancer
| Medienart: |
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Klinische Studie| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
WHO International Clinical Trials Registry Platform - (2023) vom: 21. Juni Zur Gesamtaufnahme - year:2023 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Anmerkungen: |
WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 19-12-2019, Last updated: 2023-06-29 |
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| ICTRP ID: |
EUCTR2019-002469-37-BE |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG005788250 |
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| 245 | 1 | 0 | |a A Clinical Trial for Newly Diagnosed High Risk Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer |b A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer(CheckMate 7FL: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 7FL) - Nivo/Placebo with Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in ER+/HER2-Breast Cancer |
| 264 | 1 | |c 2023 | |
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| 500 | |a WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 19-12-2019, Last updated: 2023-06-29 | ||
| 650 | 4 | |a Medical Condition: Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer MedDRA version: 21.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1Level: PTClassification code 10061020Term: Breast cancer maleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Cancer [C04] | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Phase: Phase 3 | |
| 650 | 4 | |a Recruitment Status: Authorised-recruitment may be ongoing or finished | |
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