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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN97330959 | |||
| Main REC: 07/Q0603/67 | |||
| CTA: 22138/0004/001-0001 | |||
| EudraCT Number: 2006-004470-26 |
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| Name | Class |
|---|---|
| King's College London | OTHER |
| Cancer Research UK | OTHER |
| Breakthrough Breast Cancer | OTHER |
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The purpose of this study is to determine whether there is greater activity for carboplatin than a taxane standard of care (docetaxel) in women with ER-, PR- and HER2- breast cancer. The trial aims to recruit between 370 and 450 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Carboplatin |
|
| Arm B | Active Comparator | Docetaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | AUC 6 every 3 weeks for six cycles (18 weeks) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Response: Response will be evaluated after three and six cycles of chemotherapy using modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria, with appropriate clinical assessment and radiological investigations. | Time from start of treatment to 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression: this will be defined according to RECIST criteria and will be measured from the start of treatment until the confirmation of progression | Time from start of treatment until confirmation of progression | |
| Progression free survival: this will be defined according to RECIST criteria and will be measured from the start of treatment until the confirmation of progression or death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Tutt, MB ChB, MRCP, FRCR, PhD | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's and St Thomas' Hospital NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29713086 | Background | Tutt A, Tovey H, Cheang MCU, Kernaghan S, Kilburn L, Gazinska P, Owen J, Abraham J, Barrett S, Barrett-Lee P, Brown R, Chan S, Dowsett M, Flanagan JM, Fox L, Grigoriadis A, Gutin A, Harper-Wynne C, Hatton MQ, Hoadley KA, Parikh J, Parker P, Perou CM, Roylance R, Shah V, Shaw A, Smith IE, Timms KM, Wardley AM, Wilson G, Gillett C, Lanchbury JS, Ashworth A, Rahman N, Harries M, Ellis P, Pinder SE, Bliss JM. Carboplatin in BRCA1/2-mutated and triple-negative breast cancer BRCAness subgroups: the TNT Trial. Nat Med. 2018 May;24(5):628-637. doi: 10.1038/s41591-018-0009-7. Epub 2018 Apr 30. | |
| 37574209 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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| Docetaxel |
| Drug |
100mg/m2 every 3 weeks for six cycles (18 weeks) |
|
| Time from start of treatment until confirmation of progression or death |
| Time to treatment failure: this will be defined as time from randomisation to discontinuation of protocol treatment for any reason, or progression of disease as defined by RECIST | Time from randomisation to discontinuation of protocol treatment for any reason, or progression of disease |
| Overall survival: this will be defined as time from randomisation until death from any cause in the intention to treat population | Time from randomisation until death from any cause |
| Toxicity will be assessed throughout the treatment period using the National Cancer Institute Common Terminology Criteria for Adverse Events version three (NCI CTCAE v3.0) | Time from start of treatment to 18 weeks |
| Derived |
| Tovey H, Sipos O, Parker JS, Hoadley KA, Quist J, Kernaghan S, Kilburn L, Salgado R, Loi S, Kennedy RD, Roxanis I, Gazinska P, Pinder SE, Bliss J, Perou CM, Haider S, Grigoriadis A, Tutt A, Cheang MCU. Integrated Multimodal Analyses of DNA Damage Response and Immune Markers as Predictors of Response in Metastatic Triple-Negative Breast Cancer in the TNT Trial (NCT00532727). Clin Cancer Res. 2023 Sep 15;29(18):3691-3705. doi: 10.1158/1078-0432.CCR-23-0370. |
| 33098992 | Derived | Sipos O, Tovey H, Quist J, Haider S, Nowinski S, Gazinska P, Kernaghan S, Toms C, Maguire S, Orr N, Linn SC, Owen J, Gillett C, Pinder SE, Bliss JM, Tutt A, Cheang MCU, Grigoriadis A. Assessment of structural chromosomal instability phenotypes as biomarkers of carboplatin response in triple negative breast cancer: the TNT trial. Ann Oncol. 2021 Jan;32(1):58-65. doi: 10.1016/j.annonc.2020.10.475. Epub 2020 Oct 21. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |