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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| Amgen | INDUSTRY |
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2 different treatment schedules may be used for neoadjuvant chemotherapy in breast cancer using adriamycin, cyclophosphamide and taxotere. The most optimal sequence- concurrent or sequential- is however unclear. The aim of the study is to compare the efficacy and tolerability of neoadjuvant chemotherapy with AC followed by T(adriamycin, cyclophosphamide, taxotere) versus TAC ( with upfront T) in patient with large resectable or locally advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Cycles 1-4 q 3 weeks: doxorubicin plus cyclophosphamide Cycles 5-8 q 3 weeks: docetaxel |
|
| B | Experimental | Cycles 1-6 q 3 weeks: doxorubicin, cyclophosphamide and docetaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxorubicin | Drug | doxorubicin (arm A:60 mg/m2) and arm B: 50 mg/m2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The pathologic complete response rate to neoadjuvant chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| The delivered chemotherapy dose and dose-intensity of both chemotherapy regimens | ||
| The tolerability (grade 3/4 CTC toxicities) of both chemotherapy regimens. | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| V.C.G. Tjan-Heijnen | AZM Maastricht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | Netherlands | ||||
| Onze Lieve Vrouwe Gasthuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28674765 | Derived | Vriens BEPJ, Vriens IJH, Aarts MJB, van Gastel SM, van den Berkmortel FWPJ, Smilde TJ, van Warmerdam LJC, van Spronsen DJ, Peer PGM, de Boer M, Tjan-Heijnen VCG; Breast Cancer Trialists' Group of the Netherlands (BOOG). Improved survival for sequentially as opposed to concurrently delivered neoadjuvant chemotherapy in non-metastatic breast cancer. Breast Cancer Res Treat. 2017 Oct;165(3):593-600. doi: 10.1007/s10549-017-4364-8. Epub 2017 Jul 3. | |
| 26650831 |
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| Cyclophosphamide | Drug | Cyclophosphamide: (arm A; 6000 mg/m2) an (arm B: 500 mg/m2) |
|
|
| Docetaxel | Drug | Docetaxel: (arm A: 100 mg/m2) and (arm B: 75 mg/m2) |
|
|
| The clinical responses of neoadjuvant chemotherapy correlated to pathological responses after neoadjuvant chemotherapy. |
| The value of breast MRI in evaluating response to neoadjuvant chemotherapy as compared to clinical palpation, ultrasound techniques and histo-pathological outcome. |
| The false-negative rate of the sentinel node biopsy after neoadjuvant chemotherapy. |
| The disease-free and overall survival after 3 and 5 years follow-up. |
| The relation between pCR and DFS/OS. |
| The feasibility of the criteria for reporting pathological tumour response in surgical breast and axillary node resection specimens. |
| The prognostic and predictive value of tumour- and molecular markers, including ER, PgR, c-erbB2, microarray and other tumour characteristic analyses. |
| Amsterdam |
| Netherlands |
| Rijnstate Ziekenhuis | Arnhem | Netherlands |
| Deventer Ziekenhuis | Deventer | Netherlands |
| Slingeland Hospital | Doetinchem | Netherlands |
| Catharina Ziekenhuis | Eindhoven | Netherlands |
| St. Anna Hospital | Geldrop | Netherlands |
| St. Jansdal Ziekenhuis | Harderwijk | Netherlands |
| Atrium Medisch Centrum | Heerlen | Netherlands |
| Elkerliek Ziekenhuis | Helmond | Netherlands |
| Spaarne Ziekenhuis | Hoofddorp | Netherlands |
| Leids Universitair Medisch Centrum (LUMC) | Leiden | Netherlands |
| Academical Hospital Maastricht (AZM) | Maastricht | Netherlands |
| St. Antonius Hospital | Nieuwegein | Netherlands |
| Canisius Wilhelmina Ziekenhuis | Nijmegen | Netherlands |
| Radboud University Medical Centre | Nijmegen | Netherlands |
| Waterland Hospital | Purmerend | Netherlands |
| Maasland Hospital | Sittard | Netherlands |
| HAGA Ziekenhuis | The Hague | Netherlands |
| St. Elisabeth Ziekenhuis | Tilburg | Netherlands |
| Mesos Medisch Centrum | Utrecht | Netherlands |
| UMC Utrecht | Utrecht | Netherlands |
| Maxima Medisch Centrum | Veldhoven | Netherlands |
| Zaans Medical Centre | Zaandam | Netherlands |
| Derived |
| Vriens BE, de Vries B, Lobbes MB, van Gastel SM, van den Berkmortel FW, Smilde TJ, van Warmerdam LJ, de Boer M, van Spronsen DJ, Smidt ML, Peer PG, Aarts MJ, Tjan-Heijnen VC; INTENS Study Group. Ultrasound is at least as good as magnetic resonance imaging in predicting tumour size post-neoadjuvant chemotherapy in breast cancer. Eur J Cancer. 2016 Jan;52:67-76. doi: 10.1016/j.ejca.2015.10.010. Epub 2015 Nov 30. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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