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To evaluate safety and efficacy of vismodegib with standard neoadjuvant chemotherapy in breast cancer patients based on the CTCAE v4 2010
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vismodegib plus chemotherapy | Experimental | Vismodegib 150 mg orally during paclitaxel and then dose dense epirubicin + cyclophosphamide (EC) therapy (see active comparator arm) |
|
| chemotherapy | Active Comparator | Paclitaxel 80 mg/m2 weekly on days 1, 8 and 15 each 21 days x 12 doses and then dose dense E (90 mg/m2) plus cyclophosphamide (CPA) 600 mg/m2 each 2 weeks x 4 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vismodegib | Drug | Smo inhibitor |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with treatment-related adverse events as assessed by CTCAE v4.0 | 21 months |
| Measure | Description | Time Frame |
|---|---|---|
| Molecular changes in breast | 30 months | |
| Pathologic complete response (pCR) | 30 months | |
| Clinical complete response (cCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amaya Izal | Contact | +34948255400 | 2724 | aizal@unav.es |
| Joana Reis, Nurse | Contact | +34948255400 | 2759 | jreis@unav.es |
| Name | Affiliation | Role |
|---|---|---|
| Santisteban Marta, Doctor | Staff of the department of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Universidad de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
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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 |
|---|---|
| C538724 | HhAntag691 |
| D017239 | Paclitaxel |
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Paclitaxel | Drug | Paclitaxel (80 mg/m2) weekly x 12 doses followed by sequential dose dense Epirubicin (90 mg/m2) plus Cyclophosphamide (600 mg/m2) each 2 weeks x 4 doses with granulocyte macrophage colony stimulating factors (GM-CSF) support |
|
| Epirubicin | Drug | dose dense Epirubicin (90 mg/m2) plus Cyclophosphamide each 2 weeks x 4 doses with GMCSF after Paclitaxel |
|
| Cyclophosphamide | Drug | dose dense Cyclophosphamide (600 mg/m2) together with Epirubicin each 2 weeks x 4 doses with GMCSF after Paclitaxel |
|
| 21 months |
| European Organisation for Research and Treatment of Cancer Quality of Life questionnaire C30 (EORTC QOL-C30) | We will consider data related to quality of life such as weakness, appetite, physical health, physiological health, social relationships, environment etc | 30 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| 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 |