A randomized phase II pilot study to evaluate safety and efficacy of the addition of vismodegib to standard neoadjuvant chemotherapy in triple negative breast cancer patients.
- Conditions
- Breast cancerMedDRA version: 17.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: PTClassification code 10006200Term: Breast cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: PTClassification code 10006202Term: Breast cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: PTClassification code 10006201Term: Breast cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: PTClassification code 10006199Term: Breast cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-001287-35-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 40
1.Female sex
2.Ability to give informed agreement and to carry out the whole study protocol during the study period
3.The patient (sólo ella, no él, cámbialo en español también) should be able to carry out the needs of the clinical trial and have measurable disease
4.The patient should be 18-75 year-old
5.Triple negative breast cancer (ER<1%, PR<1%, non-overexpressing HER2). 1.Patients with oligometastatic disease (1-2 resectable metastases) could be included
6.No previous systhemic therapies
7.Patients who are going to benefit from neoadjuvant chemotherapy
8.ECOG<2 or Karnofsky?70%
9.Blood tests and biochemistry suitable: (absolut neutrophil count> 1500/uL; haemoglobin>9 gr/dL; platelets>100000/uL; total bilirrubin?1.5 the upper normal limit; GOT and GPT?twice the upper normal limit; fasting glucose?150 gr/dL; HbA1c?8%, serum creatinine?2 mg/dL.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
1.Severe diseases or infectious diseases or liver, kidney or bone marrow failure that advise not to participate in the study according to investigator criteria
2.Pregnancy or breast feeding period or fertility women who are not agree with contraception methods
3.Other primary tumors except for breast CIS, CIN or localized skin tumors
4.Inflammatory breast cancer or bilateral breast cancer
5.Bone fractures, peptic ulcus or healing disorders
6.Any local or systhemic therapy for breast cancer
7.To be maintained on immunosuppressants (prednisone > 10 mgr daily or others), aspirine> 325 mgr per day or clopidrogel > 75 mgr daily
8.Cardiomyopathy NYHA class II-IV; heart stroke in the previous 6 months; uncontrolled blood pressure (systolic > 150 mm Hg and /or dyastolic > 100 mm Hg), coagulopathy or hemorragic diseases
9.Previous lung diseases
10.Personal history of abdominal perforation, abdominal abscess, or abdominal fistula.
11.Inability to swallow pills
12.Intolerance to galactose, malabsorption to galactose or/and glucose, or primary hipolactase
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method