Addition of Vismodegib to Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients
SHH-CM
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
1 other identifier
interventional
40
1 country
1
Brief Summary
To evaluate safety and efficacy of vismodegib with standard neoadjuvant chemotherapy in breast cancer patients based on the CTCAE v4 2010
- 1.To study changes in biomarkers involved in the Hedgehog (HH) pathway in the first biopsy as compared to the later one
- 2.To detect predictive factors among patients who reached pathological complete response (pCR) as compared to those with no pCR
- 3.To evaluate the role of the addition of vismodegib in the pCR rate
- 4.To evaluate clinical responses by breast MRI and rates of breast conservative surgery after neoadjuvant chemotherapy
- 5.To evaluate QOL with EORTC QLQ-C30 scale
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2016
CompletedFirst Posted
Study publicly available on registry
February 29, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 24, 2017
October 1, 2017
1.7 years
January 12, 2016
October 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0
21 months
Secondary Outcomes (4)
Molecular changes in breast
30 months
Pathologic complete response (pCR)
30 months
Clinical complete response (cCR)
21 months
European Organisation for Research and Treatment of Cancer Quality of Life questionnaire C30 (EORTC QOL-C30)
30 months
Study Arms (2)
vismodegib plus chemotherapy
EXPERIMENTALVismodegib 150 mg orally during paclitaxel and then dose dense epirubicin + cyclophosphamide (EC) therapy (see active comparator arm)
chemotherapy
ACTIVE COMPARATORPaclitaxel 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
Interventions
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
dose dense Epirubicin (90 mg/m2) plus Cyclophosphamide each 2 weeks x 4 doses with GMCSF after Paclitaxel
dose dense Cyclophosphamide (600 mg/m2) together with Epirubicin each 2 weeks x 4 doses with GMCSF after Paclitaxel
Eligibility Criteria
You may qualify if:
- Female sex
- Ability to give informed agreement and to carry out the whole study protocol during the study period
- The patient should be able to carry out the needs of the clinical trial and have measurable disease
- The patient should be 18-75 year-old
- Triple negative breast cancer (ER\<1%, Progesteron Receptor (PR)\<1%, non-overexpressing HER2). 1. Patients with oligometastatic disease (1-2 resectable metastases) could be included
- No previous systemic therapies
- Patients who are going to benefit from neoadjuvant chemotherapy
- Eastern Cooperative Oncology Group (ECOG)\<2 or Karnofsky≥70%
- Blood tests and biochemistry suitable: (absolute neutrophil count\> 1500/uL; haemoglobin\>9 gr/dL; platelets\>100000/uL (microliters); total bilirubin≤ 1.5 the upper normal limit; GOT and GPT (transaminases)≤twice the upper normal limit; fasting glucose≤150 gr/dL; HbA1c≤8%, serum creatinine≤2 mg/dL.
You may not qualify if:
- Severe diseases or infectious diseases or liver, kidney or bone marrow failure that advise not to participate in the study according to investigator criteria
- Pregnancy or breast feeding period or fertility women who are not agree with contraception methods
- Other primary tumors except for breast in situ carcinoma (CIS), cervical neoplasia(CIN) or localized skin tumors
- Inflammatory breast cancer or bilateral breast cancer
- Bone fractures, peptic ulcus or healing disorders
- Any local or systemic therapy for breast cancer
- To be maintained on immunosuppressants (prednisone \> 10 mgr daily or others), aspirin\> 325 mgr per day or clopidogrel \> 75 mgr daily
- Cardiomyopathy by New York Heart Association (NYHA) class II-IV; heart stroke in the previous 6 months; uncontrolled blood pressure (systolic \> 150 mm Hg and /or diastolic \> 100 mm Hg), coagulopathy or hemorrhagic diseases
- Previous lung diseases
- Personal history of abdominal perforation, abdominal abscess, or abdominal fistula.
- Inability to swallow pills
- Intolerance to galactose, malabsorption to galactose or/and glucose, or primary hypolactasia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clínica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Santisteban Marta, Doctor
Staff of the department of Oncology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2016
First Posted
February 29, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
October 24, 2017
Record last verified: 2017-10