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Trial record 34 of 78 for:    vismodegib

Addition of Vismodegib to Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients (SHH-CM)

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ClinicalTrials.gov Identifier: NCT02694224
Recruitment Status : Recruiting
First Posted : February 29, 2016
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: vismodegib Drug: Paclitaxel Drug: Epirubicin Drug: Cyclophosphamide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Vismodegib

Arm Intervention/treatment
Experimental: vismodegib plus chemotherapy
Vismodegib 150 mg orally during paclitaxel and then dose dense epirubicin + cyclophosphamide (EC) therapy (see active comparator arm)
Drug: vismodegib
Smo inhibitor
Other Name: GDC0449

Drug: Paclitaxel
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

Drug: Epirubicin
dose dense Epirubicin (90 mg/m2) plus Cyclophosphamide each 2 weeks x 4 doses with GMCSF after Paclitaxel

Drug: Cyclophosphamide
dose dense Cyclophosphamide (600 mg/m2) together with Epirubicin each 2 weeks x 4 doses with GMCSF after Paclitaxel

Active Comparator: chemotherapy
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
Drug: Paclitaxel
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

Drug: Epirubicin
dose dense Epirubicin (90 mg/m2) plus Cyclophosphamide each 2 weeks x 4 doses with GMCSF after Paclitaxel

Drug: Cyclophosphamide
dose dense Cyclophosphamide (600 mg/m2) together with Epirubicin each 2 weeks x 4 doses with GMCSF after Paclitaxel




Primary Outcome Measures :
  1. Number of patients with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 21 months ]

Secondary Outcome Measures :
  1. Molecular changes in breast [ Time Frame: 30 months ]
  2. Pathologic complete response (pCR) [ Time Frame: 30 months ]
  3. Clinical complete response (cCR) [ Time Frame: 21 months ]
  4. European Organisation for Research and Treatment of Cancer Quality of Life questionnaire C30 (EORTC QOL-C30) [ Time Frame: 30 months ]
    We will consider data related to quality of life such as weakness, appetite, physical health, physiological health, social relationships, environment etc



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female sex
  2. Ability to give informed agreement and to carry out the whole study protocol during the study period
  3. The patient 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%, Progesteron Receptor (PR)<1%, non-overexpressing HER2). 1. Patients with oligometastatic disease (1-2 resectable metastases) could be included
  6. No previous systemic therapies
  7. Patients who are going to benefit from neoadjuvant chemotherapy
  8. Eastern Cooperative Oncology Group (ECOG)<2 or Karnofsky≥70%
  9. 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.

Exclusion Criteria:

  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 in situ carcinoma (CIS), cervical neoplasia(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 systemic therapy for breast cancer
  7. To be maintained on immunosuppressants (prednisone > 10 mgr daily or others), aspirin> 325 mgr per day or clopidogrel > 75 mgr daily
  8. 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
  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 hypolactasia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694224


Contacts
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Contact: Amaya Izal +34948255400 ext 2724 aizal@unav.es
Contact: Joana Reis, Nurse +34948255400 ext 2759 jreis@unav.es

Locations
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Spain
Clínica Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Amaya Izal    +34948255400 ext 2724    aizal@unav.es   
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
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Principal Investigator: Santisteban Marta, Doctor Staff of the department of Oncology

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Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT02694224     History of Changes
Other Study ID Numbers: SHH (Sonic HedgeHog)-CM
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
breast cancer
triple negative
neoadjuvant

Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors