Breast CancerPhase 2SHH-CMNCT02694224
Addition of Vismodegib to Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients
A Phase 2 study testing vismodegib, Paclitaxel and Epirubicin in people with Breast Cancer, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- vismodegib, Paclitaxel and Epirubicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
Amaya Izal, +34948255400 ext. 2724, aizal@unav.es
About this study
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
To evaluate safety and efficacy of vismodegib with standard neoadjuvant chemotherapy in breast cancer patients based on the CTCAE v4 2010
- To study changes in biomarkers involved in the Hedgehog (HH) pathway in the first biopsy as compared to the later one
- To detect predictive factors among patients who reached pathological complete response (pCR) as compared to those with no pCR
- To evaluate the role of the addition of vismodegib in the pCR rate
- To evaluate clinical responses by breast MRI and rates of breast conservative surgery after neoadjuvant chemotherapy
- To evaluate QOL with EORTC QLQ-C30 scale
- Conditions
- Breast Cancer
- Being tested
- vismodegib, Paclitaxel, Epirubicin, Cyclophosphamide
- Keywords
- breast cancer, triple negative, neoadjuvant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vismodegibDrug
Also called GDC0449
Smo inhibitor
PaclitaxelDrug
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
EpirubicinDrug
dose dense Epirubicin (90 mg/m2) plus Cyclophosphamide each 2 weeks x 4 doses with GMCSF after Paclitaxel
CyclophosphamideDrug
dose dense Cyclophosphamide (600 mg/m2) together with Epirubicin each 2 weeks x 4 doses with GMCSF after Paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| vismodegib plus chemotherapy | Experimental | Vismodegib 150 mg orally during paclitaxel and then dose dense epirubicin + cyclophosphamide (EC) therapy (see active comparator arm) Receives: Drug: vismodegib; Drug: Paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide |
| 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 Receives: Drug: Paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 21 months
Secondary outcomes (4)
Molecular changes in breast
Measured: 30 months
Pathologic complete response (pCR)
Measured: 30 months
Clinical complete response (cCR)
Measured: 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
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Santisteban Marta, Doctor, Principal investigator, Staff of the department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694224
- Sponsor's protocol ID
- SHH (Sonic HedgeHog)-CM
- Acronym
- SHH-CM
- Status last verified
- Oct 2017
- First submitted
- 12 Jan 2016
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02694224
- Acronym / sponsor ID
- SHH-CM / SHH (Sonic HedgeHog)-CM
- Conditions
- Breast Cancer
- Keywords
- breast cancer, triple negative, neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate safety and efficacy of vismodegib with standard neoadjuvant chemotherapy in breast cancer patients based on the CTCAE v4 2010
- To study changes in biomarkers involved in the Hedgehog (HH) pathway in the first biopsy as compared to the later one
- To detect predictive factors among patients who reached pathological complete response (pCR) as compared to those with no pCR
- To evaluate the role of the addition of vismodegib in the pCR rate
- To evaluate clinical responses by breast MRI and rates of breast conservative surgery after neoadjuvant chemotherapy
- To evaluate QOL with EORTC QLQ-C30 scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vismodegib plus chemotherapy | Experimental | Drug: vismodegib, Drug: Paclitaxel, Drug: Epirubicin, Drug: CyclophosphamideVismodegib 150 mg orally during paclitaxel and then dose dense epirubicin + cyclophosphamide (EC) therapy (see active comparator arm) |
| chemotherapy | Active comparator | Drug: Paclitaxel, Drug: Epirubicin, Drug: CyclophosphamidePaclitaxel 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vismodegibAlso: GDC0449Smo inhibitor | Drug | vismodegib plus chemotherapy |
| PaclitaxelPaclitaxel (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 | chemotherapy, vismodegib plus chemotherapy |
| Epirubicindose dense Epirubicin (90 mg/m2) plus Cyclophosphamide each 2 weeks x 4 doses with GMCSF after Paclitaxel | Drug | chemotherapy, vismodegib plus chemotherapy |
| Cyclophosphamidedose dense Cyclophosphamide (600 mg/m2) together with Epirubicin each 2 weeks x 4 doses with GMCSF after Paclitaxel | Drug | chemotherapy, vismodegib plus chemotherapy |
Primary outcome
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 21 months
4 secondary outcomes
Molecular changes in breast
Time frame: 30 months
Pathologic complete response (pCR)
Time frame: 30 months
Clinical complete response (cCR)
Time frame: 21 months
European Organisation for Research and Treatment of Cancer Quality of Life questionnaire C30 (EORTC QOL-C30)
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santisteban Marta, Doctor principal investigator
Staff of the department of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vismodegib, Paclitaxel and Epirubicin in people with Breast Cancer, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amaya Izal (+34948255400 ext. 2724, aizal@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.