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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001287-35-ES

Enrollment

Registered

2014-11-13

Start date

2015-03-12

Completion date

Unknown

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer MedDRA version: 17.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.1 Level: PT Classification code 10006200 Term: Breast cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.1 Level: PT Classification code 10006202 Term: Breast cancer stage IV System Organ Class:

Interventions

Trade Name: ERIVEDGE Product Name: Erivedge Pharmaceutical Form: Capsule, hard

Eligibility

Sex/Gender

All

Inclusion 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 (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 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

Exclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate safety and efficacy of vismodegib with standard neoadjuvant chemotherapy in breast cancer patients based on the CTCAE v4 2010 scale.;Secondary Objective: 1- To study changes in biomarkers involved in the 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;Primary end point(s): Se recogerán datos de seguridad y tolerabilidad de vismodegib en combinación con el esquema de quimioterapia neoadyuvante en pacientes con cáncer de mama. Se recogerán datos tanto de las notificaciones espontáneas de los pacientes como de los derivados de las distintas pruebas realizadas.;Timepoint(s) of evaluation of this end point: Markers of safety ans efficacy will be collected whith each systemic therapy. Toxicity will be evaluated based on CTCAE v4 2010 scale.	—

Measure

Time frame

Main Objective: To evaluate safety and efficacy of vismodegib with standard neoadjuvant chemotherapy in breast cancer patients based on the CTCAE v4 2010 scale.;Secondary Objective: 1- To study changes in biomarkers involved in the 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;Primary end point(s): Se recogerán datos de seguridad y tolerabilidad de vismodegib en combinación con el esquema de quimioterapia neoadyuvante en pacientes con cáncer de mama. Se recogerán datos tanto de las notificaciones espontáneas de los pacientes como de los derivados de las distintas pruebas realizadas.;Timepoint(s) of evaluation of this end point: Markers of safety ans efficacy will be collected whith each systemic therapy. Toxicity will be evaluated based on CTCAE v4 2010 scale.

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Secondary

Measure	Time frame
Secondary end point(s): 1- Biomarkers related to HH pathway. A molecular study base don qPCR or NGS and IHC will be performed in the diagnostic biopsy and the later one, before 2nd cycle of paclitaxel (frozen and FFPE tissue) Statystical analysis will be stratified accoridng to pCR, TNM staging and molecular markers Other biomarkers that will be evaluates are: ki67, GLI1, SMO, Patch, Cyclin D1, Claudine 1, p16, Snail, E-cadherin, CD44, CD24, ALDH1, MMP, CD25 and Foxp3 2- Based on Miller&Paine classification we will classified pathological CR in the breast, axilla and total (breast + axilla). pCR in the breast is defined as the abscensce of infiltrant carcinoma or residual CIS (in situ carcinoma) 3- Clinical response 4- Clinical response by breast MRI (breast and axilla) as well as perfussion imaging 5- QOL based on EORTC QLQ-C30 (at diagnosis and by the end of systemic therapies) 6- DFS and OS (out of the study we will perform a phone-based follow-up);Timepoint(s) of evaluation of this end point: 1- Biomarker analysis will be performed centralized at CIMA diagnostics by the completion of the pilot study when every sample of every patient is available 2- pCR will be measured after the surgery in the pathological sample by the Miller&Paine classification 3- To evaluate clinical response we will employ physical exploration, and imaging by the diagnosis and by the end of neoadjuvant therapy prior to surgery 4- Clinical response by breast ultrasound/MRI presurgery will be also stratified by therapy ( taxanes ± vismodegib) 5- QOL by the start and by the end of chemotherapy 6- DFS and OS will be studied out of this pilot study	—

Measure

Time frame

Secondary end point(s): 1- Biomarkers related to HH pathway. A molecular study base don qPCR or NGS and IHC will be performed in the diagnostic biopsy and the later one, before 2nd cycle of paclitaxel (frozen and FFPE tissue) Statystical analysis will be stratified accoridng to pCR, TNM staging and molecular markers Other biomarkers that will be evaluates are: ki67, GLI1, SMO, Patch, Cyclin D1, Claudine 1, p16, Snail, E-cadherin, CD44, CD24, ALDH1, MMP, CD25 and Foxp3 2- Based on Miller&Paine classification we will classified pathological CR in the breast, axilla and total (breast + axilla). pCR in the breast is defined as the abscensce of infiltrant carcinoma or residual CIS (in situ carcinoma) 3- Clinical response 4- Clinical response by breast MRI (breast and axilla) as well as perfussion imaging 5- QOL based on EORTC QLQ-C30 (at diagnosis and by the end of systemic therapies) 6- DFS and OS (out of the study we will perform a phone-based follow-up);Timepoint(s) of evaluation of this end point: 1- Biomarker analysis will be performed centralized at CIMA diagnostics by the completion of the pilot study when every sample of every patient is available 2- pCR will be measured after the surgery in the pathological sample by the Miller&Paine classification 3- To evaluate clinical response we will employ physical exploration, and imaging by the diagnosis and by the end of neoadjuvant therapy prior to surgery 4- Clinical response by breast ultrasound/MRI presurgery will be also stratified by therapy ( taxanes ± vismodegib) 5- QOL by the start and by the end of chemotherapy 6- DFS and OS will be studied out of this pilot study

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Countries

Spain

Contacts

Public ContactUCICEC

Clinica Universidad de Navarra

ucicec@unav.es34948255 4001144

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026