Clinical trial NCT02613208: A Study to Develop Predictive and Prognostic Tools for Optimizing Therapy With Bevacizumab Frontline Cancer Therapy in Participants With HER 2-Negative Aggressive Metastatic Breast Cancer
Official title: Observational and Prospective Study to Develop Predictive and Prognostic Tools for Optimizing Therapy With Bevacizumab Frontline Cancer Therapy in Patients With Metastatic HER 2-Negative and Aggressive Disease Criteria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-24
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with human epidermal growth factor receptor 2 (HER2)-negative aggressive metastatic breast cancer treated with standard first line chemotherapy with paclitaxel-bevacizumab.

Brief summary: This multicenter, observational, prospective study will identify a powerful and easy predictive/prognostic marker to use with participants under bevacizumab.


Eligibility criteria: Inclusion Criteria:

* Participants with HER2-negative metastatic breast cancer. Mandatory to have the HER2/estrogen receptor (ER)/progesterone receptor (PR) status
* Participant who met criteria for first-line treatment with chemotherapy plus bevacizumab (standard doses) by local, regional or national guidelines or authorities
* Participants with measurable disease (RECIST criteria v1.1) or participants with no measurable but assessable disease
* Molecular phenotype as triple negative metastatic breast cancer; and ER-positive tumors need to fulfill at least one of the two clinical criteria: metastatic relapse on adjuvant endocrine therapy or progression to at least one prior line of endocrine therapy for advanced disease; or aggressive disease criteria (at least two criteria): taxane based regimen in the (neo) adjuvant setting; metastatic relapse within 2 years from the end of chemotherapy for early breast cancer; liver metastasis; three or more organs with metastatic involvement; symptomatic visceral disease
* Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

* Participant has received prior chemotherapy for metastatic disease
* Participant requiring major/minor surgery within 3 weeks prior to administration of the first dose of study treatment
* Participant has received an investigational therapy within 4 weeks prior to study entry
* Participant has known symptomatic brain metastases
* Participant with non-measurable or assessable disease: exclusive blastic bone disease; pleural, pericardial or abdominal effusion as only evidence of disease
* Participant in chronic daily treatment with corticosteroids (doses greater than \[\>\]10 milligrams per day \[mg/day\] of methylprednisolone or equivalent), except inhaled steroids
* Pregnant or breastfeeding participant
* Women of childbearing potential who are not using hormonal contraceptives or highly effective birth control during the study
* Participant has an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
* Participant with significant renal, hematological or liver function alteration according to investigator's criteria
* Participant has serious medical risk factors involving any of the major organ systems

Primary outcomes:
measure: Percentage of Participants With Clinical Benefit
timeFrame: During follow-up (up to 18 months)
Secondary outcomes:
measure: Percentage of Participants With Overall Response as Assessed Using RECIST v1.1
timeFrame: From Baseline up to end of study (up to 18 months)
measure: Progression Free Survival (PFS) as Assessed Using RECIST v1.1
timeFrame: From Baseline up to end of study (up to 18 months)
measure: Overall Survival
timeFrame: From Baseline up to end of study (up to 18 months)
measure: Percentage of Participants With Adverse Events of Toxicity Grading 3 and/or 4
timeFrame: From Baseline up to end of study (up to 18 months)
measure: Optimal Cut-off for Clinical Benefit
timeFrame: Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days)
measure: Percentage of Participants With Overall Response (OR) as Assessed Using RECIST v1. in Prognostic Groups
timeFrame: Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days)
measure: PFS as Assessed Using RECIST v1. in Prognostic Groups
timeFrame: From Baseline up to end of study (up to 18 months)
measure: Mean CTC Count Levels
timeFrame: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])
measure: Mean Carcinoembryonic Antigen (CEA) Levels
timeFrame: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])
measure: Mean Biomarker Cancer Antigen 15.3 (CA 15.3) Level
timeFrame: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])
Other outcomes:
Locations:
city: Castellon de La Plana
country: Spain
facility: Hospital Provincial de Castellon; Servicio de Oncologia
state: Castellon
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Oncologia
state: Cordoba
city: San Sebastián
country: Spain
facility: Hospital de Donostia.; Servicio de Oncología Radioterápica
state: Guipuzcoa
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases; Servicio de Oncologia
state: Islas Baleares
city: La Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
state: LA Coruña
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
state: LAS Palmas
city: Barcelona
country: Spain
facility: Hospital Quiron Barcelona; Servicio de Oncologia
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia
city: Lerida
country: Spain
facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
city: Lugo
country: Spain
facility: Hospital Lucus Augusti; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa; Servicio de Oncologia
city: Madrid
country: Spain
facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Oncologia
city: Murcia
country: Spain
facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
city: Navarra
country: Spain
facility: Hospital de Navarra; Servicio de Oncologia
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
city: Segovia
country: Spain
facility: Hospital General de Segovia; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset; Servicio de Oncologia
city: Zamora
country: Spain
facility: Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio Oncologia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: