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

NCT02613208 | Completed Results

• 2 other identifiers: ML29756ROC-BEV-2015-01
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 25

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Clinical Benefit

  Clinical benefit was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). Clinical benefit is defined as partial or complete response as well as tumor stabilization for up to 24 weeks. Results for clinical benefit were reported for 2 groups based on Circulating Tumor Cells (CTC) Levels. The Sensitive group had CTC levels \<5 (\<5 CTCs in one of the two determinations) and Resistant group had CTC ≥5 (≥ 5 CTCs in the two determinations).

  During follow-up (up to 18 months)

Secondary Outcomes (10)

• Percentage of Participants With Overall Response as Assessed Using RECIST v1.1

  From Baseline up to end of study (up to 18 months)

• Progression Free Survival (PFS) as Assessed Using RECIST v1.1

  From Baseline up to end of study (up to 18 months)

• Overall Survival

  From Baseline up to end of study (up to 18 months)

• Percentage of Participants With Adverse Events of Toxicity Grading 3 and/or 4

  From Baseline up to end of study (up to 18 months)

• Optimal Cut-off for Clinical Benefit

  Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days)

Study Arms (1)

Participants With Metastatic Breast Cancer

Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment.

Drug: Bevacizumab; Drug: Paclitaxel

Interventions

Bevacizumab DRUG

Bevacizumab will be administered as per local clinical practice and local labeling.

Participants With Metastatic Breast Cancer

Paclitaxel DRUG

Paclitaxel will be administered as per local clinical practice and local labeling.

Participants With Metastatic Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (25)

Hospital Universitario Son Espases; Servicio de Oncologia

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Hospital Provincial de Castellon; Servicio de Oncologia

Castellon, Castellon, 12002, Spain

Location

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, Cordoba, 14004, Spain

Location

Hospital de Donostia.; Servicio de Oncología Radioterápica

San Sebastián, Guipuzcoa, 20014, Spain

Location

Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

A Coruña, LA Coruña, 15006, Spain

Location

Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

Las Palmas de Gran Canaria, LAS Palmas, 35016, Spain

Location

Hospital de Navarra; Servicio de Oncologia

Navarra, Navarre, 31008, Spain

Location

Hospital Quiron Barcelona; Servicio de Oncologia

Barcelona, 08024, Spain

Location

Hospital Universitario Virgen de las Nieves; Servicio de Oncologia

Granada, 18014, Spain

Location

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

Jaén, 23007, Spain

Location

Complejo Asistencial Universitario de Leon; Servicio de Oncologia

León, 24071, Spain

Location

Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

Lleida, 25198, Spain

Location

Hospital Lucus Augusti; Servicio de Oncologia

Lugo, 27003, Spain

Location

Hospital Universitario de la Princesa; Servicio de Oncologia

Madrid, 28006, Spain

Location

Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

Madrid, 28033, Spain

Location

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, 28041, Spain

Location

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, 28046, Spain

Location

Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia

Murcia, 30008, Spain

Location

Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

Murcia, 30120, Spain

Location

Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

Salamanca, 37007, Spain

Location

Hospital General de Segovia; Servicio de Oncologia

Segovia, 40002, Spain

Location

Hospital Universitario Virgen Macarena; Servicio de Oncologia

Seville, 41009, Spain

Location

Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

Valencia, 46015, Spain

Location

Hospital Universitario Dr. Peset; Servicio de Oncologia

Valencia, 46017, Spain

Location

Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio Oncologia

Zamora, 49021, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 24, 2015
• Study Start: December 9, 2015
• Primary Completion: December 3, 2018
• Study Completion: December 3, 2018
• Last Updated: February 17, 2020
• Results First Posted: January 18, 2020

Record last verified: 2020-02

Locations

ES (25)