Breast CancerArgoNCT02613208
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
An observational study of Breast Cancer, run by Hoffmann-La Roche at 25 sites in Spain.
Trial summary
This multicenter, observational, prospective study will identify a powerful and easy predictive/prognostic marker to use with participants under bevacizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bevacizumab and Paclitaxel
- How many people
- 111 participants
- Where
- 25 sitesSpain
- Study dates
- 9 Dec 2015to 3 Dec 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Spain25 sites
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
A Coruña, LA Coruña, 15006
Hospital Quiron Barcelona; Servicio de Oncologia
Barcelona, 08024
Hospital Provincial de Castellon; Servicio de Oncologia
Castellon, Castellon, 12002
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, 14004
Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
Granada, 18014
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaén, 23007
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
Las Palmas de Gran Canaria, LAS Palmas, 35016
Complejo Asistencial Universitario de Leon; Servicio de Oncologia
León, 24071
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
Lleida, 25198
Hospital Lucus Augusti; Servicio de Oncologia
Lugo, 27003
Hospital Universitario de la Princesa; Servicio de Oncologia
Madrid, 28006
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
Madrid, 28033
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28046
Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
Murcia, 30008
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia, 30120
Hospital de Navarra; Servicio de Oncologia
Navarra, Navarre, 31008
Hospital Universitario Son Espases; Servicio de Oncologia
Palma de Mallorca, Balearic Islands, 07014
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
Salamanca, 37007
Hospital de Donostia.; Servicio de Oncología Radioterápica
San Sebastián, Guipuzcoa, 20014
Hospital General de Segovia; Servicio de Oncologia
Segovia, 40002
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Seville, 41009
Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
Valencia, 46015
Hospital Universitario Dr. Peset; Servicio de Oncologia
Valencia, 46017
Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio Oncologia
Zamora, 49021
About this study
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
This multicenter, observational, prospective study will identify a powerful and easy predictive/prognostic marker to use with participants under bevacizumab.
- Conditions
- Breast Cancer
- Being tested
- Bevacizumab, Paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Bevacizumab will be administered as per local clinical practice and local labeling.
PaclitaxelDrug
Paclitaxel will be administered as per local clinical practice and local labeling.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bevacizumab; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During follow-up (up to 18 months)
Secondary outcomes (10)
Percentage of Participants With Overall Response as Assessed Using RECIST v1.1
Overall response = Complete Response (CR) + Partial Response (PR). Overall response was evaluated for the Sensitive group (CTC <5) and Resistant group (CTC ≥5).
Measured: From Baseline up to end of study (up to 18 months)
Progression Free Survival (PFS) as Assessed Using RECIST v1.1
PFS was evaluated for the Sensitive group (CTC <5) and Resistant group (CTC ≥5).
Measured: From Baseline up to end of study (up to 18 months)
Overall Survival
OS was evaluated for the Sensitive group (CTC <5) and Resistant group (CTC ≥5).
Measured: From Baseline up to end of study (up to 18 months)
Percentage of Participants With Adverse Events of Toxicity Grading 3 and/or 4
Adverse events (AEs) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v 4.0). Any AEs that are not specifically listed in the NCI CTCAE follow the logic - Grade 3) Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4: Life-threatening consequences or urgent intervention indicated.
Measured: From Baseline up to end of study (up to 18 months)
Optimal Cut-off for 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. The optimal cut-off for clinical benefit was calculated from a Receiver Operating Curve (ROC) based on CTC level and used to define the prognostic factors that could better predict clinical outcomes.
Measured: Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days)
Percentage of Participants With Overall Response (OR) as Assessed Using RECIST v1. in Prognostic Groups
Overall response = CR + PR. An optimal cut-off point for the CTC count of 0.5 after 2 cycles of treatment was used to define the prognostic groups.
Measured: Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days)
PFS as Assessed Using RECIST v1. in Prognostic Groups
An optimal cut-off point for the CTC count of 0.5 after 2 cycles of treatment was used to define the prognostic groups.
Measured: From Baseline up to end of study (up to 18 months)
Mean CTC Count Levels
CTC and CEA levels were compared to determine any correlation between the two. Both CTC count at baseline and at cycle 2 were considered.
Measured: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])
Mean Carcinoembryonic Antigen (CEA) Levels
Measured: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])
Mean Biomarker Cancer Antigen 15.3 (CA 15.3) Level
CTC and CA 15.3 levels were compared to determine any correlation between the two. Both CTC count at baseline and at cycle 2 were considered.
Measured: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study start9 Dec 2015
- Primary completion3 Dec 2018
- Study completion3 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613208
- Sponsor's protocol ID
- ML29756
- Other IDs
- ROC-BEV-2015-01
- Acronym
- Argo
- Status last verified
- Feb 2020
- First submitted
- 20 Nov 2015
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02613208
- Acronym / sponsor ID
- Argo / ML29756
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2015 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, observational, prospective study will identify a powerful and easy predictive/prognostic marker to use with participants under bevacizumab.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With Metastatic Breast Cancer | – | Drug: Bevacizumab, Drug: PaclitaxelParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| BevacizumabBevacizumab will be administered as per local clinical practice and local labeling. | Drug | Participants With Metastatic Breast Cancer |
| PaclitaxelPaclitaxel will be administered as per local clinical practice and local labeling. | Drug | Participants With Metastatic Breast Cancer |
Primary outcome
Percentage of Participants With Clinical Benefit
Time frame: During follow-up (up to 18 months)
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).
10 secondary outcomes
Percentage of Participants With Overall Response as Assessed Using RECIST v1.1
Time frame: From Baseline up to end of study (up to 18 months)
Progression Free Survival (PFS) as Assessed Using RECIST v1.1
Time frame: From Baseline up to end of study (up to 18 months)
Overall Survival
Time frame: From Baseline up to end of study (up to 18 months)
Percentage of Participants With Adverse Events of Toxicity Grading 3 and/or 4
Time frame: From Baseline up to end of study (up to 18 months)
Optimal Cut-off for Clinical Benefit
Time frame: Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days)
Percentage of Participants With Overall Response (OR) as Assessed Using RECIST v1. in Prognostic Groups
Time frame: Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days)
PFS as Assessed Using RECIST v1. in Prognostic Groups
Time frame: From Baseline up to end of study (up to 18 months)
Mean CTC Count Levels
Time frame: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])
Mean Carcinoembryonic Antigen (CEA) Levels
Time frame: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])
Mean Biomarker Cancer Antigen 15.3 (CA 15.3) Level
Time frame: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Breast Cancer
Not yet recruiting
Decision Support for Chemoprevention
Breast Cancer
Active, not recruiting
Improving Patient-Centered Communication in Breast Cancer Through Patient and Provider Interventions
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
Not yet recruiting
Tolerability of Dalpiciclib vs. Abemaciclib/Ribociclib in Early HR+/HER2- Breast Cancer
Breast Cancer
Active, not recruitingObservational study
Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy
Breast Cancer, Lymphoma
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.
Clinical Trials study director
Hoffmann-La Roche
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Hoffmann-La Roche at 25 sites 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Clinical Benefit (time frame: During follow-up (up to 18 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 17 Feb 2020.