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Completed

NCT Number: 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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Son Espases; Servicio de Oncologia, Palma de Mallorca, Balearic Islands, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

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

paclitaxel

Drug

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

    Overall response = Complete Response (CR) + Partial Response (PR). Overall response was evaluated for the Sensitive group (CTC <5) and Resistant group (CTC ≥5).

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

    Time frame: From Baseline up to end of study (up to 18 months)

    PFS was evaluated for the Sensitive group (CTC <5) and Resistant group (CTC ≥5).

  3. Overall Survival

    Time frame: From Baseline up to end of study (up to 18 months)

    OS was evaluated for the Sensitive group (CTC <5) and Resistant group (CTC ≥5).

  4. 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)

    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.

  5. 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)

    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.

  6. 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)

    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.

  7. PFS as Assessed Using RECIST v1. in Prognostic Groups

    Time frame: From Baseline up to end of study (up to 18 months)

    An optimal cut-off point for the CTC count of 0.5 after 2 cycles of treatment was used to define the prognostic groups.

  8. Mean CTC Count Levels

    Time frame: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])

    CTC and CEA levels were compared to determine any correlation between the two. Both CTC count at baseline and at cycle 2 were considered.

  9. Mean Carcinoembryonic Antigen (CEA) Levels

    Time frame: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])

  10. 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])

    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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: Argo

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 24, 2015
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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