NCT01276899

Brief Summary

This is a multicenter translational study to understand therapeutic resistance in patients undergoing standard chemotherapy for triple negative breast cancer. In the neoadjuvant setting, biopsy tissue samples from primary tumor will be collected and banked before the start of chemotherapy and after the completion of the treatment (post-chemotherapy and at the time of surgery). In the metastatic setting, tissue samples from metastatic lesions will be collected and banked before the start of chemotherapy and at the time of tumor progression. Additionally, blood samples will be drawn before treatment initiation (baseline) and at different time points during treatment. All samples will be stored in the Biological Resource Repository.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

5 years

First QC Date

January 12, 2011

Last Update Submit

May 27, 2022

Conditions

Triple Negative Breast Cancer

Keywords

Breast CancerTriple negative breast cancerERnegative, PRnegative and Her2negativeTaxanesMetastasesBiomarkersResistanceBiobankingBreast cancer with unresectable metastases to the liverBreast cancer with unresectable metastases to the skinBreast cancer with unresectable metastases to the lymph nodeNeoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Biomarkers changes in patients that have been exposed to chemotherapy

    3 years

Secondary Outcomes (3)

  • Create a unique bank of biospecimens from patients with triple negative breast tumors comprising tumor material and plasma collected in a specific and well defined clinical context.

    2 years

  • Study mechanisms of resistance to chemotherapy by profiling for the first time resistant tumors in both the metastatic and advanced primary tumor settings.

    3 years

  • Identify biomarkers that will be used as predictors of therapeutic resistance in the tissue and blood of patients with triple negative breast tumors

    3 years

Study Arms (2)

Neoadjuvant setting

Procedure: Needle core biopsies

Metastatic setting

Procedure: Needle core biopsies of metastatic lesion

Interventions

Needle core biopsiesPROCEDURE

No investigational products will be administered to subjects as part of this translational research study. Needle core biopsies will be done to collect tumor samples. A taxane-based regimen will be administered as per the standard of care at each treating institution. Tissue samples from primary tumors will be collected and banked before the start of chemotherapy, after chemotherapy and at the time of surgery. Additionally, blood samples will be drawn before treatment initiation (baseline) and at different time points during treatment and stored in the tissue biobank.

Neoadjuvant setting
Needle core biopsies of metastatic lesionPROCEDURE

No investigational products will be administered to subjects as part of this translational research study. Needle core biopsies will be done to collect metastasis tumor samples. Chemotherapy will be administered as per the standard of care at each treating institution. Tissue samples from metastatic tumors lesions will be collected and banked before the start of chemotherapy and at the time of progression. Additionally, blood samples will be drawn before treatment initiation (baseline) and at different time points during treatment and stored in the tissue biobank.

Metastatic setting

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will be conducted in patients with a diagnosis of breast cancer and pathologically identified as triple negative (not expressing estrogen receptor (ER), progesterone receptor (PR) and HER2 protein, and not showing ERBB2 gene amplification) who will be undergoing neoadjuvant treatment or chemotherapy for metastatic disease.

You may qualify if:

  • Neoadjuvant setting
  • Histologically confirmed diagnosis of adenocarcinoma of the breast
  • Patient candidate for neoadjuvant chemotherapy (taxane-based)
  • Triple negative (ERnegative, PRnegative and Her2negative as defined by local standards)
  • Normal coagulation profile; including INR/ PTT ≤ 1.5 x ULN.
  • ECOG 0,1 or 2
  • Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Metastatic setting
  • Patients with histologically confirmed primary adenocarcinoma of the breast
  • Metastatic (stage IV) disease at initial diagnosis or following previous diagnosis of primary breast cancer
  • At least one metastatic site accessible for biopsy.
  • ER-negative, PgR negative and HER2 negative as per local standards
  • Scheduled to receive chemotherapy for triple negative metastatic breast cancer.
  • Measurable disease (at least one unidimensionally measurable lesion)
  • +5 more criteria

You may not qualify if:

  • Neoadjuvant setting
  • Positive for ER, PR or Her2 as defined by local standards
  • Clinical or radiological evidence of metastatic disease
  • Inadequate or unusable tissue as the only tissue available for biopsy
  • Other non-malignant systemic disease to preclude treatment with chemotherapy regimen or prevent follow-up
  • Diagnosis of inflammatory breast cancer
  • Known infection with HIV or hepatitis
  • Metastatic setting
  • Patients with ER+, PR+ or HER2+ tumors demonstrated by local standards
  • Inadequate or unusable tissue as the only tissue available for biopsy
  • Other non-malignant systemic disease to preclude treatment with standard chemotherapy regimen or prevent follow-up
  • Abnormal coagulation profile
  • The planned concurrent administration of therapies (e.g. palliative radiotherapy) that target metastatic sites accessible for biopsy
  • Known infection with HIV or hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, United States

Location

Centre Hospitalier de l'Université de Montréal -- Hotel-Dieu

Montreal, Quebec, Canada

Location

Centre Hospitalier de l'Université de Montréal- Notre-Dame

Montreal, Quebec, Canada

Location

Hôpital Royal Victoria

Montreal, Quebec, Canada

Location

Hôpital Sacré-Coeur

Montreal, Quebec, Canada

Location

Jewish General Hospital

Montreal, Quebec, Canada

Location

St-Mary's Hospital Center

Montreal, Quebec, Canada

Location

Hopital du St-Sacrement

Québec, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor samples from the primary breast tumor or metastatic lesions will be obtained by needle core biopsy. In the neoadjuvant setting, samples will be also collected at the time of surgery. To obtain sufficient material for tissue banking, four needle core biopsies will be removed from the same neoplastic lesion. Two of the biospecimens will be snap frozen for phosphoprotein preservation, one will be placed in RNAlater for nucleic acid preservation and the other one will be placed in formalin for FFPE. Additionally, blood samples will be collected at different time points during treatment.

MeSH Terms

Conditions

Triple Negative Breast NeoplasmsBreast NeoplasmsNeoplasm Metastasis

Interventions

Biopsy, Large-Core Needle

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy, NeedleBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativePuncturesInvestigative Techniques

Study Officials

  • Mark Basik, MD

    Segal Cancer Centre, Jewish General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2011

First Posted

January 13, 2011

Study Start

September 1, 2010

Primary Completion

September 1, 2015

Last Updated

June 2, 2022

Record last verified: 2022-05

Locations

CA(7)US(1)