Informative Tools to Optimize Neoadjuvant Therapy in ER Positive, HER2 Negative Breast Cancers

NCT03790813 | Unknown

• 1 other identifier: H18-02581
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the addition of Ki-67, Oncotype DX and MRI in the treatment of early stage breast cancer with neoadjuvant treatment. All enrolled patients will have Ki-67 and Oncotype AND/OR an MRI before and after surgery.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Feasibility of neoajduvant Ki-67 and Oncotype DX, defined as >=75% enrollment rate for all screened patients

  • Technical feasibility of obtaining Ki-67 and Oncotype DX assay from a core biopsy sample in \>= 75% of samples tested, prior to the initiation of systemic treatment.

  1 month

• Turnaround time of Ki-67 and Oncotype DX, defined as time from patient consent to date results are obtained

  * Turnaround time will be defined as: * Time from patient consent to reporting of the Ki-67 and Oncotype DX

  1 month

• Feasibility of MRI prior to neoadjuvant systemic treatment, defined as >=75% of patients who receive an MRI before the start of neoadjuvant treatment

  • Practical feasibility of obtaining serial MRIs with the existing means, resources and booking circumstances in \>=75% of cases prior to the initiation of systemic therapy and surgical resection

  6 months

• Turnaround time of MRI prior to neoadjuvant systemic treatment, defined as time from patient consent to date of 1st MRI

  Turnaround time will be defined as: • Time from patient consent to pre-treatment (baseline) MRI

  6 months

Secondary Outcomes (6)

• Correlation of Ki-67 and Oncotype DX to each other and to the outcome of neoadjuvant systemic treatment.

  6 months

• Predictive association of Ki-67 and Oncotype to invasive locoregional or systemic relapse

  5 years

• Predictive association of Ki-67 and Oncotype to overall survival

  5 years

• Impact of serial MRI on changes to surgical planning

  6 months

• Correlation of serial MRI to clinical and pathological response

  6 months

Study Arms (1)

Eligible patients

EXPERIMENTAL

Diagnostic Test: Intervention 1; Diagnostic Test: Intervention 2

Interventions

Intervention 1 DIAGNOSTIC_TEST

Ki-67 and Oncotype DX® will be performed on the baseline core biopsy specimen prior to initiation of neoadjuvant systemic therapy.

Eligible patients

Intervention 2 DIAGNOSTIC_TEST

MRI will be performed prior to initiation of neoadjuvant systemic therapy and at the end of treatment.

Eligible patients

Eligibility Criteria

• Age: 18 Years - 89 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be between the ages (inclusive) of 18-89.
• Patient has adequate performance status (PS ECOG 0,1 or Karnofsky performance status ≥70) and is a medically fit candidate for treatment of their cancer with systemic chemotherapy and/or hormonal therapy with no contra-indications to both systemic therapy options.
• Patient is medically fit enough to be a surgical candidate.
• Patient must be able to give informed consent directly or through the assistance of an interpreter.
• Pathological confirmation of breast cancer by core biopsy.
• Ductal or lobular breast cancer.
• Breast cancer with a primary tumour (clinically selected T2-T4) OR clinically node positive.
• Breast cancer is clinically palpable either in the breast, axilla or other nodal site.
• ER positive by IHC (Allred \>=4).
• Her2Neu negative by IHC (0 or 1+) or FISH by current ASCO/CAP guidelines.

You may not qualify if:

• Patient is a male with breast cancer.
• Patients have ER negative tumors (ER-) by local or central BCCA assessment.
• Patients have HER2 positive tumors by local or central BCCA assessment.
• Patients have known metastatic breast cancer or develop metastatic disease prior to surgery.
• Patients are unable to give consent or understand written language.
• Patients with poor performance status (ECOG 2-4) in whom consideration of neoadjuvant chemotherapy OR hormonal therapy would be contraindicated.
• Patients who are not fit enough to be a surgical candidate.
• Pregnant women in whom consideration of neoadjuvant chemotherapy or neoadjuvant hormonal therapy would be contraindicated.
• Patients who receive less than 2 weeks of neoadjuvant systemic therapy.
• Patients who have not undergone surgical resection 12 months after enrollment.
• For intervention 1 only:
• Patients with tumors that on GHI central pathological review appears inadequate for the Oncotype DX® assay.
• Patients with tumors that on BCCA pathological review appears inadequate for Ki-67 immunohistochemistry.
• For intervention 2 only:
• \. Patients with a pacemaker or contra-indication to MRI.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• Genomic Health®, Inc.: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Stephen Chia, MD

  BCCA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie LeVasseur, MD

CONTACT

604-877-6000x2734; nathalie.levasseur@bccancer.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair- British Columbia Breast Tumour Group

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: January 2, 2019
• Study Start: January 7, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2023
• Last Updated: January 2, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share