Status:
UNKNOWN
Informative Tools to Optimize Neoadjuvant Therapy in ER Positive, HER2 Negative Breast Cancers
Lead Sponsor:
British Columbia Cancer Agency
Collaborating Sponsors:
Genomic Health®, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-89 years
Phase:
NA
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 M...
Detailed Description
Based on what is known about the treatment of breast cancer, there are occasional advantages to giving treatment before surgery. Some of these advantages can include shrinking a large breast cancer to...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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:
- 1\. Patients with a pacemaker or contra-indication to MRI.
Key Trial Info
Start Date :
January 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03790813
Start Date
January 7 2019
End Date
December 31 2023
Last Update
January 2 2019
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