TME Neoadjuvant Breast Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2022-07-31

Brief Summary

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Prospective observational registry that links results of the genomic and other molecular testing to treatment response and survival measures in patients who have been diagnosed with breast cancer and who are targeted for neo-adjuvant therapy. Analysis includes how tests impact treatment decisions and outcomes.

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Detailed Description

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Physicians will order tests on patients as part of standard of care; they will report whether test results influenced: selection between standard therapies or a clinical trial; offered insight into mid therapy treatment changes; or helped physicians determine what therapy to offer patients who do not have a complete pathologic response. Patient demographics, diagnosis, type of treatment, surgery and pathologic results will be recorded. Patients will be followed for 5 years. Recurrence and survival data will be recorded.

Participating sites will submit de-identified patient data via electronic case report forms (eCRFs) into a secure study website.

All patients are required to sign an Informed Consent Form. All investigators and staff will have Human Subject Protection Training.

Conditions

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Breast Cancer Breast Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Genomic and/or molecular testing of blood or tissue

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with histologically proven invasive breast cancer who have started or are scheduled to start neo-adjuvant chemotherapy or endocrine therapy
* Ages 18-90
* Written informed consent

Exclusion Criteria

* Patients who have had excisional biopsy or axillary dissection
* Patients with confirmed metastatic disease
* Patients who have had recent chemotherapy

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No